StudyFinder
Search Results
Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Search all categories
632 Study Matches
Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
ctrrecruit@vcu.edu
NCT06580314
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types:
* High grade serous
* High grade endometrioid, and/or
* Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic)
* Submission of pathology report is required
* Ovarian cancer = ovarian, fallopian, or primary peritoneal cancer
* Patients must have:
* Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration)
* Submission of testing report is required. OR
* BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory (e.g., Myriad MyChoice©)
* Submission of testing report is required
* Patient must have undergone cytoreductive surgery (primary or interval)
* Patients must have completed first line platinum-based therapy prior to registration:
* Platinum based chemotherapy course must have consisted of a minimum of 4 treatment cycles and a maximum of 9, although it is strongly recommended that patients receive at least 6 cycles unless medically contraindicated
* For those receiving less than 6 cycles of platinum-based therapy, the reason for this must be documented and could include hematologic toxicity or non-hematologic toxicities directly related to therapy
* Intravenous, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle
* Patients must not have received an investigational agent during their first line course of chemotherapy
* Patients must have, in the opinion of the investigator, no clinical evidence of disease progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy)
* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy)
* Patients must be randomized at least 3 weeks and no more than 12 weeks after their last dose of chemotherapy (last dose is the day of the last infusion of platinum agent)
* No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Not pregnant and not nursing
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
* Platelets ≥ 100,000 cells/mm\^3
* Hemoglobin ≥ 9 g/dl
* Creatinine clearance (CrCL) of \> 30 mL/min by the Cockcroft-Gault formula
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* No active infection requiring parental antibiotic(s)
* No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
* No current inability to swallow orally administered medication
* No history of myelodysplastic syndrome and/or acute myeloid leukemia
* No history of allogeneic bone marrow transplant
* No concomitant use of strong or moderate CYP3A inducers
* No known hypersensitivity to olaparib or any of the excipients of the product BIOLOGICAL: Bevacizumab, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, DRUG: Olaparib
Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, FIGO Stage III Ovarian Cancer 2014, FIGO Stage IV Ovarian Cancer 2014, Ovarian Carcinoma, Ovarian High Grade Endometrioid Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal Endometrioid Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma
I'm interested
Share via email
Show 676 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate High Tech Medical Park Palos Heights, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Outpatient Center - Oak Lawn Oak Lawn, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alegent Health Bergan Mercy Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Immanuel Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Lakeside Hospital Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Avera Cancer Institute Sioux Falls, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute - Mitchell Mitchell, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Marshall Marshall, Minnesota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Pierre Pierre, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Yankton Yankton, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute-Aberdeen Aberdeen, South Dakota | Site Public Contact - (oncregulatory@avera.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Baptist Health Corbin Corbin, Kentucky | |
| Baptist Health Lexington Lexington, Kentucky | |
| Baptist Health Louisville Louisville, Kentucky | Site Public Contact - (Cbcresearch@bhsi.com) |
| Baptist Health Paducah Paducah, Kentucky | |
| Bay Area Hospital Coos Bay, Oregon | Site Public Contact - (cherie.cox@bayareahospital.org) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe Medical Center Lewes, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Bellevue Hospital Center New York, New York | Site Public Contact - (david.wallach@nyulangone.org) |
| Benefis Helena Specialty Center Helena, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bethesda North Hospital Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Billings Clinic-Cody Cody, Wyoming | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| CHI Health Good Samaritan Kearney, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CHI Health Saint Francis Grand Island, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| California Pacific Medical Center-Pacific Campus San Francisco, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Cambridge Medical Center Cambridge, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Camden Clark Medical Center Parkersburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Northwest - Spokane South Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Northwest-North Spokane Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Northwest-Valley Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (Roster@nrgoncology.org) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Center-Metro Medical Center Bayamon Bayamón, | |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle BroMenn Outpatient Center Bloomington, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Garden City Garden City, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | Site Public Contact - (aroland@kccop.org) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (Roster@nrgoncology.org) |
| Chambersburg Hospital Chambersburg, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Chester County Hospital West Chester, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| Christiana Care - Union Hospital Elkton, Maryland | Site Public Contact - (frank.crum@christianacare.org) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Columbus Oncology and Hematology Associates Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| CommonSpirit Cancer Center Mercy Durango, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Commonwealth Cancer Center-Corbin Corbin, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cox Cancer Center Branson Branson, Missouri | |
| CoxHealth South Hospital Springfield, Missouri | |
| Creighton University Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Danbury Hospital Danbury, Connecticut | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Doctors Cancer Center Manati, | |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| East Jefferson General Hospital Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Eden Hospital Medical Center Castro Valley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Ehime University Hospital Tōon, Ehime | |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| Emory Decatur Hospital Decatur, Georgia | Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org) |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Ephrata Cancer Center Ephrata, Pennsylvania | |
| Essentia Health - Baxter Clinic Baxter, Minnesota | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Ely Clinic Ely, Minnesota | |
| Essentia Health - Fosston Fosston, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - International Falls Clinic International Falls, Minnesota | |
| Essentia Health - Jamestown Clinic Jamestown, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Moose Lake Clinic Moose Lake, Minnesota | |
| Essentia Health - Park Rapids Park Rapids, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Saint Joseph's Crosslake Clinic Crosslake, Minnesota | |
| Essentia Health - Saint Joseph's Pequot Lakes Clinic Pequot Lakes, Minnesota | |
| Essentia Health - Saint Joseph's Pine River Clinic Pine River, Minnesota | |
| Essentia Health - Saint Joseph's Staples Clinic Staples, Minnesota | |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center-South University Clinic Fargo, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin | |
| Essentia Health Saint Mary's Medical Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health-Hayward Clinic Hayward, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health-Spooner Clinic Spooner, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Northland Medical Center Princeton, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Flaget Memorial Hospital Bardstown, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Freeman Health System Joplin, Montana | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Fresno Cancer Center Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Geauga Hospital Chardon, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Genesee Hematology Oncology PC Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Glens Falls Hospital Glens Falls, New York | |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Goshen Center for Cancer Care Goshen, Indiana | Site Public Contact - (cccois@goshenhealth.com) |
| Grady Health System Atlanta, Georgia | |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Great Falls Clinic Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| Health Central Ocoee, Florida | Site Public Contact - (Roster@nrgoncology.org) |
| Health Partners Inc Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Heartland Oncology and Hematology LLP Council Bluffs, Iowa | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hematology Oncology Consultants-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Health Saint John Hospital Detroit, Michigan | Site Public Contact - (Kkeenan1@hfhs.org) |
| Henry Ford Health Warren Hospital Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Madison Heights Hospital - Breast Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford River District Hospital East China Township, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - GLCMS Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Hi-Line Sletten Cancer Center Havre, Montana | Site Public Contact - (Roster@nrgoncology.org) |
| Highlands Oncology Group Springdale, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Fayetteville Fayetteville, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Rogers Rogers, Arkansas | Site Public Contact - (research@hogonc.com) |
| Hillcrest Hospital Cancer Center Mayfield Heights, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Hokkaido University Hospital Sapporo, Hokkaido | Site Public Contact - (hassi@med.hokudai.ac.jp) |
| Holy Cross Hospital Fort Lauderdale, Florida | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hope Cancer Center Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Houston Methodist Hospital Houston, Texas | |
| Houston Methodist Saint John Hospital Nassau Bay, Texas | Site Public Contact - (Roster@nrgoncology.org) |
| Houston Methodist The Woodlands Hospital Shenandoah, Texas | Site Public Contact - (hmthewoodlands@houstonmethodist.org) |
| Houston Methodist West Hospital Houston, Texas | |
| Huntington Memorial Hospital Pasadena, California | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hyogo Cancer Center Akashi, Hyōgo | |
| IU Health North Hospital Carmel, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Idaho Urologic Institute-Meridian Meridian, Idaho | |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Intermountain Health West End Clinic Billings, Montana | |
| Iwate Medical University Hospital Morioka, | |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (Roster@nrgoncology.org) |
| Jikei University School of Medicine Minato-ku, Tokyo, | |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| John Muir Medical Center-Walnut Creek Walnut Creek, California | Site Public Contact - (clinicalresearch@johnmuirhealth.com) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Kagoshima City Hospital Kagoshima, Kagoshima-ken | |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Cancer Treatment Center South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Medical Center-Vacaville Vacaville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente Oakland-Broadway Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente South Bay Harbor City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente West Los Angeles Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente- Marshall Medical Offices Redwood City, California | |
| Kaiser Permanente- Modesto MOB II Modesto, California | |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Deer Valley Medical Center Antioch, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Irvine Irvine, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Richmond Richmond, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Riverside Riverside, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Stockton Stockton, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Katmai Oncology Group Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Keio University Shinjuku-ku, Tokyo | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kuakini Medical Center Honolulu, Hawaii | |
| Kure Medical Center and Chugoku Cancer Center Kure, Hiroshima | |
| LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Good Samaritan Hospital and Medical Center Portland, Oregon | Site Public Contact - (cancer@lhs.org) |
| Legacy Meridian Park Hospital Tualatin, Oregon | |
| Legacy Salmon Creek Hospital Vancouver, Washington | |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Longmont United Hospital Longmont, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri | |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Mary Greeley Medical Center Ames, Iowa | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Hermann Texas Medical Center Houston, Texas | |
| Memorial Hospital North Colorado Springs, Colorado | |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Hospital of Laramie County Cheyenne, Wyoming | Site Public Contact - (Roster@nrgoncology.org) |
| Memorial Hospital of South Bend South Bend, Indiana | |
| Memorial Medical Center Modesto, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Mercy Cancer Center Merced, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri | |
| Mercy Cancer Center - Carmichael Carmichael, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Elk Grove Elk Grove, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Rocklin Rocklin, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Sacramento Sacramento, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Joplin Joplin, Missouri | Site Public Contact - (esmeralda.carrillo@mercy.net) |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital Pittsburg Pittsburg, Kansas | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Hospital Washington Washington, Missouri | |
| Mercy Infusion Center - Chippewa St Louis, Missouri | |
| Mercy Medical Center Rockville Centre, New York | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (OncologyResearch@DignityHealth.org) |
| Methodist Jennie Edmundson Hospital Council Bluffs, Iowa | Site Public Contact - (kathryn.bartz@nmhs.org) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Methodist Willowbrook Hospital Houston, Texas | Site Public Contact - (Roster@nrgoncology.org) |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Mills Health Center San Mateo, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Mills-Peninsula Medical Center Burlingame, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mission Hope Medical Oncology - Santa Maria Santa Maria, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mount Sinai Chelsea New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai West New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| MyMichigan Medical Center Alpena Alpena, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Gladwin Gladwin, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Gratiot Alma, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Midland Midland, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Mount Pleasant Mount Pleasant, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| NYU Langone Hospital - Brooklyn Brooklyn, New York | Site Public Contact - (david.wallach@nyulangone.org) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha, Nebraska | |
| Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ Council Bluffs, Iowa | Site Public Contact - (Liza.brandes@nmhs.org) |
| Nebraska Methodist Hospital Omaha, Nebraska | |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Newland Medical Associates-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Newland Medical Associates-Pontiac Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northside Hospital Atlanta, Georgia | Site Public Contact - (ClinicalTrials@northside.com) |
| Northwest Cancer Center - Hobart Hobart, Indiana | |
| Northwest Cancer Center - Main Campus Crown Point, Indiana | |
| Northwest Cancer Center - Valparaiso Valparaiso, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Northwest Oncology LLC Dyer, Indiana | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Norwalk Hospital Norwalk, Connecticut | Site Public Contact - (jennifer.long@norwalkhealth.org) |
| OSF Saint Anthony's Health Center Alton, Illinois | |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ochsner Baptist Medical Center New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Marion General Hospital Marion, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth O'Bleness Hospital Athens, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Pickerington Methodist Hospital Pickerington, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Westerville Medical Campus/Westerville Cancer Center Westerville, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Okayama University Hospital Okayama, | Site Public Contact - (Roster@nrgoncology.org) |
| Oncology Associates PC Omaha, Nebraska | |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Orlando Health Cancer Institute Orlando, Florida | Site Public Contact - (CancerClinicalTrials@orlandohealth.com) |
| Orlando Health Cancer Institute - Lake Mary Lake Mary, Florida | Site Public Contact - (r-adultoncnewops@orlandohealth.com) |
| Our Lady of The Lake Baton Rouge, Louisiana | |
| Our Lady of the Lake Medical Oncology Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| PROncology San Juan, | Site Public Contact - (info@PRoncology.com) |
| Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Palo Alto Medical Foundation Health Care Palo Alto, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Camino Division Mountain View, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Fremont Fremont, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Gynecologic Oncology Mountain View, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Santa Cruz Santa Cruz, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Parkland Memorial Hospital Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| Parkview Regional Medical Center Fort Wayne, Indiana | |
| PeaceHealth Saint John Medical Center Longview, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | Site Public Contact - (achapman1@peacehealth.org) |
| PeaceHealth United General Medical Center Sedro-Woolley, Washington | Site Public Contact - (achapman1@peacehealth.org) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Pennsylvania Hospital Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Princeton Community Hospital Princeton, West Virginia | |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Hood River Memorial Hospital Hood River, Oregon | Site Public Contact - (canrsrchstudies@provdience.org) |
| Providence Medical Foundation - Santa Rosa Santa Rosa, California | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Queen of The Valley Napa, California | |
| Providence Regional Cancer Partnership Everett, Washington | Site Public Contact - (marilyn.birchman@providence.org) |
| Providence Regional Cancer System-Aberdeen Aberdeen, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Centralia Centralia, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California | Site Public Contact - (Najee.Boucher@providence.org) |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Santa Rosa Memorial Hospital Santa Rosa, California | |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Puerto Rico Hematology Oncology Group Bayamón, | |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Cancer Center - Pearlridge ‘Aiea, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridley-Tree Cancer Center Santa Barbara, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Riverwood Healthcare Center Aitkin, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Robert Wood Johnson University Hospital Somerset Somerville, New Jersey | Site Public Contact - (Siby.Varughese@rwjbh.org) |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Rohnert Park Cancer Center Rohnert Park, California | Site Public Contact - (Kpoct@kp.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| Sacred Heart Hospital Pensacola, Florida | Site Public Contact - (eebrou@ascension.org) |
| Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | |
| Saint Anthony Hospital Lakewood, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Anthony North Hospital Westminster, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Catherine Hospital Indianapolis, Indiana | Site Public Contact - (Roster@nrgoncology.org) |
| Saint Charles Health System Bend, Oregon | Site Public Contact - (nosall@stcharleshealthcare.org) |
| Saint Charles Health System-Redmond Redmond, Oregon | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint James Community Hospital and Cancer Treatment Center Butte, Montana | |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph London London, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Mount Sterling Mount Sterling, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph's Medical Center Stockton, California | |
| Saint Luke's Cancer Center - Allentown Allentown, Pennsylvania | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Hospital - Monroe Campus Stroudsburg, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Saint Luke's Hospital - Upper Bucks Campus Quakertown, Pennsylvania | |
| Saint Luke's Hospital-Anderson Campus Easton, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Saint Luke's University Hospital-Bethlehem Campus Bethlehem, Pennsylvania | |
| Saint Mary Corwin Medical Center Pueblo, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Saint Mary's Hospital Centralia, Illinois | |
| Saint Michael Cancer Center Silverdale, Washington | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Patrick Hospital - Community Hospital Missoula, Montana | Site Public Contact - (amy.hanneman@providence.org) |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| Saint Vincent Healthcare Billings, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| San Juan City Hospital San Juan, | |
| San Juan Community Oncology Group San Juan, | |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Santa Cruz Radiation Oncology Medical Group Santa Cruz, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sechler Family Cancer Center Lebanon, Pennsylvania | Site Public Contact - (doxenberg@wellspan.org) |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Sidney and Lois Eskenazi Hospital Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Skagit Regional Health Cancer Care Center Mount Vernon, Washington | Site Public Contact - (rcccclinicalresearch@skagitvalleyhospital.org) |
| Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| South Jordan Health Center South Jordan, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| South Sacramento Cancer Center Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stanford Cancer Center Emeryville Emeryville, California | Site Public Contact - (ccto-office@stanford.edu) |
| Stanford Cancer Center South Bay San Jose, California | Site Public Contact - (ccto-office@stanford.edu) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Summit Health - Florham Park Campus Florham Park, New Jersey | Site Public Contact - (mmackenzie@summithealth.com) |
| Summit Medical Group Berkeley Heights, New Jersey | Site Public Contact - (Roster@nrgoncology.org) |
| Sutter Auburn Faith Hospital Auburn, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Cancer Research Consortium Novato, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Davis Hospital Davis, California | Site Public Contact - (NCIclinicaltrials@sutterhealth.org) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Pacific Medical Foundation Santa Rosa, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Roseville Medical Center Roseville, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Solano Medical Center/Cancer Center Vallejo, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Ballard Campus Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Cherry Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Tamarack Health Hayward Medical Center Hayward, Wisconsin | |
| The Cancer Center of Hawaii-Liliha Honolulu, Hawaii | |
| The Cancer Center of Hawaii-Pali Momi ‘Aiea, Hawaii | |
| The Cancer Institute Hospital of JFCR Koto-ku, Tokyo | Site Public Contact - (gog-jpn@insti.kitasato-u.ac.jp) |
| The Cancer Institute of New Jersey Hamilton Hamilton, New Jersey | |
| The Community Hospital Munster, Indiana | |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The Permanente Medical Group-Roseville Radiation Oncology Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | Site Public Contact - (rohta@queens.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Tohoku University School of Medicine Sendai, Aoba-ku | Site Public Contact - (med-som@bureau.tohoku.ac.jp) |
| Torrance Memorial Physician Network - Cancer Care Torrance, California | Site Public Contact - (courtney.steeneken@tmphysicians.com) |
| Tower Cancer Research Foundation Beverly Hills, California | |
| TriHealth Cancer Institute-Anderson Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| TriHealth Cancer Institute-Westside Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth - Cherry Creek Denver, Colorado | Site Public Contact - (Roster@nrgoncology.org) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (Roster@nrgoncology.org) |
| UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado | |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UChicago Medicine AdventHealth Cancer Institute Hinsdale Hinsdale, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UH Seidman Cancer Center at Saint John Medical Center Westlake, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| United Hospital Center Bridgeport, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| University Cancer and Blood Center LLC Athens, Georgia | Site Public Contact - (research@universitycancer.com) |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Michigan - Brighton Center for Specialty Care Brighton, Michigan | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| University of Rochester Rochester, New York | |
| University of Utah Sugarhouse Health Center Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| University of Washington Medical Center - Northwest Seattle, Washington | |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Radiation Oncology Peru, Illinois | |
| Vanderbilt Breast Center at One Hundred Oaks Nashville, Tennessee | |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vanderbilt-Ingram Cancer Center Cool Springs Franklin, Tennessee | |
| Vanderbilt-Ingram Cancer Center at Franklin Franklin, Tennessee | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| WVUH-Berkely Medical Center Martinsburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| WellSpan Health-York Cancer Center York, Pennsylvania | |
| WellSpan Health-York Hospital York, Pennsylvania | |
| WellSpan Medical Oncology and Hematology Hanover, Pennsylvania | |
| West Jefferson Medical Center Marrero, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Western Illinois Cancer Treatment Center Galesburg, Illinois | |
| Wheeling Hospital/Schiffler Cancer Center Wheeling, West Virginia | |
| Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii | |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Women and Infants Hospital Providence, Rhode Island | |
| Women's Diagnostic Center - Munster Munster, Indiana | Site Public Contact - (mnicholson@comhs.org) |
| Woodland Memorial Hospital Woodland, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer (SUNRAY-01)
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or - LillyTrials@Lilly.com
NCT06119581
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
* Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).
* Must have disease with evidence of KRAS G12C mutation.
* Must have known programmed death-ligand 1 (PD-L1) expression
* Part A: Greater than or equal to (≥)50 percent (%).
* Part B: 0% to 100%.
* Part C: \<50%.
* Must have measurable disease per RECIST v1.1.
* Must have an ECOG performance status of 0 or 1.
* Estimated life expectancy ≥12 weeks.
* Ability to swallow capsules.
* Must have adequate laboratory parameters.
* Contraceptive use should be consistent with local regulations for those participating in clinical studies.
* Women of childbearing potential must
* Have a negative pregnancy test.
* Not be breastfeeding during treatment
Exclusion Criteria:
* Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3.
* Have had any of the following prior to randomization:
\-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.
\--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:
* Have known active central nervous system metastases and/or carcinomatous meningitis.
Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)
* Have predominantly squamous cell histology for NSCLC
* Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed
* Is unable or unwilling to take folic acid or vitamin B12 supplementation. DRUG: LY3537982, DRUG: Pembrolizumab, DRUG: Placebo, DRUG: Cisplatin, DRUG: Carboplatin, DRUG: Pemetrexed
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
Advanced Non-Small Cell Lung Cancer, KRAS G12 Lung Cancer, Advanced Lung Cancer, Metastatic Lung Cancer, KRAS G12C inhibitor, KRAS G12C Positive, KRAS Mutation, KRAS G12 Mutation, Lung Cancer Mutation, Olomorasib, Lung Diseases, Neoplastic Processes, Pathologic Processes, Neoplasm Metastasis, Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer (NSCLC), Antineoplastic Agents, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Lung Neoplasms
I'm interested
Share via email
Show 423 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| "Theagenio" Cancer Hospital of Thessaloniki Thessaloniki, | |
| AZ Glorieux Ronse Ronse, | |
| AZ Groeninge Campus Kennedylaan Kortrijk, | |
| AZ Sint-Jan Brugge-Oostende AV Bruges, West-vlaanderen | |
| AZ Sint-Maarten Mechelen, | |
| Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital Ankara, | |
| Aberdeen Royal Infirmary Aberdeen, | |
| Actualidad Basada en la Investigación del Cáncer Guadalajara, | |
| Adana City Hospital Adana, | |
| Adana Medical Park Seyhan Hastanesi Adana, | |
| Advanced Centre for Treatment Research and Education in Cancer Navi Mumbai, | |
| Affiliated Hospital of Guangdong Medical University Zhanjiang, | |
| Agios Savvas Regional Cancer Hospital Athens, | |
| Aichi Cancer Center Hospital Nagoya, | |
| Akdeniz Universitesi Hastanesi Antalya, | |
| Akershus universitetssykehus Lørenskog, | |
| All India Institute of Medical Sciences Delhi, New Delhi | |
| Allina Health Cancer Institute - Abbott Northwestern Hospital Minneapolis, Minnesota | |
| Ankara Bilkent Sehir Hastanesi Bilkent Ankara, Ankara | |
| Ankara Etlik City Hospital Ankara, | |
| Antalya Egitim ve Arastırma Hastanesi Antalya, | |
| Arké SMO S.A de C.V Veracruz, | |
| Asan Medical Center Seoul, | |
| Asante Rogue Regional Medical Center Medford, Oregon | |
| Ashwin Hospital Coimbatore, | |
| Asklepios Fachkliniken München-Gauting Gauting, | |
| Asklepios Klinik Harburg Hamburg, | |
| Attikon General University Hospital Chaïdári, | |
| Avix Investigacion Clinica, S.C. Monterrey, | |
| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento Verona, | |
| BASS Cancer Center Walnut Creek, California | |
| BC Cancer Abbotsford Abbotsford British Columbia, | |
| BC Cancer Vancouver Vancouver, | |
| Bacs-Kiskun Megyei Korhaz Kecskemét, | |
| Ballarat Health Services Ballarat Central, | |
| Banner MD Anderson Cancer Center Gilbert, Arizona | |
| Banner University Medical Center Phoenix Phoenix, Arizona | |
| Baptist Memorial Hospital-Memphis Memphis, Tennessee | |
| Beijing Cancer Hospital Beijing, | |
| Bezmialem Vakf Üniversitesi Istanbul, | |
| Boston Medical Center Boston, Massachusetts | |
| Brooke Army Medical Center Houston, Texas | |
| Budapesti Uzsoki Utcai Korhaz Budapest, | |
| Buddhist Dalin Tzu Chi General Hospital Chiayi City, | |
| CEDOES Vitória, | |
| CHI Saint Joseph Cancer Center - East Lexington, Kentucky | |
| CHIREC - site delta Auderghem, | |
| CHU Bordeaux Haut-Leveque Pessac, | |
| CHU Lille - Institut Coeur Poumon Lille, | |
| CHU de Toulouse - Hopital Larrey Toulouse, | |
| CHUAC-Hospital Teresa Herrera A Coruña, | |
| CHUS - Hospital Clinico Universitario Santiago de Compostela, | |
| CHUV (centre hospitalier universitaire vaudois) Lausanne, | |
| CIO - Centro de Inmuno-Oncología de Occidente Guadalajara, | |
| CIUSSS- saguenay-Lac-Saint-Jean Chicoutimi, | |
| COE Ensino e Pesquisa São José dos Campos, | |
| Cabinet Medical Oncomed Timișoara, | |
| Cancer Hospital Chinese Academy of Medical Science Beijing, | |
| Cedars-Sinai Medical Center Beverly Hills, California | |
| Centre Antoine-Lacassagne Nice, | |
| Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy, | |
| Centre Hospitalier Universitaire de Poitiers Poitiers, | |
| Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes, | |
| Centre Hospitalier intercommunal de Toulon La Seyne sur Mer Toulon, | |
| Centre Leon Berard Lyon, | |
| Centro Hospitalar E Universitário De Coimbra Coimbra, | |
| Centro Hospitalar do Porto - Hospital de Santo António Porto, | |
| Centro Onco-Hematológico Roma (COHR) Mexico City, | |
| Centro Paulista de Oncologia Clínica São Paulo, | |
| Centro de Investigacion Clinica de Oaxaca Oaxaca City, | |
| Centro de Pesquisa Clínica do Instituto do Câncer do Ceará Fortaleza, | |
| Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA Rio de Janeiro, | |
| Centrul de Oncologie "Sfântul Nectarie" Craiova, | |
| Champalimaud Foundation Lisbon, | |
| Chang Gung Medical Foundation-LinKou Branch Taoyuan District, | |
| Chang Gung Memorial Hospital at Kaohsiung Kaohsiung Niao Sung Dist, | |
| Changhua Christian Hospital Changhua, | |
| Charite Campus Virchow-Klinikum Berlin, | |
| Chi Mei Hospital - Liouying Branch Tainan, | |
| Chi Mei Medical Center Tainan, | |
| Chonnam National University Hwasun Hospital Jeollanam-do, | |
| Chung Shan Medical University Hospital Taichung, | |
| Chungbuk National University Hospital Cheongju-si, | |
| Clearview Cancer Institute Huntsville, Alabama | |
| Clinica Amo - Rio Vermelho Salvador, | |
| Clinica Integral Internacional de Oncología Puebla City, | |
| Clinique Saint Pierre Ottignies, | |
| Community Cancer Center North Indianapolis, Indiana | |
| Complejo Asistencial Universitario de León - Hospital de León León, | |
| Complejo Hospitalario de Navarra Pamplona, | |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | |
| Comprehensive Hematology Oncology St. Petersburg, Florida | |
| Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire | |
| Dicle Üniversitesi Diyarbakır, | |
| Drammen Sykehus, Vestre Viken HF Drammen, | |
| Duke Cancer Institute Durham, North Carolina | |
| ETZ Elisabeth Tilburg, | |
| Ege Universitesi Hastanesi Izmir, | |
| Emory University School of Medicine- Grady Campus Atlanta, Georgia | |
| Erasmus Medisch Centrum Rotterdam, | |
| Errikos Dunant Hospital Center Athens, | |
| European Interbalkan Medical Center Thessaloniki, | |
| Evangelische Lungenklinik Berlin Berlin, | |
| Faculdade de Medicina do ABC Santo André, São Paulo | |
| Fakultni nemocnice Bulovka Prague, | |
| Farkasgyepui Tudogyogyintezet Farkasgyepű, | |
| Fondazione IRCCS Istituto Nazionale dei Tumori Milan, | |
| Fondazione Policlinico Universitario Agostino Gemelli Roma, | |
| Franciscan Health Indianapolis, Indiana | |
| Franziskus-Hospital Harderberg Georgsmarienhütte, | |
| Frisius Medisch Centrum Leeuwarden, | |
| Fujian Cancer Hospital Fuzhou, Fujian | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto, | |
| Fundação Pio XII - Hospital de Câncer de Barretos Jaú, São Paulo | |
| G. Papanikolaou General Hospital Thessaloniki, | |
| Gangnam Severance Hospital, Yonsei University Health System Gangnam-gu, Seoul-teukbyeolsi [seoul] | |
| Gold Coast University Hospital Southport, | |
| Gosford Hospital Gosford, | |
| Goulburn Valley Health Shepparton, | |
| Gral Medical Diagnostic Center Bucharest, | |
| Grant Medical Foundation - Ruby Hall Clinic Pune, | |
| Gustave Roussy Villejuif, | |
| H.R.U Málaga - Hospital General Málaga, | |
| HCG Manavata Cancer Centre Mumbai, Nashik | |
| HELIOS Klinikum Erfurt Erfurt, | |
| Hainan General Hospital Haikou, | |
| Hanyang University Seoul Hospital Seoul, | |
| Harbin Medical University Cancer Hospital Harbin, Heilongjiang | |
| Haukeland Universitetssjukehus Bergen, | |
| Health Pharma Professional Research S.A. de C.V: Mexico City, | |
| Health Pharma Querétaro Juriquilla, | |
| HealthPartners Cancer Research Center Saint Paul, Minnesota | |
| Helios Klinikum Emil von Behring Berlin-Zehlendorf Berlin, | |
| Hemato Oncology Clinic Ahmedabad, | |
| Highlands Oncology Group Springdale, Arkansas | |
| Higiea Oncologia Mexico City, | |
| Himeji Medical Center Himeji, | |
| Hokkaido University Hospital Sapporo, Hokkaido | |
| Hopital Foch Suresnes, | |
| Hospices Civils de Lyon - Hopital Louis Pradel Bron, | |
| Hospital BP São Paulo, | |
| Hospital Brasilia Lago Sul, | |
| Hospital Clinico Universitario Lozano Blesa Zaragoza, | |
| Hospital Clinico de Valencia Valencia, | |
| Hospital Cuf porto Porto, | |
| Hospital Infanta Cristina Badajoz, | |
| Hospital Insular de Gran Canaria Las Palmas de Gran Canaria, | |
| Hospital Jerez de la Frontera Jerez de la Frontera, | |
| Hospital Paulistano São Paulo, | |
| Hospital Pulido Valente Lisbon, | |
| Hospital Santa Catarina - Paulista São Paulo, | |
| Hospital Sao Domingos São Luís, Maranhão | |
| Hospital Sao Lucas da PUCRS Porto Alegre, Rio Grande do Sul | |
| Hospital Sirio Libanes São Paulo, São Paulo | |
| Hospital Tacchini Bento Gonçalves, | |
| Hospital Universitari Dexeus Barcelona, | |
| Hospital Universitari Son Espases Palma de Mallorca, | |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey, | |
| Hospital Universitario 12 de Octubre Madrid, | |
| Hospital Universitario Quironsalud Madrid Madrid, | |
| Hospital Universitario Ramon y Cajal Madrid, | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital Universitário Evangélico Mackenzie Curitiba, | |
| Hospital da Luz Lisboa Lisbon, | |
| Hospital de Cancer de Londrina Londrina, | |
| Houston Methodist Hospital Houston, Texas | |
| Hualien Tzu Chi Medical Center Hualien City, | |
| Huddersfield Royal Infirmary Huddersfield, | |
| Hunan Cancer Hospital Changsha, | |
| Hunan Cancer Hospital Changsha, | |
| Hämato-Onkologie Hamburg, Prof. Laack und Partner Hamburg, | |
| Hôpital Robert Schuman Vantoux, | |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna, | |
| Ibaraki Prefectural Central Hospital Kasama, | |
| Icesp - Instituto Do Câncer Do Estado de São Paulo São Paulo, | |
| Icon Cancer Centre Wesley Auchenflower, | |
| Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana | |
| Institut Curie Paris, | |
| Institut Jean Godinot Reims, | |
| Institut de Cancerologie de l'Ouest Saint-Herblain, | |
| Instituto Catalan de Oncologia - Hospital Duran i Reynals Hospitalet, | |
| Instituto D'Or Pesquisa e Ensino Rio de Janeiro, | |
| Instituto D'Or de Pesquisa e Ensino (IDOR) São Paulo, | |
| Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA Rio de Janeiro, | |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE Porto, | |
| Instituto Tumori Giovanni Paolo II Bari, | |
| Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T São Paulo, | |
| Institutul Oncologic Cluj-Napoca, | |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale Naples, | |
| Istituto Nazionale Tumori Regina Elena Rome, | |
| Istituto Oncologico Veneto IRCCS Padua, | |
| Japanese Foundation for Cancer Research Kōtō City, | |
| Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry, | |
| Jeroen Bosch Hospital 's-Hertogenbosch, | |
| Jilin Province Tumor Hospital Changchun, | |
| Jinan Central Hospital Jinan, Shandong | |
| Johns Hopkins Bayview Medical Center Baltimore, Maryland | |
| Juntendo University Hospital Bunkyo-ku, Tokyo | |
| KLES Dr. Prabhakar Kore Hospital & M.R.C Belagavi, | |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | |
| Kaiser Permanente Interstate Medical Office Central Portland, Oregon | |
| Kanagawa Cancer Center Yokohama, Kanagawa | |
| Kanagawa Cardiovascular and Respiratory Center Kanagawa, Yokohama, | |
| Kanazawa University Hospital Kanazawa-shi, Ishikawa, | |
| Kansai Medical University Hospital Hirakata, Osaka | |
| Kantonsspital Winterthur Winterthur, | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | |
| Karmanos Cancer Institute Detroit, Michigan | |
| Keimyung University Dongsan Hospital Daegu, | |
| Kindai University Hospital- Osakasayama Campus Sakai, | |
| Klinik Floridsdorf Vienna, | |
| Klinikum Chemnitz Chemnitz, Saxony | |
| Klinikum Nürnberg Nord Nuremberg, | |
| Kobe City Medical Center General Hospital Kobe, | |
| Kocaeli Üniversitesi Kocaeli, | |
| Kolhapur Cancer Centre Private Limited Kolhāpur, | |
| Korea University Anam Hospital Seoul, Seoul-teukbyeolsi [seoul] | |
| Korea University Guro Hospital Seoul, | |
| Krankenhaus Martha-Maria Halle-Dölau Halle, | |
| Krishna Institute of Medical Sciences - Karad Karad, | |
| Kyungpook National University Chilgok Hospital Daegu, | |
| Kyushu University Hospital Fukuoka, Fukuoka, | |
| Lahey Hospital & Medical Center Burlington, Massachusetts | |
| Landeskrankenhaus Feldkirch Feldkirch, | |
| Laura and Isaac Perlmutter Cancer Center New York, New York | |
| Leids Universitair Medisch Centrum Leiden, | |
| Lexington Medical Center West Columbia, South Carolina | |
| Lifepoint Multispeciality Hospital Pune, | |
| Lifespan Cancer Institute Providence, Rhode Island | |
| Liga Norte Riograndense Contra O Cancer Natal, | |
| Linyi Cancer Hospital Linyi, | |
| Liuzhou People's Hospital Liuchow, | |
| Lotus-Med Bucharest, | |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California | |
| LungenClinic Grosshansdorf Großhansdorf, | |
| MICS Centrum Medyczne Torun Torun, | |
| MV-Zentrum für Onkologie und Hämatologie Cologne, | |
| Mackay Base Hospital Mackay, | |
| Mahatma Gandhi Cancer Hospital and Research Institute Visakhapatnam, | |
| Maimonides Cancer Center Brooklyn, New York | |
| Manhattan Eye, Ear and Throat Hospital New York, New York | |
| Mary Bird Perkins Cancer Center Baton Rouge, Louisiana | |
| Medical University of South Carolina Charleston, South Carolina | |
| Medisch Spectrum Twente Enschede, | |
| Memorial Antalya Hospital Antalya, | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Cancer Center Merced, California | |
| Miami Cancer Institute at Baptist Health, Inc. Miami, Florida | |
| Millennium Oncology Research Clinic Hollywood, Florida | |
| Miyagi Cancer Center Natori, | |
| Mount Vernon Hospital Northwood, | |
| Mälarsjukhuset Eskilstuna, | |
| Nagasaki University Hospital Nagasaki, | |
| Nanjing First Hospital Nanjing, | |
| National Cancer Center Goyang-si, | |
| National Cancer Center Hospital East Kashiwa, Chiba | |
| National Cheng Kung University Hospital Tainan, | |
| National Hospital Organization Asahikawa Medical Center Asahikawa, | |
| National Hospital Organization Kinki-Chuo Chest Medical Center Osaka, Sakai, | |
| National Hospital Organization Kyushu Cancer Center Fukuoka, | |
| National Hospital Organization Shikoku Cancer Center Matsuyama, | |
| National Hospital Organization Yamaguchi Ube Medical Center Ube, | |
| National Taiwan University Cancer Center (NTUCC) Taipei, | |
| National Taiwan University Hospital Taipei, | |
| National Taiwan University Hospital - Hsinchu branch Zhubei, | |
| National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region Douliu, | |
| Nemocnice AGEL Ostrava - Vitkovice a.s. Ostrava, | |
| New Cross Hospital Wolverhampton, | |
| New Taipei Municipal TuCheng Hospital New Taipei City, | |
| Niigata Cancer Center Hospital Niigata, | |
| Ninewells Hospital and Medical School Dundee, | |
| Nizam's Institute of Medical Sciences Hyderabad, Andhra Pradesh | |
| North Mississippi Hematology and Oncology Associates Tupelo, Mississippi | |
| Northwell Health/ RJ Zuckerberg Cancer Center Lake Success, New York | |
| Nouvel Hôpital Civil (NHC) Strasbourg, | |
| Núcleo de Pesquisa Clínica da Rede São Camilo São Paulo, | |
| ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ijuí, | |
| OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces Barakaldo, | |
| Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala Ocala, Florida | |
| Okayama University Hospital Okayama, | |
| Oncare - Unidad Valle San Pedro Garza García, | |
| Oncology Hematology Associates Springfield, Missouri | |
| Oncominas Pouso Alegre, | |
| Ondokuz Mayıs Universitesi Samsun, | |
| One Day Med Szczecin, | |
| Onkologiezentrum Donauwörth Donauwörth, | |
| Ordensklinikum Linz GmbH Elisabethinen Linz, | |
| Orszagos Koranyi Pulmonologiai Intezet Budapest, | |
| Orszagos Onkologiai Intezet Budapest, | |
| Oslo universitetssykehus, Radiumhospitalet Oslo, | |
| Ospedale di Circolo e Fondazione Macchi Varese Varese, | |
| Ovidius Clinical Hospital OCH Ovidiu, | |
| Pacific Medical College & Hospital Udaipur, | |
| PanAmerican Clinical Research - Guadalajara Guadalajara, | |
| Parc de Salut Mar - Hospital del Mar Barcelona, Barcelona [barcelona] | |
| Parkview Research Center at Parkview Regional Medical Center Fort Wayne, Indiana | |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island Mineola, New York | |
| Policlinico "G. Rodolico" Catania, | |
| Preparaciones Oncológicas S.C. León, | |
| Prisma Health Cancer Institute Greenville, South Carolina | |
| Providence Portland Medical Center Portland, Oregon | |
| Providence St. Vincent Medical Center Portland, Oregon | |
| Pusan National University Yangsan Hospital Yangsan, Gyeongsangnam-do | |
| Regional Cancer Centre - Thiruvananthapuram Thiruvananthapuram, | |
| Renati Innovation Guadalajara, | |
| Renmin Hospital of Wuhan University Wuhan, | |
| Roskilde University Hospital Roskilde, | |
| Royal Adelaide Hospital Adelaide, South Australia | |
| S C Oncocenter Oncologie Clinica S R L Timișoara, | |
| SC Memorial Healthcare International SRL Bucharest, | |
| SRV Hospitals Bengaluru, | |
| SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical Madison, Wisconsin | |
| Sahyadri Super Speciality Hospital Pune, Maharashtra | |
| Sainte Catherine Institut du Cancer Avignon Provence Avignon, | |
| Saitama Medical University International Medical Center Saitama, | |
| Samsung Medical Center Seoul, Gangnam-gu | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Shandong Cancer Hospital Jinan, | |
| Shanghai Chest Hospital Shanghai, | |
| Shizuoka Cancer Center Nagaizumi-chō, | |
| Sibley Memorial Hospital Washington D.C., District of Columbia | |
| Sichuan Cancer Hospital Chengdu, | |
| Sir Charles Gairdner Hospital Nedlands, Western Australia | |
| Sir Run Run Shaw Hospital Hangzhou, | |
| Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul Brasília, | |
| Sotiria Thoracic Diseases Hospital of Athens Athens, | |
| Springfield Clinic Main Campus Springfield, Illinois | |
| St James's University Hospital Leeds, | |
| St Vincent'S Hospital Melbourne, | |
| St. Antonius Ziekenhuis, locatie Utrecht Utrecht, | |
| St. Olavs Hospital Trondheim, | |
| Stavanger Universitetssykehus Stavanger, | |
| Sunshine Coast University Hospital Birtinya, | |
| Swedish Cancer Institute - Edmonds Edmonds, Washington | |
| Swedish Medical Center Englewood, Colorado | |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej Kielce, | |
| Sykehuset Innlandet HF Gjøvik Gjøvik, | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Istanbul, | |
| Taichung Veterans General Hospital Taichung, | |
| Taipei Veterans General Hospital Taipei, | |
| Taizhou Hospital of Zhejiang Province Zhejiang, | |
| Tata Memorial Centre - Homi Bhabha Cancer Hospital Varanasi, | |
| Tennessee Oncology Nashville, Tennessee | |
| Tennessee Oncology Chattanooga Chattanooga, Tennessee | |
| Tergooiziekenhuizen, locatie Hilversum Hilversum, | |
| The Cancer & Hematology Centers Grand Rapids, Michigan | |
| The Catholic University Of Korea St. Vincent's Hospital Suwon, | |
| The Catholic University of Korea, Yeouido St. Mary's Hospital Seoul, | |
| The Christie NHS Foundation Trust Manchester, England | |
| The First Affiliated Hospital of Guangzhou Medical University Guangzhou, | |
| The First Affiliated Hospital of NanChang University Nanchang, | |
| The First Affiliated Hospital of Xi'An Jiaotong University Xi’an, Shanxi | |
| The First Affiliated Hospital, Zhejiang University Hangzhou, | |
| The First People's Hospital of Changzhou Changzhou, Jiangsu | |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T Columbus, Ohio | |
| The Third People's Hospital of Chengdu (CDTPH) Chengdu, | |
| The Townsville Hospital Townsville, | |
| The University of Arizona Cancer Center - North Campus Tucson, Arizona | |
| The University of Kansas Cancer Center - Westwood Westwood, Kansas | |
| The University of Vermont Medical Center Inc. Burlington, Vermont | |
| The Valley Hospital, Inc. Ridgewood, New Jersey | |
| Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office Philadelphia, Pennsylvania | |
| Thoraxklinik-Heidelberg gGmbH Heidelberg, | |
| Tianjin Medical University Cancer Institute & Hospital Tianjin, | |
| Tochigi Cancer Center Utsunomiya, | |
| Tokyo Metropolitan Komagome Hospital Bunkyō City, | |
| Tongji Hospital Tongji Medical,Science & Technology Wuhan, | |
| Tottori University Hospital Yonago, Tottori | |
| UNC REX Cancer Center Raleigh, North Carolina | |
| UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | |
| USO - Alliance Cancer Specialists, PC Horsham, Pennsylvania | |
| USO - Maryland Oncology Hematology Columbia, Maryland | |
| USO - Northwest Cancer Specialists Vancouver, Washington | |
| USO - Oncology Associates of Oregon Eugene, Oregon | |
| USO - Oncology Hematology Care Cincinnati, Ohio | |
| USO - Rocky Mountain Cancer Centers Lone Tree, Colorado | |
| USO - Texas Oncology Webster, Texas | |
| USO - Texas Oncology Webster, Texas | |
| USO - US Oncology Research Network Nashville, Tennessee | |
| USO - Virginia Cancer Specialists Fairfax, Virginia | |
| UZ Gent Ghent, Oost-Vlaanderen | |
| UZ Leuven Leuven, | |
| Uludag Universitesi Bursa, | |
| Universitaetsklinikum Freiburg Freiburg im Breisgau, | |
| Universitaetsklinikum Tuebingen Tübingen, | |
| Universitatsspital Zurich Zurich, | |
| University Cancer & Blood Center, LLC Athens, Georgia | |
| University General Hospital of Heraklion Heraklion, | |
| University Hospital of Patras Pátrai, | |
| University Hospital,Kyoto Prefectural University of Medicine Kyoto, | |
| University of Chicago Hospital Chicago, Illinois | |
| University of Florida - Jacksonville Jacksonville, Florida | |
| University of Illinois at Chicago Chicago, Illinois | |
| University of Kentucky Chandler Medical Center Lexington, Kentucky | |
| University of Michigan Ann Arbor, Michigan | |
| University of New Mexico Comprehensive Cancer Center Albuquerque, New Mexico | |
| University of North Carolina Medical Center Chapel Hill, North Carolina | |
| University of Tennessee Medical Center Knoxville, Tennessee | |
| University of Texas MD Anderson Cancer Center Houston, Texas | |
| University of Virginia Health System Charlottesville, Virginia | |
| Universitätsklinikum Münster - Albert Schweitzer Campus Münster, | |
| Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne Yvoir, | |
| VA Puget Sound Health Care System Seattle, Washington | |
| VCU Health Adult Outpatient Pavillion Richmond, Virginia | |
| Västmanlands Sjukhus Västerås Västerås, | |
| Wakayama Medical University Hospital Wakayama, | |
| Wannan Medical College Yijishan Hospital Wuhu, | |
| West China Hospital, Sichuan University Chengdu, | |
| Weston Park Hospital Sheffield, England | |
| William Beaumont Army Medical Center Fort Bliss, Texas | |
| Winship Cancer Institute, Emory University Atlanta, Georgia | |
| Wuhan Union Hospital Wuhan, | |
| Xiangyang Central Hospital Xiangyang, | |
| Xinjiang Medical University Cancer Hospital - Urumqi Ürümqi, | |
| Yale University School of Medicine North Haven, Connecticut | |
| Yichang Central People's Hospital Yichang, | |
| ZNA Middelheim Antwerp, | |
| Zhejiang Cancer Hospital Hangzhou, Zhejiang | |
| ZhuZhou Central Hospital Zhuzhou, | |
| Ziekenhuis St. Jansdal Harderwijk, | |
| zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi Izmir, | |
| İ.A.Ü VM Medical Park Florya Hastanesi Istanbul, |
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
Devon Noonan, PhD, MPH, FNP-BC - devon.noonan@duke.edu
NCT05008848
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Have a cancer diagnosis within the past 10 years, and can currently be receiving curative treatment
* Not currently on hospice
* Currently smokes \>= 5 cigarettes daily
* Lives in a nonmetro/rural county (defined as having a Rural Urban Continuum Code \[RUCC\] code of 4-9)
* Patient interested in participating in a smoking cessation program, and not currently participating in a smoking cessation clinical trial
* Not currently using any smoking cessation pharmacotherapy (e.g. nicotine replacement therapy, bupropion or varenicline), or currently participating in any cessation program
* Patient has a cell phone or smart phone device with texting ability
* In order to complete the mandatory patient-completed measures, participants must be able to speak and read English
* Age \>= 18 years
* Participant must be willing to provide a urine sample.
Exclusion Criteria:
* Psychiatric illness which would prevent the patient from giving informed consent
* Patients with impaired decision-making capacity are not eligible for this study. BEHAVIORAL: Smoking Cessation Intervention, OTHER: Health Promotion and Education, OTHER: Informational Intervention, OTHER: Questionnaire Administration
Cigarette Smoking-Related Carcinoma
I'm interested
Share via email
Show 215 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Adena Regional Medical Center Chillicothe, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Medford Hospital Medford, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Ballad Health Cancer Care - Bristol Bristol, Virginia | Site Public Contact - (charles.mays@balladhealth.org) |
| Ballad Health Cancer Care - Kingsport Kingsport, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Banner North Colorado Medical Center Greeley, Colorado | |
| Banner North Colorado Medical Center - Loveland Campus Loveland, Colorado | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Broadlawns Medical Center Des Moines, Iowa | |
| CHI Health Good Samaritan Kearney, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| CHI Health Saint Francis Grand Island, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Camden Clark Medical Center Parkersburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center of Acadiana Lafayette, Louisiana | |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle BroMenn Outpatient Center Bloomington, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Chesapeake Regional Medical Center Chesapeake, Virginia | Site Public Contact - (CancerCare@ChesapeakeRegional.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas | |
| CoxHealth South Hospital Springfield, Missouri | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dartmouth Cancer Center - North Saint Johnsbury, Vermont | Site Public Contact - (cancer.research.nurse@hitchcock.org) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Doctor's Hospital of Laredo Laredo, Texas | |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Durham VA Medical Center Durham, North Carolina | Site Public Contact - (VHADURcancertrials@va.gov) |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Ely Clinic Ely, Minnesota | |
| Essentia Health - International Falls Clinic International Falls, Minnesota | |
| Essentia Health - Park Rapids Park Rapids, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center-South University Clinic Fargo, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Flaget Memorial Hospital Bardstown, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Great Falls Clinic Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| HSHS Sacred Heart Hospital Eau Claire, Wisconsin | |
| HaysMed Hays, Kansas | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Hendrick Medical Center Abilene, Texas | |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Hunter Holmes McGuire Veterans Administration Medical Center Richmond, Virginia | Site Public Contact - (Regina.McClung@va.gov) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Inspira Medical Center Vineland Vineland, New Jersey | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Knox Community Hospital Mount Vernon, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Louisiana State University Health Science Center New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Low Country Cancer Care Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Margaret R Pardee Memorial Hospital Hendersonville, North Carolina | Site Public Contact - (pardeecancerresearch@unchealth.unc.edu) |
| Mary Imogene Bassett Hospital Cooperstown, New York | Site Public Contact - (CancerClinicalTrials@bassett.org) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Hospital of Sweetwater County Rock Springs, Wyoming | Site Public Contact - (tharris@sweetwatermemorial.com) |
| Memorial Medical Center-Las Cruces Las Cruces, New Mexico | Site Public Contact - (Deborah.Brown@LPNT.net) |
| Mercy Cancer Center-West Lakes Clive, Iowa | |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Health - Perrysburg Hospital Perrysburg, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northeast Georgia Medical Center Braselton Braselton, Georgia | Site Public Contact - (cancerpatient.navigator@nghs.com) |
| Northeast Georgia Medical Center-Gainesville Gainesville, Georgia | Site Public Contact - (cancerpatient.navigator@nghs.com) |
| Novant Health Breast Surgery - Greensboro Greensboro, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Cancer Institute - Kernersville Kernersville, North Carolina | Site Public Contact - (asmarrs@novanthealth.org) |
| Novant Health Cancer Institute - Mount Airy Mount Airy, North Carolina | Site Public Contact - (asmarrs@novanthealth.org) |
| Novant Health Cancer Institute - Thomasville Thomasville, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Colon and Rectal Clinic Clemmons, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Forsyth Medical Center Winston-Salem, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| OSF Saint Anthony Medical Center Rockford, Illinois | |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Princeton Community Hospital Princeton, West Virginia | |
| Regional Cancer Center at Johnson City Medical Center Johnson City, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| SSM Health Dean Medical Group - Baraboo Baraboo, Wisconsin | |
| SSM Health Dean Medical Group - Janesville Janesville, Wisconsin | |
| SSM Health Dean Medical Group - South Madison Campus Madison, Wisconsin | |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| SSM Health Saint Louis University Hospital St Louis, Missouri | |
| STCC at DHR Health Institute for Research and Development Edinburg, Texas | Site Public Contact - (dhrresearch@dhr-rgv.com) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Helena Hospital St. Helena, California | |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph London London, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Luke's Hospital Chesterfield, Missouri | Site Public Contact - (Rachel.varner@unitypoint.org) |
| Saint Luke's Hospital of Duluth Duluth, Minnesota | Site Public Contact - (kdean@slhduluth.com) |
| Saint Mary's Hospital Centralia, Illinois | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sentara Norfolk General Hospital Norfolk, Virginia | |
| Sentara Princess Anne Hospital Virginia Beach, Virginia | |
| Southeastern Medical Oncology Center-Clinton Clinton, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Sovah Health Martinsville Martinsville, Virginia | Site Public Contact - (sharon.hubbard@lpnt.net) |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| The Carle Foundation Hospital Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| The Iowa Clinic PC West Des Moines, Iowa | |
| The Longstreet Clinic - Gainesville Gainesville, Georgia | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UP Health System Marquette Marquette, Michigan | Site Public Contact - (Dianna.Larson@mghs.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| United Hospital Center Bridgeport, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Unity Hospital Fridley, Minnesota | |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Iowa Healthcare Cancer Services Quad Cities Bettendorf, Iowa | Site Public Contact - (katherine-daprile@uiowa.edu) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)
Patient Advocacy - clinicaltrials@sangamo.com
NCT06980948
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria
• Signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
• ≥ 18 years of age.
• Diagnostic characterization of peripheral neuropathy (small fiber predominant) according to the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities and Networks (ACTTION) criteria. a. Minimal large fiber polyneuropathy by clinical examination and by nerve conduction studies (NCS) during screening. NCS results may be based on unilateral assessment. However, bilateral SNAP responses must be within normal range for age and gender in the ulnar, radial, and sural nerves to enhance sensitivity of monitoring for DRG ganglionopathy post ST-503 dosing or sham procedure treatment. Only persons with normal SNAP responses may be enrolled.
• An IENFD punch skin biopsy demonstrating reduction below the 5th percentile of sex and age-adjusted normal values must be performed and sent for IENFD evaluation at the Cutaneous Nerve Lab at University of Utah.
• Medical record documentation that pain is refractory to 2 of 3 categories of first line medical therapy for at ≥ 6 months prior to screening. a. "Refractory to first line medical therapy" is defined as failure to have an average weekly pain score \< 5 after an adequate trial of two of three categories of first line medication treatments for neuropathic pain (tricyclic antidepressants, SNRI, or gabapentinoids).
• Average PI-NRS score ≥ 5 over seven-day pain assessment interval.
• Minimum acceptable PI-NRS reporting requirement for eligibility: Four of seven days with two daily PI-NRS scores (morning and afternoon) must be recorded with a single PI-NRS score (morning or afternoon) for the remaining three days.
• Subjects will not be told at any time that the eligibility requirement is an average PI-NRS ≥ 5, to avoid biasing the pain intensity scoring during the screening and baseline periods.
• Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 40 kg/m2
• Agreement to limit alcohol consumption to not more than one 12 oz beer, 5 oz glass of wine, or 2 oz of liquor daily for a minimum of two months after the procedure.
• Negative screening test for mycobacterium tuberculosis (MTB) within 1 year prior to consent.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria
• Serum sample positive for pre-existing anti-AAV9 antibodies per predefined cut point based on assay sensitivity.
• Drug- and alcohol-related:
• Persons using opioid analgesics for under 3 months or persons who are not on a stable dose of opioids; if on a stable dose, the dose may decrease over the course of the study but should not be increased.
• History of known alcohol abuse, opioid analgesic abuse, or illicit drug abuse within 2 years of Screening.
• Positive urine test for drugs of abuse (including opiates, benzodiazepines, amphetamines, cocaine, barbiturates, and phencyclidine) without prescription and investigator approval, at Screening and Day -1.
• Use of cannabinoids is not permitted.
• Persons with Fabry disease, fibromyalgia, peripheral neuropathies due to alcohol or drug toxicity, or diagnosed channelopathies (congenital insensitivity to pain, inherited erythromelalgia).
• Corticosteroid-related:
• Use of glucocorticoids except for topical or ophthalmic preparations within 6 weeks prior to screening visit
• Hypersensitivity or contraindications to corticosteroid use including but not limited to clinically significant osteoporosis, uncontrolled hypertension, poorly controlled diabetes, uncontrolled hyperlipidemia, or hypercholesterolemia
• Neurologic-related:
• Subjects with severe pain conditions other than SFN which would interfere with clinical study assessments
• Documented stroke or transient ischemic attack within 1 year prior to consent
• History of poorly controlled epilepsy or recurrent unexplained blackouts
• Procedure-related:
• Contraindications to LP, general anesthesia or sedation
• Any medical disorders that, in the opinion of the Investigator, could interfere with LP including but not limited to evidence for a pressure gradient between supratentorial and infratentorial compartments, Arnold-Chiari malformation, bleeding diathesis, clinically significant coagulopathy, thrombocytopenia, increased intracranial pressure, or spine disease or past surgical procedures involving the spine
• Infectious disease-related: a. Active viral infection or bacterial infection including but not limited to the following: i. Active Hepatitis A, B, or C infection * Patients with previous, adequately resolved hepatitis A, B or C are eligible for the study * Patients with chronic hepatitis B or C are not eligible for the study b. A severe infection (e.g., pneumonia, septicemia, central nervous system infections \[e.g., meningitis, encephalitis\]) within 12 weeks prior to Screening c. Patients who receive COVID-19 vaccine or booster will have a waiting period of 4 weeks or more before they may be dosed with ST-503, so that the vaccine response does not interfere with the gene therapy and vice versa. They should not receive a COVID-19 vaccine or booster within 4 weeks after subjects have been dosed with ST-503. Subjects should not receive any live-attenuated vaccine, for any disease, 2 weeks before and 20 weeks after the ST-503 or sham procedure administration.
• Endocrine-related: a. History or evidence of impaired glucose metabolism based on hemoglobin A1C level of ≥ 6.5%
• Cardiac- and circulatory system-related:
• History of unstable angina, myocardial infarction, or chronic heart failure within 1 year prior to consent
• Clinically significant primary valvular heart disease and/or prosthetic cardiac valve
• 12-lead ECG demonstrating QTcF (Fridericia's correction) \> 450 msec i. If QTcF exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility. The ECG can be repeated after the subject is supine for 10 minutes. A third ECG can be obtained after an additional 10 minutes while remaining supine. d. Presence of uncontrolled hypertension
• Hepatic disease- and hepatotoxic medication-related:
• Presence of clinically relevant liver disease
• Hepatic dysfunction as indicated by one or more of the following: i. Albumin ≤ 3.5 g/dL ii. Total bilirubin \> 1.5 x ULN and direct bilirubin ≥ 0.5 mg/dL iii. ALP \> 2 x ULN iv. ALT or AST \> 1.5 x ULN c. Hepatotoxic medications should be avoided during the study period including acetaminophen exceeding 4 gm/day unless essential to patient's treatment, approved by investigator, and hepatic dysfunction is not identified d. Hepatotoxic supplement use during the study period
• Hematologic-related:
• Personal or family history of coagulopathy
• Presence of condition or treatment associated with increased bleeding risk associated with LP
• Hematocrit \< 35% (assigned male at birth) or \< 32% (assigned female at birth)
• Absolute neutrophil count \< 2000 cells/µL
• International normalized rate (INR) above normal range for lab at study site
• Platelet count below laboratory lower limits of normal (LLN)
• Renal-related: a. History of chronic renal disease or creatinine ≥ 1.5 mg/dL
• Cancer-related: a. History of cancer, including B-cell cancers, within 5 years of Screening i. Exceptions to this exclusion are fully excised non-melanoma skin cancers, non-metastatic prostate cancer, and fully treated ductal carcinoma in situ of the breast, provided subject has been stable for at least 6 months
• Allergy- and immunology-related:
• History of severe allergic or anaphylactic reactions
• History of hypersensitivity to any inactive ingredient of the IP or to corticosteroids
• Chronic autoimmune disease that is being treated with immunosuppressants, including but not limited to corticosteroids
• Previous autologous or allogeneic bone marrow transplant, peripheral stem cell transplant or solid organ transplantation
• Previously received gene or cellular therapy
• Participation in other interventional studies during the period of current study participation
• Planned surgery within three months prior to consent or during the study
• Any active legal action related to pain disorder
• Any other reason that, in the opinion of the Site Investigator or the Study Medical Monitor, would render the subject unsuitable for participation in the study. A suicide risk of imminent risk of self-harm according to the C-SSRS is an exclusion criterion for the clinical study.
• Signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
• ≥ 18 years of age.
• Diagnostic characterization of peripheral neuropathy (small fiber predominant) according to the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities and Networks (ACTTION) criteria. a. Minimal large fiber polyneuropathy by clinical examination and by nerve conduction studies (NCS) during screening. NCS results may be based on unilateral assessment. However, bilateral SNAP responses must be within normal range for age and gender in the ulnar, radial, and sural nerves to enhance sensitivity of monitoring for DRG ganglionopathy post ST-503 dosing or sham procedure treatment. Only persons with normal SNAP responses may be enrolled.
• An IENFD punch skin biopsy demonstrating reduction below the 5th percentile of sex and age-adjusted normal values must be performed and sent for IENFD evaluation at the Cutaneous Nerve Lab at University of Utah.
• Medical record documentation that pain is refractory to 2 of 3 categories of first line medical therapy for at ≥ 6 months prior to screening. a. "Refractory to first line medical therapy" is defined as failure to have an average weekly pain score \< 5 after an adequate trial of two of three categories of first line medication treatments for neuropathic pain (tricyclic antidepressants, SNRI, or gabapentinoids).
• Average PI-NRS score ≥ 5 over seven-day pain assessment interval.
• Minimum acceptable PI-NRS reporting requirement for eligibility: Four of seven days with two daily PI-NRS scores (morning and afternoon) must be recorded with a single PI-NRS score (morning or afternoon) for the remaining three days.
• Subjects will not be told at any time that the eligibility requirement is an average PI-NRS ≥ 5, to avoid biasing the pain intensity scoring during the screening and baseline periods.
• Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 40 kg/m2
• Agreement to limit alcohol consumption to not more than one 12 oz beer, 5 oz glass of wine, or 2 oz of liquor daily for a minimum of two months after the procedure.
• Negative screening test for mycobacterium tuberculosis (MTB) within 1 year prior to consent.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria
• Serum sample positive for pre-existing anti-AAV9 antibodies per predefined cut point based on assay sensitivity.
• Drug- and alcohol-related:
• Persons using opioid analgesics for under 3 months or persons who are not on a stable dose of opioids; if on a stable dose, the dose may decrease over the course of the study but should not be increased.
• History of known alcohol abuse, opioid analgesic abuse, or illicit drug abuse within 2 years of Screening.
• Positive urine test for drugs of abuse (including opiates, benzodiazepines, amphetamines, cocaine, barbiturates, and phencyclidine) without prescription and investigator approval, at Screening and Day -1.
• Use of cannabinoids is not permitted.
• Persons with Fabry disease, fibromyalgia, peripheral neuropathies due to alcohol or drug toxicity, or diagnosed channelopathies (congenital insensitivity to pain, inherited erythromelalgia).
• Corticosteroid-related:
• Use of glucocorticoids except for topical or ophthalmic preparations within 6 weeks prior to screening visit
• Hypersensitivity or contraindications to corticosteroid use including but not limited to clinically significant osteoporosis, uncontrolled hypertension, poorly controlled diabetes, uncontrolled hyperlipidemia, or hypercholesterolemia
• Neurologic-related:
• Subjects with severe pain conditions other than SFN which would interfere with clinical study assessments
• Documented stroke or transient ischemic attack within 1 year prior to consent
• History of poorly controlled epilepsy or recurrent unexplained blackouts
• Procedure-related:
• Contraindications to LP, general anesthesia or sedation
• Any medical disorders that, in the opinion of the Investigator, could interfere with LP including but not limited to evidence for a pressure gradient between supratentorial and infratentorial compartments, Arnold-Chiari malformation, bleeding diathesis, clinically significant coagulopathy, thrombocytopenia, increased intracranial pressure, or spine disease or past surgical procedures involving the spine
• Infectious disease-related: a. Active viral infection or bacterial infection including but not limited to the following: i. Active Hepatitis A, B, or C infection * Patients with previous, adequately resolved hepatitis A, B or C are eligible for the study * Patients with chronic hepatitis B or C are not eligible for the study b. A severe infection (e.g., pneumonia, septicemia, central nervous system infections \[e.g., meningitis, encephalitis\]) within 12 weeks prior to Screening c. Patients who receive COVID-19 vaccine or booster will have a waiting period of 4 weeks or more before they may be dosed with ST-503, so that the vaccine response does not interfere with the gene therapy and vice versa. They should not receive a COVID-19 vaccine or booster within 4 weeks after subjects have been dosed with ST-503. Subjects should not receive any live-attenuated vaccine, for any disease, 2 weeks before and 20 weeks after the ST-503 or sham procedure administration.
• Endocrine-related: a. History or evidence of impaired glucose metabolism based on hemoglobin A1C level of ≥ 6.5%
• Cardiac- and circulatory system-related:
• History of unstable angina, myocardial infarction, or chronic heart failure within 1 year prior to consent
• Clinically significant primary valvular heart disease and/or prosthetic cardiac valve
• 12-lead ECG demonstrating QTcF (Fridericia's correction) \> 450 msec i. If QTcF exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility. The ECG can be repeated after the subject is supine for 10 minutes. A third ECG can be obtained after an additional 10 minutes while remaining supine. d. Presence of uncontrolled hypertension
• Hepatic disease- and hepatotoxic medication-related:
• Presence of clinically relevant liver disease
• Hepatic dysfunction as indicated by one or more of the following: i. Albumin ≤ 3.5 g/dL ii. Total bilirubin \> 1.5 x ULN and direct bilirubin ≥ 0.5 mg/dL iii. ALP \> 2 x ULN iv. ALT or AST \> 1.5 x ULN c. Hepatotoxic medications should be avoided during the study period including acetaminophen exceeding 4 gm/day unless essential to patient's treatment, approved by investigator, and hepatic dysfunction is not identified d. Hepatotoxic supplement use during the study period
• Hematologic-related:
• Personal or family history of coagulopathy
• Presence of condition or treatment associated with increased bleeding risk associated with LP
• Hematocrit \< 35% (assigned male at birth) or \< 32% (assigned female at birth)
• Absolute neutrophil count \< 2000 cells/µL
• International normalized rate (INR) above normal range for lab at study site
• Platelet count below laboratory lower limits of normal (LLN)
• Renal-related: a. History of chronic renal disease or creatinine ≥ 1.5 mg/dL
• Cancer-related: a. History of cancer, including B-cell cancers, within 5 years of Screening i. Exceptions to this exclusion are fully excised non-melanoma skin cancers, non-metastatic prostate cancer, and fully treated ductal carcinoma in situ of the breast, provided subject has been stable for at least 6 months
• Allergy- and immunology-related:
• History of severe allergic or anaphylactic reactions
• History of hypersensitivity to any inactive ingredient of the IP or to corticosteroids
• Chronic autoimmune disease that is being treated with immunosuppressants, including but not limited to corticosteroids
• Previous autologous or allogeneic bone marrow transplant, peripheral stem cell transplant or solid organ transplantation
• Previously received gene or cellular therapy
• Participation in other interventional studies during the period of current study participation
• Planned surgery within three months prior to consent or during the study
• Any active legal action related to pain disorder
• Any other reason that, in the opinion of the Site Investigator or the Study Medical Monitor, would render the subject unsuitable for participation in the study. A suicide risk of imminent risk of self-harm according to the C-SSRS is an exclusion criterion for the clinical study.
GENETIC: ST-503, PROCEDURE: Sham (No Treatment)
Chronic Neuropathic Pain
Small Fiber Neuropathy
I'm interested
Share via email
Show 10 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Columbia University New York, New York | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| HonorHealth Phoenix, Arizona | Study Coordinator - (rrohla@honorhealth.com) |
| Johns Hopkins University Columbia, Maryland | |
| Massachusetts General Hospital Boston, Massachusetts | Clinical Research Coordinator - (imccarthy2@mgh.harvard.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of North Carolina Medical Center Chapel Hill, North Carolina | |
| University of Utah Salt Lake City, Utah | |
| Vanderbilt University Nashville, Tennessee | |
| Virginia Commonwealth University Richmond, Virginia |
Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer
ctrrecruit@vcu.edu
NCT06388018
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Patients must have had surgery consisting of hysterectomy (total abdominal, laparoscopic or robotic-assisted) and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards (sentinel or full lymphadenectomy). There must be no macroscopic residual disease after surgery
* Patients must have histologically confirmed stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed
* Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2
* Patients' age must be \>= 18 years
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures
* Patient is able (i.e. sufficiently fluent) and willing to complete the patient reported outcomes (PRO) questionnaires in either English, French or a validated language. The baseline assessment must be completed within required timelines, prior to enrollment. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible
* Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits placed on patients being considered for this trial. The patient's city of residence may be required to verify their geographical proximity. (Call the CCTG office (613-533-6430) if questions arise regarding the interpretation of this criterion.) Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
* Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial
* Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy
* SUB-STUDY A: Patients with endometrial carcinoma (endometrioid, serous, clear cell, un-/dedifferentiated, carcinosarcoma, mixed), must have one of the following combinations of International Federation of Gynecology and Obstetrics (FIGO) stage, grade, and lymphovascular invasion (LVI):
* Cohort A1:
* Stage IA (not confined to polyp), grade 3, pN0, with or without LVI (Pelvic lymph node surgical assessment (sentinel or full lymphadenectomy) is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated.)
* Stage IB, grade 1 or 2, pNx/N0, with or without LVI
* Stage IB, grade 3, pN0, without substantial LVI (Pelvic lymph node surgical assessment (sentinel or full lymphadenectomy) is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated.)
* Stage II (microscopic), grade 1 or 2, pN0, without substantial LVI (Pelvic lymph node surgical assessment (sentinel or full lymphadenectomy) is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated.) (Substantial LVI is defined as \>= 3 foci per College of American Pathologists' reporting guideline)
* Cohort A2:
* Stage IA (not confined to polyp), grade 3, pNx, with or without LVI
* Stage IB, grade 3, pNx, with or without LVI
* Stage IB, grade 3, pN0, with substantial LVI (Substantial LVI is defined as \>= 3 foci per College of American Pathologists' reporting guideline)
* Stage II (microscopic), grade 1 or 2, pNx, with or without LVI
* Stage II (microscopic), grade 1 or 2, pN0, with substantial LVIƒõ
* Stage II (microscopic), grade 3, pNx/N0, with or without LVI
* Stage II non-microscopic, any grade, pNx/N0, with or without LVI
* Stage III, any grade, pNx/N0-2, with or without LVI
* Substantial LVI is defined as .3 foci per College of American Pathologists¡¦ reporting guideline
* SUB-STUDY A: Patients must have a molecular classification of POLE mutation.
* Note: patients in Cohort A2 should have a known POLE pathogenic mutation prior to consenting
* SUB-STUDY B: Patients with endometrial carcinoma (endometrioid only), must have one of the following combinations of FIGO stage, grade, and lymphovascular invasion (LVI):
* Stage IA (not confined to polyp), grade 3, pN0, with or without LVI (Pelvic lymph node surgical assessment \[sentinel or full lymphadenectomy\] is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated) (Substantial LVI is defined as \>= 3 foci per College of American Pathologists' reporting guideline)
* Stage IB, grade 1 or 2, pNx/N0, with or without LVI
* Stage IB, grade 3, pN0, without substantial LVI (Pelvic lymph node surgical assessment \[sentinel or full lymphadenectomy\] is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated) (Substantial LVI is defined as \>= 3 foci per College of American Pathologists' reporting guideline)
* Stage II (microscopic), grade 1 or 2, pN0\*, without substantial LVI (Pelvic lymph node surgical assessment \[sentinel or full lymphadenectomy\] is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated) (Substantial LVI is defined as \>= 3 foci per College of American Pathologists' reporting guideline)
* SUB-STUDY B: Patients must have molecular classification of p53wt/NSMP (based on normal p53 IHC, and absence of pathogenic POLE mutation or MMR deficiency)
* SUB-STUDY B: Estrogen receptor positive (\> 10% of the tumour with positive nuclear staining) on IHC
Exclusion Criteria:
* Prior neoadjuvant chemotherapy for current endometrial cancer diagnosis
* Prior pelvic radiation
* Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \>= 5 years
* Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)
* SUB-STUDY A: Isolated tumour cell(s) identified in lymph node(s) for patients in Cohort A1
* SUB-STUDY B: Abnormal p53 and/or mismatch repair deficiency on immunohistochemistry without pathogenic POLE mutation.
* Abnormal p53 can also be determined by TP53 mutations found on DNA testing.
* SUB-STUDY B: p53wt/NSMP endometrial carcinoma with a MELF (microcystic, elongated and fragmented) pattern of myoinvasion and/or substantial lymphovascular invasion
* SUB-STUDY B: Stage IA (not confined to polyp), grade 3, pN0, with substantial LVI. Stage IB, grade 1 or 2, pNx/N0, with substantial LVI
* SUB-STUDY B: Isolated tumour cell(s) identified in lymph node(s) OTHER: Clinical Observation, PROCEDURE: Computed Tomography, RADIATION: External Beam Radiation Therapy, PROCEDURE: High-Dose-Rate Vaginal Brachytherapy, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, OTHER: Questionnaire Administration, PROCEDURE: X-Ray Imaging
Stage I Uterine Corpus Endometrial Stromal Sarcoma AJCC v8, Stage II Uterine Corpus Endometrial Stromal Sarcoma AJCC v8, Stage III Uterine Corpus Endometrial Stromal Sarcoma AJCC v8
I'm interested
Share via email
Show 61 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (Roster@nrgoncology.org) |
| Duke University Medical Center Durham, North Carolina | |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Farmington Health Center Farmington, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| First Physicians Group-Sarasota Sarasota, Florida | |
| Florida Cancer Specialists - Sarasota Downtown Sarasota, Florida | |
| Florida Cancer Specialists - Venice Pinebrook Venice, Florida | Site Public Contact - (ClinicalTrials@FLCancer.com) |
| Grady Health System Atlanta, Georgia | |
| Huntington Memorial Hospital Pasadena, California | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Intermountain Health West End Clinic Billings, Montana | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson League City League City, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson West Houston Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in Sugar Land Sugar Land, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in The Woodlands Conroe, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Mount Sinai Chelsea New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Piedmont Hospital Atlanta, Georgia | Site Public Contact - (ORS@piedmont.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| Sarasota Memorial Health Care Center at University Parkway Sarasota, Florida | |
| Sarasota Memorial Hospital Sarasota, Florida | |
| Sarasota Memorial Hospital-Venice N. Venice, Florida | |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UMass Memorial Medical Center - Memorial Division Worcester, Massachusetts | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of Arizona Cancer Center-Orange Grove Campus Tucson, Arizona | |
| University of New Mexico Cancer Center Albuquerque, New Mexico | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Utah Sugarhouse Health Center Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| Upstate Cancer Center Radiation Oncology at Oswego Oswego, New York | Site Public Contact - (BinghamE@upstate.edu) |
| Upstate Cancer Center at Verona Verona, New York | Site Public Contact - (McDowelE@upstate.edu) |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Women and Infants Hospital Providence, Rhode Island |
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
ctrrecruit@vcu.edu
NCT05564390
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS.
* Participants must be \>= 18 years of age.
* Participants must not have received prior anti-cancer therapy for AML or MDS.
* Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.
* Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction.
* Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure.
* Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment.
* Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy
* Note: active hormonal therapy is allowed
* Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration.
* Participants must agree to have translational medicine specimens submitted.
* Participants must be offered the opportunity to participate in specimen banking.
* Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP.
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
* Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
* The master screening and reassessment protocol (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the site is willing to follow the MSRP Tier Advancement Pathway (TAP) for patients in the event that the site does not have the relevant study open and transfer to another site that does have the study open. For example, if a site does not have a myeloMATCH Tier 1 study for older AML open for enrollment, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of care on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to. PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation, DRUG: Azacitidine, OTHER: Best Practice, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Busulfan, PROCEDURE: Chest Radiography, PROCEDURE: Computed Tomography, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Decitabine and Cedazuridine, PROCEDURE: Echocardiography Test, BIOLOGICAL: Emavusertib, DRUG: Enasidenib, BIOLOGICAL: Epoetin Alfa, DRUG: Fludarabine, DRUG: Gemtuzumab Ozogamicin, DRUG: Gilteritinib, DRUG: Liposome-encapsulated Daunorubicin-Cytarabine, BIOLOGICAL: Luspatercept, DRUG: Melphalan, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mutation Carrier Screening, DRUG: Olutasidenib, DRUG: Placebo Administration, PROCEDURE: Positron Emission Tomography, RADIATION: Total-Body Irradiation, DRUG: Venetoclax
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm, Acute Myeloid Leukemia Post Cytotoxic Therapy, Acute Myeloid Leukemia, Myelodysplasia-Related, Myelodysplastic Syndrome
I'm interested
Share via email
Show 347 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate High Tech Medical Park Palos Heights, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Outpatient Center - Oak Lawn Oak Lawn, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | Site Public Contact - (ctsucontact@westat.com) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Ben Taub General Hospital Houston, Texas | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| CIUSSSEMTL-Hopital Maisonneuve-Rosemont Montreal, Quebec | |
| CSSS Champlain-Charles Le Moyne Greenfield Park, Quebec | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ctsucontact@westat.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| Edward Hines Jr VA Hospital Hines, Illinois | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Froedtert and MCW Moorland Reserve Health Center New Berlin, Wisconsin | |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| George E Wahlen Department of Veterans Affairs Medical Center Salt Lake City, Utah | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| HaysMed Hays, Kansas | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Schar Cancer Institute Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jewish General Hospital Montreal, Quebec | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Juravinski Cancer Centre at Hamilton Health Sciences Hamilton, Ontario | |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente- Modesto MOB II Modesto, California | |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana | |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lewistown Hospital Lewistown, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Loyola University Medical Center Maywood, Illinois | |
| MaineHealth Cancer Care and IV Therapy - Brunswick Brunswick, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital West Pembroke Pines, Florida | |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital South St Louis, Missouri | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin | Site Public Contact - (oncologyclinicaltrials@mhemail.org) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Miami Cancer Institute Miami, Florida | |
| Mid Coast Hospital Brunswick, Maine | Site Public Contact - (ctsucontact@westat.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monmouth Medical Center Long Branch, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| North Shore University Hospital Manhasset, New York | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Novant Health Forsyth Medical Center Winston-Salem, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health New Hanover Regional Medical Center Wilmington, North Carolina | |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| OSF Saint Francis Medical Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| OSF Saint Joseph Medical Center Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Our Lady of The Lake Baton Rouge, Louisiana | |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Phoebe Putney Memorial Hospital Albany, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| QEII Health Sciences Centre/Nova Scotia Health Authority Halifax, Nova Scotia | |
| Reading Hospital West Reading, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rhode Island Hospital Providence, Rhode Island | |
| Rochester General Hospital Rochester, New York | Site Public Contact - (tia.derosa@rochestergeneral.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Patrick Hospital - Community Hospital Missoula, Montana | Site Public Contact - (amy.hanneman@providence.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| San Juan City Hospital San Juan, | |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Iowa Clinic PC West Des Moines, Iowa | |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| The Valley Hospital - Luckow Pavilion Paramus, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Tibor Rubin VA Medical Center Long Beach, California | |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | Site Public Contact - (ucstudy@uci.edu) |
| UCSF Medical Center-Parnassus San Francisco, California | |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Pella Pella, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Clinical Research Center Fairway, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of Tennessee - Knoxville Knoxville, Tennessee | |
| University of Vermont Medical Center Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Health System Ridgewood Campus Ridgewood, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven, Connecticut | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Weisberg Cancer Treatment Center Farmington Hills, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| William S Middleton VA Medical Center Madison, Wisconsin | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease (AMPLITUDE)
Medical Information - medicalinfo@vrtx.com
NCT05312879
Show full eligibility criteria
Hide eligibility criteria
Key
Inclusion Criteria:
Part A:
* APOL1 genotype of G1/G1, G2/G2, or G1/G2
* Proteinuric kidney disease
Part B:
\- Completion of Treatment Period in Part A and no permanent discontinuation of study drug.
Key Exclusion Criteria:
Part A:
* Solid organ or bone marrow transplant
* Uncontrolled hypertension
* History of diabetes mellitus
* Known underlying cause of kidney disease including but not limited to sickle cell disease
Part B:
* ESKD (End Stage Kidney Disease) as defined in the protocol.
* Any lab abnormality that may pose a safety risk to the participant, as judged by the investigator.
Other protocol defined Inclusion/Exclusion criteria will apply. DRUG: VX-147, DRUG: Placebo
Proteinuric Kidney Disease
APOL1-mediated kidney disease (AMKD)
I'm interested
Share via email
Show 318 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center Ann Arbor, Michigan | |
| AA Medical Research Center Flint, Michigan | |
| AMR-Miami Coral Gables, Florida | |
| AURA Nord Saint-Ouen, | |
| Advanced Clinical Research of Atlanta Atlanta, Georgia | |
| Alabama Kidney Research Alabaster, Alabama | |
| Ambroise Paré Hospital Paris, | |
| American Clinical Trials LLC - Acworth Acworth, Georgia | |
| American Clinical Trials LLC - Douglasville Douglasville, Georgia | |
| Amicis Research Center - Balboa Granada Hills, California | |
| Amsterdam UMC - Amsterdam Public Health Research Institute Amsterdam, | |
| Ann & Robert H. Lurie Children's Hospital of Chicago - Nephrology Chicago, Illinois | |
| Arizona Kidney Disease and Hypertension Center - Banner Desert Office Mesa, Arizona | |
| Arizona Kidney Disease and Hypertension Center - Thomas Office Phoenix, Arizona | |
| Arlington Nephrology Arlington, Texas | |
| Atlanta VA Healthcare System Decatur, Georgia | |
| Augusta University Medical College of Georgia - Adult Sickle Cell Clinic Augusta, Georgia | |
| Barnes-Jewish Center for Outpatient Health St Louis, Missouri | |
| Barnum Medical Research - Bienville St Natchitoches, Louisiana | |
| Bay Pines Foundation Bay Pines, Florida | |
| Baylor Scott and White Research Institute - Nephrology Dallas, Texas | |
| Beth Israel Deaconess Medical Center - Nephrology Boston, Massachusetts | |
| Bicetre Hospital Le Kremlin-Bicêtre, | |
| Bioluminux Clinical Research New Jersey Hamilton, New Jersey | |
| Boston Medical Center Boston, Massachusetts | |
| Brookview Hills Research Associates Winston-Salem, North Carolina | |
| CHI St. Vincent Heart Clinic Arkansas- Cardiology and Medicine Clinic - Little Rock Little Rock, Arkansas | |
| CHU Dupuytren 2 - Néphrologie, dialyse, transplantations Limoges, | |
| CHU de Guadeloupe Pointe à Pitre, | |
| CNS Healthcare - Memphis Memphis, Tennessee | |
| CSB Group of Nephrology Brazil Salvador, | |
| CTR Oakwater, LLC Orlando, Florida | |
| CUH - Sheridan Pavilion - Three Cooper Plaza Camden, New Jersey | |
| Cardiology, P.C. Birmingham, Alabama | |
| Carolina Nephrology, PA Spartanburg, South Carolina | |
| Cedars-Sinai Medical Center Beverly Hills, California | |
| Center for Advanced Kidney Research Saint Clair Shores, Michigan | |
| Center for Specialized Medicine - Nephrology St Louis, Missouri | |
| Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS Cartagena, | |
| Centro de Pesquisa Clinica Professor Salomao Kelner Recife, | |
| Centro de Pesquisa Clinica do Coracao Aracaju, | |
| Children's Hospital of Alabama Birmingham, Alabama | |
| Children's Hospital of Pittsburgh - Nephrology Pittsburgh, Pennsylvania | |
| Children's National Hospital - Nephrology Washington D.C., District of Columbia | |
| Cincinnati VA Medical Center Cincinnati, Ohio | |
| Cleveland Clinic - Main Campus Cleveland, Ohio | |
| Clincept - Veterans Pkwy. Columbus, Georgia | |
| Clindove Research LLC Brooklyn, New York | |
| Clinica de La Costa S.A.S Atlántico, | |
| Clinical & Translational Science Unit (CTSU) - Nephrology Kansas City, Kansas | |
| Clinical Research Strategies - Romano North Main Office Houston, Texas | |
| Clinical Research of Brandon, LLC Brandon, Florida | |
| Cmip-Centro Mineiro de Pesquisa Ltda Juiz de Fora, | |
| Coastal Medical Research Brunswick, Georgia | |
| Columbia Nephrology Associates, PA Columbia, South Carolina | |
| Comlexo Hospitalar Universitário Professor Edgard Santos Salvador, | |
| Cook Children's Medical Center Fort Worth, Texas | |
| Cordova Research Institute Miami, Florida | |
| DaVita Kidney Care - Las Vegas Las Vegas, Nevada | |
| Dallas Nephrology Associates - Dallas Landry Office Dallas, Texas | |
| Dallas Renal Group - Liberty Dallas Dialysis Center Dallas, Texas | |
| Dallas Renal Group - Mansfield Arlington, Texas | |
| Dallas Renal Group- Dallas Dallas, Texas | |
| Davita Clinical Research - El Paso El Paso, Texas | |
| Delray Physician Care Center Delray Beach, Florida | |
| Dom Vicente Scherer Hospital Porto Alegre, | |
| Duke University Hospital - Children's Health Center Durham, North Carolina | |
| Eastern Nephrology Associates - Greenville Office Greenville, North Carolina | |
| Eastern Nephrology Associates - Jacksonville Office Jacksonville, North Carolina | |
| Eastern Nephrology Associates - Kinston Office Kinston, North Carolina | |
| Eastern Nephrology Associates - New Bern Office New Bern, North Carolina | |
| Eastern Nephrology Associates - Wilmington Office Wilmington, North Carolina | |
| Eastside Clinical Research Associates Los Angeles, California | |
| Edward Hines Jr VA Hospital Hines, Illinois | |
| Elixia Pines Hollywood, Florida | |
| Elixia Tampa Tampa, Florida | |
| EmVenio Research - Chicago Chicago, Illinois | |
| EmVenio Research - Mobile Unit - Birmingham Birmingham, Alabama | |
| Emory Childrens Center - Nephrology Atlanta, Georgia | |
| Emory School of Medicine - Renal Division Atlanta, Georgia | |
| Epsom and St Helier University Hospitals NHS Trust Carshalton, | |
| Essential Concepts Research Solutions Palos Hills, Illinois | |
| FDI Clinical Research San Juan, | |
| Faculdade de Medicina de Botucatu - CKD and Hypertension Department Botucatu, | |
| Faculdade de Medicina de Botucatu - Kidney Transplantation Department Botucatu, | |
| Federal University of Goiás (UFG) Goiânia, | |
| Fides Clinical Research Atlanta, Georgia | |
| Frenova-Southwest Houston Houston, Texas | |
| Fundacion Hospitalaria San Vicente de Paul Medellín, | |
| Fundación Valle Del Lili Cali, | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto, | |
| FutureMeds Birmingham Birmingham, | |
| G.V. (Sonny) Montgomery VAMC Jackson, Mississippi | |
| GCM Medical Group, PSC San Juan, | |
| Galileo Medical Research Ltda Juiz de Fora, | |
| General Nephrology Clinic - New York City New York, New York | |
| Genesis Clinical Research Tampa, Florida | |
| Georgia Nephrology - Decatur Decatur, Georgia | |
| Georgia Nephrology - Lawrenceville - Billing Office Lawrenceville, Georgia | |
| Great Ormond Street Hospital For Children London, | |
| Greater Hartford Nephrology Bloomfield, Connecticut | |
| Grossman School of Medicine New York, New York | |
| Guy's Hospital - Endocrinology London, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Heart Center Research LLC Huntsville, Alabama | |
| Helen Diller Medical Center at Parnassus Heights San Francisco, California | |
| Henry Ford Health System - Nephrology Detroit, Michigan | |
| Hopital Henri Mondor - Nephrology Créteil, | |
| Hopital Necker Enfants Malades - Nephrology Paris, | |
| Hopital Tenon Paris, | |
| Hopital de la Conception Marseille, | |
| Horizon Research Group - Coral Gables Coral Gables, Florida | |
| Hospital Ana Nery/SESAB Salvador, | |
| Hospital Clinic de Barcelona - Nephrology Barcelona, | |
| Hospital Curry Cabral - Serviço de Nefrologia Lisbon, | |
| Hospital Nord Michallon - Nephrology Grenoble, | |
| Hospital Nove de Julho - Nephrology São Paulo, | |
| Hospital São Lucas Rio de Janeiro, | |
| Hospital Universitari Vall d´Hebron - Servicio de Pediatria Barcelona, | |
| Hospital Universitario 12 de Octubre - Nephrology Madrid, | |
| Hospital Universitario Pedro Ernesto - Departamento de Nefrologia Rio de Janeiro, | |
| Hospital Universitario Pedro Ernesto - Departamento de Patologia Rio de Janeiro, | |
| Hospital Universitario Virgen Macarena Seville, | |
| Hospital das Clínicas da Faculdade de Medicina - Laboratório de Nefrologia Celular, Genética e Molecular São Paulo, | |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Ribeirão Preto, | |
| Hospital de Clínicas de Porto Alegre - Nephrology Porto Alegre, | |
| Hospital do Rim - Fundação Oswaldo Ramos São Paulo, | |
| Houston Medical Research Institute, LLC Houston, Texas | |
| Hôpital de Rangueil Toulouse, | |
| ICM - Instituto do Coração de Marília Marília, | |
| IPECC - Instituto de Pesquisa Clinica de Campinas Campinas, | |
| IU School of Medicine - Nephrology Indianapolis, Indiana | |
| Icahn School of Medicine at Mount Sinai - Nephrology New York, New York | |
| Infigo Clinical Research Sanford, Florida | |
| Inova Clinical Trials and Research Center Tyrone, Georgia | |
| Instituto Pro-Renal Curitiba, | |
| Instituto de Ensino e Pesquisa Clinica do Ceara Fortaleza, | |
| InterMed Consultants - Edina Clinic Edina, Minnesota | |
| Irmandade Da Santa Casa De Misericordia De Sao Paulo São Paulo, | |
| James J. Peters VA Medical Center The Bronx, New York | |
| Javara Inc./Privia Medical Group - Annapolis, MD Annapolis, Maryland | |
| Javara Inc./Privia Medical Group - Fayetteville, GA Fayetteville, Georgia | |
| Javara Inc./Privia Medical Group - Savannah, GA Savannah, Georgia | |
| Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike Silver Spring, Maryland | |
| Jefferson Einstein Philadelphia Hospital - Nephrology Philadelphia, Pennsylvania | |
| Jefferson Health - 33 South 9th Street Philadelphia, Pennsylvania | |
| Jersey Shore University Medical Center Neptune City, New Jersey | |
| Kaiser Permanente Georgia Atlanta, Georgia | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | |
| Kaiser Permanente Sacramento Medical Center Sacramento, California | |
| Kidney Care Center of North Valley Granada Hills, California | |
| Kidney Care and Transplant Services of New England - West Springfield West Springfield, Massachusetts | |
| Kidney Medical Associates, PLLC The Bronx, New York | |
| Kidney Specialists of N Houston, PLLC Shenandoah, Texas | |
| Kidney and Hypertension Center Victorville, California | |
| King's College Hospital - Pulmonology London, | |
| Kings County Hospital Brooklyn, New York | |
| Komfo Anokye Teaching Hospital - Nephrology Kumasi, | |
| LCMC Health Metairie, Louisiana | |
| Lagos State University Teaching Hospital Ikeja, | |
| Lagos University Teaching Hospital Idi Araba, | |
| Le Bonheur Children's Hospital - Outpatient Clinic Memphis, Tennessee | |
| Leicester General Hospital Leicester, | |
| Lewis Katz School of Medicine at Temple University - Section of Nephrology Philadelphia, Pennsylvania | |
| Lifespan Clinical Research Center East Providence, Rhode Island | |
| Louis Stokes Cleveland VA Medical Center Cleveland, Ohio | |
| Louisiana Clinical and Translational Science (LA CaTS) Center New Orleans, Louisiana | |
| Louisiana State University Health Shreveport Shreveport, Louisiana | |
| MD Medical Research Oxon Hill, Maryland | |
| Manchester Royal Infirmary - Endocrinology Manchester, | |
| McGuire Research Institute, Inc. (151) Richmond, Virginia | |
| MedBio Trials Miami, Florida | |
| Medical College of Wisconsin - Pulmonology Milwaukee, Wisconsin | |
| Medical University of South Carolina - Pulmonology Charleston, South Carolina | |
| Mediservis del Tolima IPS S.A.S. Ibague, | |
| Metrolina Nephrology Associates - Freedom Dr Charlotte, North Carolina | |
| Mid and South Essex Hospitals NHS Trust Basildon, | |
| Mid-Atlantic Permanente Research Institute Gaithersburg, Maryland | |
| Milwaukee Nephrologists - Wauwatosa Wauwatosa, Wisconsin | |
| Minneapolis VA Healthcare System Minneapolis, Minnesota | |
| Monroe Research, LLC West Monroe, Louisiana | |
| Montefiore Einstein - Albert Einstein College of Medicine The Bronx, New York | |
| Montefiore Einstein Hospital - Moses Campus The Bronx, New York | |
| Morehouse School of Medicine, Grady Memorial Hospital Atlanta, Georgia | |
| NANI Research LLC - Evergreen Park IL Evergreen Park, Illinois | |
| NANI Research LLC - Fort Wayne IN Fort Wayne, Indiana | |
| NTKDA Lewisville Lewisville, Texas | |
| NYC Health + Hospital/Harlem New York, New York | |
| Nashville General Hospital - Meharry Medical College - Nephrology Nashville, Tennessee | |
| Nashville VA Medical Center Nashville, Tennessee | |
| Nephrology & Hypertension Associates, PC Middlebury, Connecticut | |
| Nephrology Associates Fairhope, Alabama | |
| Nephrology Associates of Tidewater, LTD Virginia Beach, Virginia | |
| Nephrology Associates, P.C. - Columbus Columbus, Mississippi | |
| Nephrology Clinical Trials Center Nashville, Tennessee | |
| Nephrology Consultants, LLC Huntsville, Alabama | |
| Nephrology Physicians, LLC Mishawaka, Indiana | |
| Nephrology and Hypertension Associates - Tupelo Tupelo, Mississippi | |
| Nephrotex Research Group Dallas, Texas | |
| Nevada Kidney Disease and Hypertension Centers Las Vegas, Nevada | |
| New Mexico VA Healthcare System Albuquerque, New Mexico | |
| New York Presbyterian Queens Flushing, New York | |
| Nigerian Institute of Medical Research Lagos, | |
| North Carolina Nephrology P.A. - Cary Cary, North Carolina | |
| North Florida/South Georgia Veterans Health System Gainesville, Florida | |
| Northwest Louisiana Nephrology, LLC Shreveport, Louisiana | |
| Northwestern Medical Group Chicago, Illinois | |
| Nottingham University Hospitals - Children's Clinical Research Facility - Pulmonology Nottingham, | |
| Nova Clinical Research, LLC - Bradenton - 59th St Bradenton, Florida | |
| Ochsner Medical Center - New Orleans New Orleans, Louisiana | |
| Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit Columbus, Ohio | |
| Olive Branch Family Medical Center Olive Branch, Mississippi | |
| Omega Research Orlando, LLC - Mercy Dr Orlando, Florida | |
| PUC Trials - Unidade Epicenter Curitiba, | |
| Patient First Clinical Trials Lutherville, Maryland | |
| Pharmacorp Clinical Trials, Inc Charleston, South Carolina | |
| Phoenix Children's Hospital, Inc. - Nephrology Phoenix, Arizona | |
| Praxis Pesquisa Medica Santo André, | |
| Premier Clinical Research Overland Park, Kansas | |
| Prime Clinical Research - Mansfield - Regency Parkway Mansfield, Texas | |
| Prime Clinical Research Inc - Lewisville Lewisville, Texas | |
| Prime Health and Wellness Fayette, Mississippi | |
| Prolato Clinical Research Center - Kirby Dr Houston, Texas | |
| Promotora Medica Las Americas S.A. - Clinica Las Americas Medellín, | |
| QUEST Research Institute Farmington Hills, Michigan | |
| Queen Elizabeth Hospital Birmingham Birmingham, | |
| Qway Research Hialeah, Florida | |
| Randomize Now - College Park College Park, Georgia | |
| Recherche GCP Research Montreal, | |
| Reina Sofia University Hospital - Nephrology Córdoba, | |
| Renal Associates Columbus, Georgia | |
| Renal Associates of Alabama, LLC Montgomery, Alabama | |
| Renal Associates of Baton Rouge Baton Rouge, Louisiana | |
| Renal Medicine Associates Albuquerque, New Mexico | |
| Renal Research of Montgomery County, PLLC The Woodlands, Texas | |
| Renal and Transplant Associates of New England, PC Springfield, Massachusetts | |
| Ronald Ralph MD PA Houston, Texas | |
| Rophe Adult and Pediatric Medicine Union City, Georgia | |
| Royal Free Hospital - Nephrology London, | |
| Rutgers Doctors Office Center Newark, New Jersey | |
| SKY Integrative Medical Center Ridgeland, Mississippi | |
| SUNY Downstate Health Sciences University Brooklyn, New York | |
| San Antonio Kidney Disease Center Physicians Group - Medical Center San Antonio, Texas | |
| San Antonio Kidney Disease Center Physicians Group - Westover Hills San Antonio, Texas | |
| Santa Casa de Misericordia de Belo Horizonte Belo Horizonte, | |
| Scott Research, Inc. Laurelton, New York | |
| Shands Hospital - Nephrology Gainesville, Florida | |
| Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO Bogotá, | |
| South Florida Nephrology Research Coral Springs, Florida | |
| South Florida Research Miami Springs, Florida | |
| South Florida Research Institute Lauderdale Lakes, Florida | |
| Southeast Kidney Associates East Point, Georgia | |
| Southeast Renal Research Institute Chattanooga, Tennessee | |
| Southwest Family Medicine Associates (SFMA) - Dallas Dallas, Texas | |
| Sparrow Clinical Research Institute Lansing, Michigan | |
| St George's Hospital London - Nephrology London, | |
| St Pancras Clinical Research London, | |
| St. Clair Nephrology Research Roseville, Michigan | |
| St. Louis Children's Hospital - Nephrology St Louis, Missouri | |
| St. Louis Heart and Vascular, P.C. St Louis, Missouri | |
| Synexus Clinical Research - Atlanta (DRS) Atlanta, Georgia | |
| Synexus Clinical Research - Chicago (DRS) Chicago, Illinois | |
| Synexus Clinical Research - Glasgow (DRS) Bellshill, | |
| Synexus Clinical Research - Midlands (DRS) Birmingham, | |
| Synexus Clinical Research - NW Consortium Manchester (DRS) Manchester, | |
| Synexus Clinical Research - New York (DRS) New York, New York | |
| Synexus Clinical Research - Orlando Orlando, Florida | |
| Texas Tech University Health Sciences Center Lubbock, Texas | |
| The Bank Hospital Cantonments, | |
| The George Washington University - GW Medical Faculty Associates Washington D.C., District of Columbia | |
| The Johns Hopkins University - Johns Hopkins Hospital - Nephrology Baltimore, Maryland | |
| The Kirklin Clinic - Nephrology Birmingham, Alabama | |
| The Medical Research Group - Saint Agnes Medical Center Fresno, California | |
| The Rogosin Kidney Center New York, New York | |
| The Royal London Hospital - Nephrology London, | |
| Tidewater Kidney Specialists - Church St. Norfolk, Virginia | |
| Total Research Group, LLC Miami, Florida | |
| Tranquil Clinical Research Webster, Texas | |
| Tufts Medical Center Boston, Massachusetts | |
| UAMS Medical Center - Pulmonology Little Rock, Arkansas | |
| UC - DCI McMillan Research Unit Cincinnati, Ohio | |
| UCI Center for Clinical Research Orange, California | |
| UCLA Division of Nephrology Los Angeles, California | |
| UCLA Lundquist Institute at Harbor-UCLA Medical Center Torrance, California | |
| UChicago Medicine - Comer Children's Hospital Chicago, Illinois | |
| UF Health Cardiovascular Center - Jacksonville Jacksonville, Florida | |
| UH Cleveland Medical Center - Nephrology Cleveland, Ohio | |
| UMMC Grenada Hospital Grenada, Mississippi | |
| UNC Clinical and Translational Research Center Chapel Hill, North Carolina | |
| UTSW Medical Center - Nephrology Dallas, Texas | |
| UVA Health - Nephrology Clinical Research Center Charlottesville, Virginia | |
| UW Medical Center - Montlake - Nephrology Seattle, Washington | |
| Unidade Local de Saude Amadora/Sintra, E.P.E. Amadora, | |
| Unidade Local de Saúde de Loures-Odivelas, E.P.E. Loures, | |
| Unidade Local de Saúde de Santa Maria, E.P.E. - Nephrology Lisbon, | |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Pulmonology Leuven, | |
| Universite Catholique de Louvain - Pulmonology Woluwe-Saint-Lambert, Brussels Capital | |
| University College Hospital London, | |
| University Medical Center - New Orleans - Nephrology New Orleans, Louisiana | |
| University of Ghana Medical School - Nephrology Accra, | |
| University of Iowa Health Care Medical Center- Nephrology Iowa City, Iowa | |
| University of Maryland Medical Center - General Clinical Research Center Baltimore, Maryland | |
| University of Nigeria Teaching Hospital Enugu, | |
| University of Puerto Rico Rio Piedras, | |
| University of Texas Health Science Center - Nephrology San Antonio, Texas | |
| Université Paris-Descartes / Hôpital Européen Georges Pompidou Paris, | |
| VA New York Harbor Healthcare System New York, New York | |
| Velocity Clinical Research - Hallandale Beach Hallandale, Florida | |
| Veterans Affairs Medical Center - Washington D.C Washington D.C., District of Columbia | |
| Virginia Commonwealth University - Division of Nephrology Richmond, Virginia | |
| Walter Cantídio University Hospital Fortaleza, | |
| Whittier Street Health Center Roxbury, Massachusetts | |
| Women's College Hospital Toronto, | |
| Wythenshawe Hospital - Medicines Evaluation Unit Manchester, | |
| Yale University - Yale Nephrology Clinical Research Clinic New Haven, Connecticut | |
| York Clinical Research, LLC Norfolk, Virginia | |
| Zenos Clinical Research Dallas, Texas | |
| Zucker School of Medicine Great Neck, New York |
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
ctrrecruit@vcu.edu
NCT06203600
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Participants must have advanced or locally unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma
* Participants must have PD-L1 CPS (Combined Positive Score) ≥ 1. This test would have been performed as part of standard of care (SOC) pathology testing, using tissue obtained within two years prior to registration and collected prior to or after a frontline regimen
* Participants must have a histologically confirmed diagnosis of microsatellite stable (MSS) and HER2 negative gastric, gastroesophageal junction, or esophageal adenocarcinoma
* Participants must have documented unresectable and/or metastatic disease on CT or MRI imaging completed prior to registration. Imaging must have been completed within 28 days prior to registration for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form
* Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy. All treatment for brain metastases must have been completed at least 28 days prior to registration
* Participants must have disease progression or intolerance to frontline standard of care (SOC) chemotherapy plus either nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor. Peri-operative chemotherapy plus nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor will count as one line if disease progression occurs while on the therapy or within 6 months of completing the chemotherapy plus nivolumab or pembrolizumab or other PD-1/PD-L1 inhibitor cycle
* Participants must not have received more than one prior line of systemic therapy defined as chemotherapy plus either nivolumab, pembrolizumab, or any other PD-1 or PD-L1 inhibitor, in the stage IV or unresectable setting. Peri-operative or adjuvant nivoluamb or other PD-1/PD-L1 inhibitors would count as one prior line of systemic therapy if patients progressed while on nivolumab (or other PD-1/PD-L1 inhibitors) or within 6 months of stopping it
* Note: Radiation or any other regional therapy options done to address local residual disease or metastatic disease would not count as a line of therapy. Maintenance therapy with a different form of fluoropyrimidine (i.e. switching from capecitabine to fluorouracil \[5FU\]) would not count as another line of therapy
* Participants must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \< 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as long as there has been a washout period for corticosteroids of ≥ 7 days prior to registration
* Participants must not have prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agent including events like pneumonitis, myocarditis, renal failure, Guillain barre syndrome, or myasthenia gravis. Participants with endocrinopathy events leading or not to replacement steroids, thyroid hormone, insulin, or cortisol are eligible
* Participants must not have received a live attenuated vaccination within 28 days prior to registration
* Participants must not have had a major surgery within 28 days or subcutaneous venous access device placement within 7 days prior registration
* Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator. Any participants with postoperative bleeding complications or wound complications from a surgical procedure performed in the last eight weeks should be excluded
* Participants must not have plans to undergo elective or planned major surgery during the clinical trial
* Participants must not have active bleeding or prior history of gastrointestinal (GI) perforation, fistula or significant GI bleeding (requiring transfusion, endoscopic or surgical intervention) within 84 days prior to registration
* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, investigational agents, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
* Participants must not have a history of a grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
* Participants must not have a history of grade 3 or 4 immunotherapy related toxicities with the exception of hormonal abnormalities like thyroiditis or thyroid derangements
* Participants must be ≥ 18 years old
* Participants must have Zubrod Performance Status of 0-2
* Participants must have a complete medical history and physical exam within 28 days prior to registration
* Leukocytes ≥ 2 x 10\^3/uL (within 28 days prior to registration)
* Absolute neutrophil count ≥ 1.2 x 10\^3/uL (within 28 days prior to registration)
* Hemoglobin ≥ 9.0 g/dL (within 28 days prior to registration)
* Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration) (unless liver metastases are present, in which case they must be ≤ 5 x ULN)
* Participants must have a calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
* Participants' urinary protein must be ≤ 1+ on dipstick or routine urinalysis (UA) within 28 days of registration. Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria ≥ 2+, then a 24-hour urine is to be collected and demonstrate \< 1000 mg of protein in 24 hours to allow participation in the study
* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better
* Participants must have recovered to baseline or \< grade 2 CTCAE version (v) 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically stable on supportive therapy
* Participants must not have experienced arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to registration
* Participants must not have uncontrolled blood pressure within 28 days prior to registration as determined by the treating investigator
* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to registration
* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to registration, if indicated
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
* Participants must not have a history of inflammatory bowel disease, (including ulcerative colitis and Crohn's disease), symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and myasthenia gravis, multiple sclerosis). Note: Participants with Graves' disease will be allowed
* Participants must not have a history of pneumonitis that has required oral or IV steroids within the last 12 months prior to registration
* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
* Participants who can complete patient reported outcomes (FACT-Ga and PRO-CTCAE) questionnaires in English or Spanish must participate in the quality of life studies
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, DRUG: Paclitaxel, OTHER: Questionnaire Administration, BIOLOGICAL: Ramucirumab
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Metastatic Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Unresectable Esophageal Adenocarcinoma, Unresectable Gastric Adenocarcinoma, Unresectable Gastroesophageal Junction Adenocarcinoma
I'm interested
Share via email
Show 371 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| AdventHealth Orlando Apopka, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Annie Penn Memorial Hospital Reidsville, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Medford Hospital Medford, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Baptist Health Medical Center - Little Rock Little Rock, Arkansas | |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Ben Taub General Hospital Houston, Texas | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Broadlawns Medical Center Des Moines, Iowa | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (protocols@swog.org) |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont | |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Cone Health Cancer Center Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health Cancer Center at Alamance Regional Burlington, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health Cancer Center at Asheboro Asheboro, North Carolina | |
| Cone Health Cancer Center at Drawbridge Parkway Greensboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Cone Health MedCenter Asheboro Asheboro, North Carolina | Site Public Contact - (stacey.phelps@conehealth.com) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Emory Decatur Hospital Decatur, Georgia | Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org) |
| Emory Johns Creek Hospital Johns Creek, Georgia | Site Public Contact - (m.lisa.hwang@emory.edu) |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Englewood Hospital and Medical Center Englewood, New Jersey | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center-South University Clinic Fargo, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Farmington Health Center Farmington, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Geisinger Cancer Center Dickson City Dickson City, Pennsylvania | Site Public Contact - (hemoncctrials@geisinger.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Glens Falls Hospital Glens Falls, New York | |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| HaysMed Hays, Kansas | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Health Providence Novi Hospital Novi, Michigan | Site Public Contact - (kfife3@hfhs.org) |
| Henry Ford Health Providence Southfield Hospital Southfield, Michigan | Site Public Contact - (kfife3@hfhs.org) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Fairlane Dearborn, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Wyandotte Hospital Wyandotte, Michigan | Site Public Contact - (nhay@hfhs.org) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Illinois CancerCare - Washington Washington, Illinois | |
| Illinois CancerCare-Bloomington Bloomington, Illinois | |
| Illinois CancerCare-Canton Canton, Illinois | |
| Illinois CancerCare-Carthage Carthage, Illinois | |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | |
| Illinois CancerCare-Galesburg Galesburg, Illinois | |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | |
| Illinois CancerCare-Macomb Macomb, Illinois | |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | |
| Illinois CancerCare-Pekin Pekin, Illinois | |
| Illinois CancerCare-Peoria Peoria, Illinois | |
| Illinois CancerCare-Peru Peru, Illinois | |
| Illinois CancerCare-Princeton Princeton, Illinois | |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Integris Cancer Institute of Oklahoma Oklahoma City, Oklahoma | |
| Integris Southwest Medical Center Oklahoma City, Oklahoma | Site Public Contact - (ctsucontact@westat.com) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Cherry Hill Hospital Cherry Hill, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente South Bay Harbor City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente West Los Angeles Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente- Modesto MOB II Modesto, California | |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Baldwin Park Baldwin Park, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Irvine Irvine, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Ontario Ontario, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Riverside Riverside, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Keck Medicine of USC Koreatown Los Angeles, California | |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lancaster General Ann B Barshinger Cancer Institute Lancaster, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Lawrence Memorial Hospital Lawrence, Kansas | |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| Lovelace Medical Center-Saint Joseph Square Albuquerque, New Mexico | Site Public Contact - (ZPollock@salud.unm.edu) |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital North Colorado Springs, Colorado | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercyhealth Cancer Institute - Rockford Rockford, Illinois | Site Public Contact - (oncologyclinicaltrials@mhemail.org) |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Englewood, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northern Westchester Hospital Mount Kisco, New York | Site Public Contact - (AMellor@northwell.edu) |
| Northwell Health Cancer Institute at Huntington Greenlawn, New York | |
| Northwell Health Imbert Cancer Center Bay Shore, New York | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwest Cancer Center - Hobart Hobart, Indiana | |
| Northwest Cancer Center - Main Campus Crown Point, Indiana | |
| Northwest Cancer Center - Valparaiso Valparaiso, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Northwest Oncology LLC Dyer, Indiana | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ochsner Hematology Oncology North Shore - Covington (West Region) Covington, Louisiana | Site Public Contact - (Cheryl.kesler@ochsner.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma | |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Phelps Memorial Hospital Center Sleepy Hollow, New York | |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Premier Blood and Cancer Center Dayton, Ohio | |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Ralph H Johnson VA Medical Center Charleston, South Carolina | Site Public Contact - (ashley.salvo@va.gov) |
| Rapid City Regional Hospital Rapid City, South Dakota | Site Public Contact - (research@monument.health) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Catherine Hospital Indianapolis, Indiana | Site Public Contact - (protocols@swog.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Westerly Westerly, Rhode Island | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Southeastern Medical Oncology Center-Clinton Clinton, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Swedish Covenant Hospital Chicago, Illinois | |
| The Community Hospital Munster, Indiana | |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | Site Public Contact - (rohta@queens.org) |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (protocols@swog.org) |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | Site Public Contact - (trials@missioncancer.com) |
| UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania | |
| UPMC Cancer Center-Uniontown Uniontown, Pennsylvania | Site Public Contact - (protocols@swog.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center - New Castle New Castle, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC Western Maryland Cumberland, Maryland | |
| UPMC-Heritage Valley Health System Beaver Beaver, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| USC Norris Oncology/Hematology-Newport Beach Newport Beach, California | |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of Utah Sugarhouse Health Center Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| University of Vermont Medical Center Burlington, Vermont | |
| University of Vermont and State Agricultural College Burlington, Vermont | |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| William S Middleton VA Medical Center Madison, Wisconsin | |
| Women's Diagnostic Center - Munster Munster, Indiana | Site Public Contact - (mnicholson@comhs.org) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics (STOP PEDS RCT)
Erika Enright - eenright@uw.edu
NCT06654752
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Age
• For main cohort and non-HEMT cohort: age 6 to \<19 years
• For preschool cohort: age 3 to \<6 years
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• sweat chloride ≥ 60 mEq/liter
• two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability of participant to comply with the requirements of the study
• Highly Effective Modulator Therapy
• For main cohort and preschool cohort: Taking HEMT for at least 3 months at enrollment
• For non-HEMT cohort: not eligible for HEMT based on CFTR genotype or eligible but not taking for at least 3 months and no plans to start HEMT in the next year, and also not taking tezacaftor-ivacaftor or lumacaftor-ivacaftor for at least 3 months
• For main cohort and non-HEMT cohort: able to perform acceptable and reproducible spirometry
• For main cohort and non-HEMT cohort: ppFEV1 ≥ 50% predicted at enrollment based on the Global lung Initiative (GLI) reference equations
• Ability to receive text messages and access the internet
Exclusion Criteria:
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data
• Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their baseline state of health, per self-report
• Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical baseline, per self-report
• History of solid organ transplant
• History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment
• Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment
• Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment
• Treatment with chronic oral antibiotics other than azithromycin at enrollment
• Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollment
OTHER: Immediate Oral Antibiotics, OTHER: Tailored Treatment: Oral Antibiotics only if Additional Treatment needed
Cystic Fibrosis
cystic fibrosis, oral antibiotics, pulmonary exacerbation, pediatric
I'm interested
Share via email
Show 33 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University Chicago, Illinois | Mariah Flowers - (maflowers@luriechildrens.org) |
| Boston Children's Hospital & Harvard University Boston, Massachusetts | Ethan Ito - (ethan.ito@childrens.harvard.edu) |
| British Columbia Children's Hospital Vancouver, British Columbia | Madison Weir - (Madison.Weir@bcchr.ca) |
| Children's Healthcare of Atlanta & Emory University Atlanta, Georgia | Joy Dangerfield - (jdanger@emory.edu) |
| Children's Hospital of Colorado Aurora, Colorado | Mary Cross - (Mary.Cross@childrenscolorado.org) |
| Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic Los Angeles, California | Jared Lopez, BA - (jalopez@chla.usc.edu) |
| Children's Hospital of Philadelphia & University of Pennsylvania Philadelphia, Pennsylvania | Matthew Gari - (garim@chop.edu) Erin Donnelly - (donnellye4@chop.edu) |
| Children's Hospital of Pittsburgh of UPMC & University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Adrienne DeRicco, RN - (adrienne.dericco2@upmc.edu) |
| Children's Hospitals and Clinics of Minnesota Minneapolis, Minnesota | Danniella Balangoy - (Danniella.Balangoy@childrensmn.org) |
| Children's Mercy Hospital Kansas City, Missouri | Jana Lomonte - (jblomonte@cmh.edu) |
| Children's Wisconsin & Medical College of Wisconsin Milwaukee, Wisconsin | Laura Roth, CCRC - (lroth@mcw.edu) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Sharon Kadon, RN, BSN, CPN - (sharon.kadon@cchmc.org) |
| Johns Hopkins Hospital, Johns Hopkins University Baltimore, Maryland | Jamelia Maynard - (jmaynar8@jhmi.edu) |
| Medical University of South Carolina Charleston, South Carolina | Audra Wiser - (wisera@musc.edu) |
| Oregon Health & Science University Portland, Oregon | Pierce Nusbaum - (nusbaum@ohsu.edu) |
| Rady Children's Hospital at University of California San Diego San Diego, California | Lisa Ramos, CRC - (lramosvallejo@health.ucsd.edu) |
| Riley Hospital for Children & Indiana University Indianapolis, Indiana | Misty Thompson - (misthomp@iu.edu) Lisa Bendy - (lbendy@iu.edu) |
| Seattle Children's Hospital Seattle, Washington | Mey Lee - (mey.lee@seattlechildrens.org) |
| St. Louis Children's Hospital & Washington University School of Medicine St Louis, Missouri | Emily Schulte, RN, BSN - (e.burns@wustl.edu) |
| Stanford University Palo Alto, California | Tina Conti, BSRC, RRT, RRT-NPS, C-NPT - (tconti@stanford.edu) |
| Texas Children's Hospital & Baylor College of Medicine Houston, Texas | Pavel Tuekam - (OrnellaPavel.TuekamMeko@bcm.edu) |
| The Children's Hospital Alabama & University of Alabama at Birmingham Birmingham, Alabama | Ashlyn Hastings - (aehastings@uabmc.edu) |
| The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics Toronto, Ontario | Claire Crompton - (claire.crompton@sickkids.ca) |
| The Minnesota Cystic Fibrosis Center & University of Minnesota Minneapolis, Minnesota | Alyssa Perry - (ahperry@umn.edu) |
| Tucson Cystic Fibrosis Center Tucson, Arizona | Elizabeth (Lisa) Ryan - (elizabethryan@arizona.edu) |
| University of Iowa Iowa City, Iowa | Mary Teresi - (mary-teresi@uiowa.edu) |
| University of Michigan Health System Ann Arbor, Michigan | Dawn Kruse - (dmkruse@med.umich.edu) |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | Caroline Flowers, CRC - (caroline_flowers@med.unc.edu) |
| University of Rochester Medical Center Strong Memorial Rochester, New York | Barbara Johnson, RN - (Barbara_johnson@urmc.rochester.edu) Karen McCarthy - (karen_mccarthy@urmc.rochester.edu) |
| University of Texas Southwestern & Children's Health Dallas, Texas | Lindsay Allen, CRC - (Lindsay.Allen@utsouthwestern.edu) |
| University of Wisconsin Madison, Wisconsin | Melanie Nelson, BS, RRT, CCRC - (mmnelson@medicine.wisc.edu) |
| Vermont Children's Hospital & University of Vermont Medical Center Burlington, Vermont | Vanessa Marascio - (Vanessa.Marascio@uvmhealth.org) |
| Virginia Commonwealth University Richmond, Virginia | Akilah Pierre-Louis, CRC - (Akilah.PierreLouis1@vcuhealth.org) |
Parkinson's Foundation PD GENEration Genetic Registry
Kamalini Ghosh, MS - kghosh@parkinson.org
NCT04994015
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Study Population 1: PWP (open for recruitment)
• Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.
• Willingness to undergo genetic testing, and choose to be informed of genetic testing results for GBA, LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
• Capacity to give full informed consent in writing or electronically, and have read and signed the informed consent forms (ICFs) based on site clinician's determination.
• Able to perform study activities (including completion of either online, in-person or paper surveys). Study Population 2: People at risk of developing PD (not open for recruitment)
• Family members of Study Population 1 may be invited to participate in the study if confirmatory genetic testing is deemed necessary by the genetic testing laboratory.
Exclusion Criteria:
• Diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus.
• Individuals who have received a blood transfusion within the past 3 months.
• Individuals who have active hematologic malignancies such as lymphoma or leukemia.
• Individuals who have had a bone marrow transplant within the past 5 years.
• Under the age of 18
DEVICE: Lab Assay for seven genetic variants for Parkinson's Disease
Parkinson's Disease
Genetics, Genetic Counseling, Whole Genome Sequencing
I'm interested
Share via email
Show 56 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Atrium Health Charlotte, North Carolina | Gina M'Buyamba - (gina.mbuyamba@atriumhealth.org) |
| Aventura Neurology - Visionary Investigators Network Aventura, Florida | Nicole Rios - (nrios@vintrials.com) |
| BMC Community Hospital Boston, Massachusetts | Madhuri Sangam - (Madhuri.Sangam@bmc.org) |
| Barrow Neurological Institute Phoenix, Arizona | Caitlin Goodman - (caitlin.goodman@commonspirit.org) |
| Baylor College of Medicine Houston, Texas | Silvia Onofre - (silvia.onofre@bcm.edu) |
| Beth Israel Deaconess Medical Center (BIDMC) Boston, Massachusetts | Jacqueline Forbes - (jforbes1@bidmc.harvard.edu) |
| Case Western Reserve University Cleveland, Ohio | Eileen Terrell - (eileen.terrell@UHhospitals.org) |
| Cleveland Clinic Cleveland, Ohio | Jerrod Cook - (cookj6@ccf.org) |
| Cleveland Clinic Weston Weston, Florida | Laura Duarte - (duartel2@ccf.org) |
| Columbia University New York, New York | Alexander Haimovich - (ah3912@cumc.columbia.edu) |
| Evergreen Health Kirkland, Washington | Nasir Hemat - (nahemat@evergreenhealthcare.org) |
| Hartford Healthcare Hartford, Connecticut | Brandon Canty - (brandon.canty@hhchealth.org) |
| Indiana University Indianapolis, Indiana | Lauren Perrey-Moore - (lperrey@iupui.edu) |
| Inland Northwest Research Spokane, Washington | Amanda Kiefer - (akiefer@inwresearch.com) |
| Intermountain Health Murray, Utah | Nic Unsworth - (Nic.Unsworth@imail.org) |
| Johns Hopkins Baltimore, Maryland | Ebubechukwu Onyinanya - (eonyina1@jhu.edu) |
| Louisiana State University Shreveport, Louisiana | Mackenzie Williams - (mackenzie.williams@lsuhs.edu) |
| MD First Research Chandler, Arizona | |
| Massachusetts General Hospital (MGH) Boston, Massachusetts | Vanessa Ibrahim - (vibrahim@mgh.harvard.edu) |
| Medical College of Wisconsin Milwaukee, Wisconsin | Jordan Bayola - (jbayola@mcw.edu) |
| Medical University of South Carolina Charleston, South Carolina | Sandra Wilson - (wilsosan@musc.edu) |
| Morehouse College Atlanta, Georgia | Tamiko Durham - (tdurham@msm.edu) |
| Mount Sinai New York, New York | Maya Rawal - (maya.rawal@mountsinai.org) |
| New York University New York, New York | Kelly Astudillo - (kelly.astudillo@nyulangone.org) |
| Northwestern University Chicago, Illinois | Rachel Leewandowski - (rachel.lewandowski@northwestern.edu) |
| Ohio State University Columbus, Ohio | Kate Ambrogi - (katherine.ambrogi@osumc.edu) |
| Oregon Health and Science University Portland, Oregon | Emily Leonard - (leonarde@ohsu.edu) |
| Parkinson's Disease & Movement Disorder Center of Boca Raton Boca Raton, Florida | Karla Arias - (karias@parkinsonscenter.org) Karina Weldon - (kweldon@parkinsonscenter.org) |
| Rush University Chicago, Illinois | Nathan Krinickas - (Nathan_Krinickas@rush.edu) Jacqueline Vanegas - (Jacqueline_Vanegas@rush.edu) |
| Rutgers University New Brunswick, New Jersey | Edward Scot Stenroos, MD - (stenroos@rwjms.rutgers.edu) |
| Struthers Parkinson's Center - HealthPartners Park Nicollet Golden Valley, Minnesota | Taylor Billeadeau - (Taylor.R.Billeadeau@HealthPartners.Com) |
| Tel Aviv Sourasky Medical Center Tel Aviv, | Roni Cohen - (ronicohen@tlvmc.gov.il) |
| The Queen's Health System Honolulu, Hawaii | Malika Faouzi - (mfaouzi@queens.org) |
| Thomas Jefferson University Philadelphia, Pennsylvania | Michelle Roachman - (michelle.roachman@jefferson.edu) |
| Toronto Western Hospital Toronto, Ontario | Nazish Ahmed - (nazish.ahmed@uhnresearch.ca) |
| University of Alabama Birmingham Birmingham, Alabama | Fariba Rahimi - (faribarahimi@uabmc.edu) |
| University of Arkansas Little Rock, Arkansas | Kennetha Newman - (newmankennethal@uams.edu) |
| University of California Los Angeles Los Angeles, California | Alexandra Shurlock - (Ashurlock@mednet.ucla.edu) |
| University of California San Diego (UCSD) La Jolla, California | Lisa Solomon - (ldamron@health.ucsd.edu) |
| University of California San Francisco (UCSF) San Francisco, California | Aaron Daley - (aaron.daley@ucsf.edu) |
| University of Chicago Chicago, Illinois | Tomas Mercado - (tmercado@bsd.uchicago.edu) |
| University of Cincinnati Cincinnati, Ohio | Kelly DeLano - (delanoky@ucmail.uc.edu) |
| University of Colorado Anschutz Aurora, Colorado | Janet Clarke - (janet.clarke@cuanschutz.edu) |
| University of Florida Gainesville, Florida | Amanda Fessenden - (amanda.fessenden@neurology.ufl.edu) |
| University of Illinois-Chicago Chicago, Illinois | Vijay Palakuzhy - (vpalakz@uic.edu) |
| University of Iowa Iowa City, Iowa | Heena Olalde - (heena-olalde@uiowa.edu) |
| University of Kansas Kansas City, Kansas | April Langhammerr - (alanghammer@kumc.edu) |
| University of Kentucky Lexington, Kentucky | Renee Wagner - (rpwagn2@uky.edu) |
| University of Maryland Baltimore, Maryland | Rebecca Weimer - (rweimer@som.umaryland.edu) |
| University of Miami Miami, Florida | Oriana Tarabay - (oxt185@med.miami.edu) |
| University of New Mexico Albuquerque, New Mexico | Anna Tingin - (ATingin@salud.unm.edu) |
| University of North Carolina - Chapel Hill Chapel Hill, North Carolina | Hans Nettescheim - (Hans_Nettesheim@med.unc.edu) |
| University of Pennsylvania Philadelphia, Pennsylvania | Neda Almassi - (Neda.Almassi@pennmedicine.upenn.edu) |
| University of Texas at San Antonio San Antonio, Texas | Carolyn Paiz - (paizc@uthscsa.edu) Omalys Biggs Rodriguez - (biggsrodrigu@uthscsa.edu) |
| Vanderbilt University Nashville, Tennessee | Jacqueline Harris - (jacqueline.c.harris@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | Virginia Norris - (virginia.norris@vcuhealth.org) |
A Study of Emapalumab for Pediatric Aplastic Anemia
Andromachi Scaradavou, MD - ScaradaA@mskcc.org
NCT06430788
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Patients undergoing workup for suspected newly diagnosed sAA:
* Patients with severe cytopenias and a hypocellular marrow concerning for sAA
* Patients that meet the definition for suspected sAA (Camitta Criteria) as follows:
Marrow Cellularity: \<25%, or 25-50% with \<30% residual hematopoietic cells Peripheral cytopenias (at least 2 of 3) Absolute neutrophil count (ANC): \<500 x 10\^9/L Platelets: \<20 x 10\^9/L Absolute Reticulocyte Count: \<60 x 10\^9/L
* Patients that do not have evidence of leukemia or MDS
* Patients \< 25 years of age at time of diagnosis
* Able to tolerate emapalumab and IST (with standard institutional organ function criteria)
Exclusion Criteria:
* Uncontrolled infection at presentation.
* Patients who have undergone previous treatment for sAA.
* Patients with known inherited bone marrow failure
* Patient who has completed a full workup for sAA including having results back from telomere testing, DEB and genetics (when applicable), as well as having an appropriate willing and available donor and would otherwise be admitted for HSCT within 2 weeks of enrolling on the trial
* Patients with leukemia or MDS
* Patient or parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests. BIOLOGICAL: Emapalumab
Aplastic Anemia, Cytopenia, Hypocellular Marrow
pediatric aplastic anemia, aplastic anemia, cytopenia, hypocellular marrow, Emapalumab, Memorial Sloan Kettering Cancer Center, 23-278
I'm interested
Share via email
Show 6 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Children's Hospital of Philadelphia (Data Collection AND Specimen Analysis) Philadelphia, Pennsylvania | |
| Children's Hospital of Wisconsin (Data Collection Only) Milwaukee, Wisconsin | |
| Cincinnati Children's Hospital Medical Center (Data collection only) Cincinnati, Ohio | Anthony Sabulski, MD - (anthony.sabulski@cchmc.org) |
| Medical College of Wisconsin (Data Collection AND Data Analysis) Milwaukee, Wisconsin | |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York, New York | |
| Virginia Commonwealth University (Data Collection Only ) Richmond, Virginia |
Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma
Stephen Simko, MD - clinicaltrials@lyell.com
NCT05826535
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Age 18 years or older
• Willing and able to provide written informed consent
• Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022)
• Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3
• Relapsed or refractory disease.
• At least 1 measurable lesion (per Lugano classification)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)
• Absolute neutrophil count (ANC) ≥ 1000/µL
• Platelet count ≥ 50,000/µL
• Absolute lymphocyte count (ALC) ≥ 200/µL Other protocol-defined criteria apply.
Exclusion Criteria:
• History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years
• Active central nervous system involvement
• History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
• Ongoing or impending oncologic emergency
• Recent systemic anti-cancer therapy or radiation
• Ongoing non-hematologic toxicities due to prior therapy
• History of allogeneic stem cell or solid organ transplantation
• Autologous stem cell transplantation within 6 weeks
• History of prior genetically modified cell therapy (Cohorts 1, 3, 4, 5) or no other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel) (Cohort 2).
• Primary immunodeficiency
• History of autoimmune disease resulting in end organ injury or requiring recent therapy Other protocol-defined criteria apply.
DRUG: Rondecabtagene autoleucel (ronde-cel), DRUG: Fludarabine, DRUG: Cyclophosphamide
Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Large B-cell Lymphoma
CAR T-cell, Non-Hodgkin Lymphoma, CD19/20, CD19, CD20, NHL, Diffuse Large B-cell lymphoma, DLBCL, Transformed follicular lymphoma, TFL, Primary mediastinal B-cell lymphoma, PMBCL, Follicular lymphoma Grade 3B, Large cell follicular lymphoma, Aggressive B-cell NHL, Refractory Aggressive B-Cell Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Cyclophosphamide, Fludarabine, Lymphoma, Follicular, Lymphoma, B-cell, Immunosuppressive Agents, Immunologic Factors, Disease Attributes, Immune System Diseases, Recurrence, PiNACLE
I'm interested
Share via email
Show 31 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Atrium Health Wake Forest Baptist Winston-Salem, North Carolina | |
| Augusta University Medical Center Augusta, Georgia | |
| Baylor University Medical Center Dallas, Texas | |
| Cedars-Sinai Medical Center Beverly Hills, California | |
| Cleveland Clinic Cleveland, Ohio | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Corewell Health Grand Rapids, Michigan | |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center New York, New York | |
| Huntsman Cancer Institute Salt Lake City, Utah | |
| Indiana Blood and Marrow Transplantation Indianapolis, Indiana | |
| Intermountain Healthcare Salt Lake City, Utah | |
| Lehigh Valley Topper Cancer Center Institute Allentown, Pennsylvania | |
| Louisiana State University Health Sciences Center Shreveport, Louisiana | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Montefiore Medical Center The Bronx, New York | |
| Roswell Park Comprehensive Cancer Center Buffalo, New York | |
| Scripps Clinic San Diego, California | |
| Texas Transplant Institute San Antonio, Texas | |
| The Alfred Hospital Melbourne, Victoria | |
| Thomas Jefferson University Philadelphia, Pennsylvania | |
| University of California, Los Angeles (UCLA) Medical Center Los Angeles, California | |
| University of California-Irvine Medical Center Irvine, California | |
| University of Cincinnati (UC) Physicians Company, LLC Cincinnati, Ohio | |
| University of Iowa Iowa City, Iowa | |
| University of Louisville Brown Cancer Center Louisville, Kentucky | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of New Mexico Comprehensive Cancer Center Albuquerque, New Mexico | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Virginia Commonwealth University-Massey Cancer Center Richmond, Virginia | |
| Virginia Oncology Associates Norfolk, Virginia | |
| West Penn Hospital Pittsburgh, Pennsylvania |
Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial
ctrrecruit@vcu.edu
NCT05886036
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Histopathologically confirmed diagnosis of NLPHL as confirmed by local pathologist's expert review.
* Untreated NLPHL: stage IB to IV according to Cotswolds. The proportion of patients with stages I or II treated with consolidative radiotherapy will be capped at 40%.
* Previously treated NLPHL, any stage.
* According to the treating physician, the patient should not be observed and needs therapy, notably because of B-symptoms (unexplained fever \[temperature \> 38 degrees Celsius (\> 100.4 degrees Fahrenheit)\], weight loss \[unexplained loss of \> 10 percent of body weight over the past six months\], or drenching night sweats), symptomatic nodal or extranodal disease, or patient preferences.
* Patients must have measurable disease according to the Lugano/Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) classification.
* Age \>= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of mosunetuzumab in patients \< 18 years of age, children are excluded from this study.
* Eastern Cooperative Oncology Group performance status =\< 2 (Karnofsky \>= 60%).
* Absolute neutrophil count \>= 1,000/mcL.
* Platelets \>= 100,000/mcL.
* Total bilirubin =\< 1.5 institutional upper limit of normal (ULN), except in patients with Gilbert's syndrome as defined by \> 80% unconjugated bilirubin.
* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine transaminase (ALT)(serum glutamic-pyruvic transaminase \[SGPT\]) =\< 3 x institutional ULN.
* Glomerular filtration rate (GFR) \>= 40mL /min= GFR (mL/Min/1.73 m\^2) \* body surface area (BSA)/1.73.
* Human immunodeficiency virus-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
* The effects of mosunetuzumab on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal and/or barrier method of birth control; abstinence) (both hormonal and barrier method of birth control are required for participants in Canada) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of mosunetuzumab administration and 12 months after completion of rituximab administration.
* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion Criteria:
* Classical Hodgkin lymphoma (cHL) or composite lymphoma.
* Transformed NLPHL, concerns of the treating physician of an occult transformation or concerns of the treating physician that the patient needs cytotoxic therapy.
* NLPHL relapse less than 6 months after rituximab or rituximab-containing therapy.
* Patients who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia.
* Patients who are receiving any other investigational agents.
* Patients with central nervous system (CNS) involvement as a result of lymphoma.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to mosunetuzumab or rituximab.
* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.
* Pregnant women are excluded from this study because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with mosunetuzumab; breastfeeding should be discontinued if the mother is treated with mosunetuzumab or rituximab. These potential risks may also apply to other agents used in this study.
* Prior allogeneic stem cell or solid organ transplantation.
* Participants who have received a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live, attenuated vaccine will be required during the study. Participants must not receive live, attenuated vaccines (e.g., FluMist \[registered trademark\]) while receiving study treatment and after the last dose until B-cell recovery to the normal ranges. Killed vaccines or toxoids should be given at least 4 weeks prior to the first dose of study treatment to allow development of sufficient immunity.
* Any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment.
* Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results as judged by the investigator, including, but not limited to:
* Significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina).
* Significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm).
* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
* Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed.
* Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible only for the expansion cohort.
* History of confirmed progressive multifocal leukoencephalopathy (PML).
* Participants with infections requiring IV treatment with antibiotics or hospitalization (grade 3 or 4) within the last 4 weeks prior to enrollment or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment.
* Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to first dose of study treatment.
* Known or suspected chronic active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection.
* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH). PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, OTHER: Fludeoxyglucose F-18, BIOLOGICAL: Mosunetuzumab, PROCEDURE: Positron Emission Tomography, BIOLOGICAL: Rituximab, BIOLOGICAL: Rituximab and Hyaluronidase Human
Nodular Lymphocyte Predominant B-Cell Lymphoma, Recurrent Nodular Lymphocyte Predominant B-Cell Lymphoma, Refractory Nodular Lymphocyte Predominant B-Cell Lymphoma
I'm interested
Share via email
Show 35 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Springs Coral Springs, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Doral Doral, Florida | Site Public Contact - (kginnity@med.miami.edu) |
| UM Sylvester Comprehensive Cancer Center at Hollywood Hollywood, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center at North Kansas City Hospital North Kansas City, Missouri | |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina |
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis (AFFIRM)
Gilead Clinical Study Information Center - GileadClinicalTrials@gilead.com
NCT06051617
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Individuals must meet the following criteria to be eligible for study participation:
• Must be at least 18 years old.
• Must have a confirmed prior diagnosis of PBC
• Evidence of cirrhosis
• CP Score A or B
• Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
• Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)
Exclusion Criteria:
Individuals must not meet any of the following criteria to be eligible for study participation:
• Prior exposure to seladelpar
• A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
• History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
• Decompensated cirrhosis
• Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
• Hospitalization for liver-related complication within 12 weeks of Screening
• Laboratory parameters at Screening:
• Alkaline phosphatase (ALP) \< 1.5× Upper limit of normal (ULN) or ≥ 10×ULN
• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN
• Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN
• Platelet count ≤50×10\^3/µL
• Albumin ≤2.8 g/dL
• Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m\^2
• MELD score \>12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.
• Serum alpha-fetoprotein (AFP) \>20 ng/mL
• INR \>1.7
• CP-C cirrhosis
• History or presence of other concomitant liver diseases
DRUG: Seladelpar, DRUG: Placebo
Primary Biliary Cholangitis
Primary Biliary Cholangitis (PBC), PBC
I'm interested
Share via email
Show 191 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| A.O.U. Pisana, U.O. Epatologia Pisa, | |
| A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia Palermo, | |
| AES - AS - Glenny Corp. S.A. Buenos Aires Buenos Aires, | |
| AP-HP Hopital Henri Mondor Paris, | |
| ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e Gastroenterologico Milan, | |
| Aarhus Universitetshospital Aarhus N, Central Jutland | |
| Adana City Training and Research Hospital Adana, | |
| Alfred Hospital Melbourne, Victoria | |
| American Research Corporation San Antonio, Texas | |
| Ankara Bilkent City Hospital Ankara, | |
| Asan Medical Center Seoul, | |
| Azienda Ospedaliero Universitaria delle Marche -Umberto I G.M. Lancisi G. Salesi Ancona, | |
| Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara Modena, | |
| Beijing Ditan Hospital, Capital Medical University Beijing, | |
| Beijing Friendship Hospital, Capital Medical University Beijing, | |
| Beijing Youan Hospital, Capital Medical University Beijing, | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Biocinetic Ltda Santiago, | |
| Buenos Aires Mácula Buenos Aires, | |
| C.H. Regional Reina Sofia - PPDS Córdoba, | |
| CHRU de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy, | |
| CHU de Strasbourg - Nouvel Hôpital Civil Strasbourg, | |
| CHU-Montpellier-Hopital St Eloi Montipellier, | |
| CINME S.A. - Centro de Investigaciones Metabólicas Recoleta, | |
| California Liver Research Institute Pasadena, California | |
| California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco, California | |
| Cedar Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier de l'Université de Montréal Montreal, Quebec | |
| Centro De Investigacion Y Gastroenterogia, S.C. México, | |
| Centro de Investigación y Prevención Cardiovascular La Serena, | |
| Centro de Investigación y Prevención Cardiovascular La Serena, | |
| Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital Kaohsiung City, | |
| Chang Gung Memorial Hospital, Linkou Taoyuan, | |
| Changi General Hospital Singapore, | |
| Charité Campus Virchow-Klinikum-Augustenburger Platz 1 Berlin, | |
| Chonnam National University Hospital Gwangju, | |
| Clinica de Higado y Gastroenterologia Integral, S.C. Cuernavaca, | |
| Clinical Research Chile SpA - PPDS Valdivia, | |
| Complexo Hospitalario Universitario De Santiago Santiago de Compostela, | |
| Connie Frank Transplant Center at UCSF San Francisco, California | |
| Consultorio Medico - Distrito Federal Mexico City, | |
| Consultorios Médicos Dr. Doreski - PPDS Buenos Aires, | |
| Covenant Metabolic Specialists, LLC Sarasota, Florida | |
| Covenant Metabolic Specialists, LLC Sarasota, Florida | |
| DIM Clinica Privada Buenos Aires, | |
| Diex Recherche - Québec - PPDS Québec, | |
| East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital Ipswich, | |
| Ege University Izmir, | |
| Evangelismos General Hospital Athens, | |
| FAICIC Veracruz, | |
| Fakultni Nemocnice Ostrava Ostrava, | |
| Flinders Medical Center Adelaide, South Australia | |
| Florida Research Institute Tampa, Florida | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, | |
| Fondazione IRCCS San Gerardo dei Tintori Monza, | |
| Freeman Hospital Newcastle upon Tyne, | |
| GI Research Institute Foundation Vancouver, | |
| Gastro One Cordova, Tennessee | |
| Gastroenterologisch - Hepatologisches MVZ Kiel GmbH Kiel, | |
| Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital Gaziantep, | |
| General Hospital of Thessaloniki ''Hippokratio'' Thessaloniki, | |
| Guizhou Provincial People's Hospital Guiyang, | |
| Henan provincial people's hospital Zhengzhou, | |
| Henry Ford Medical Center - Columbus Detroit, Michigan | |
| Higea S.A. Mendoza, | |
| Hopital Saint Antoine, Assistance Publique-Hopitaux de Paris Paris, | |
| Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse Lyon, | |
| Hospital Clinic de Barcelona Barcelona, | |
| Hospital Del Mar Barcelona, | |
| Hospital Provincial del Centenario Rosario, | |
| Hospital Universitario Fundacion Alcorcon Alcorcón, | |
| Hospital Universitario Germans Trias i Pujol Badalona, | |
| Hospital Universitario Marqués de Valdecilla Santander, | |
| Hospital Universitario Vall d'Hebron-VIHR Barcelona, | |
| Hospital Universitario Virgen de la Victoria Málaga, | |
| Hospital Universitario Virgen del Rocio - PPDS Seville, | |
| Hull Royal Infirmary Hull, | |
| Hôpital Claude Huriez-Lille-1 Place de Verdun Lille, | |
| ID Clinic Arkadiusz Pisula Myslowice, Lesser Poland Voivodeship | |
| IRCCS Saverio de Bellis-UOSD "Epatopatie" Castellana Grotte, | |
| Institutul Clinic Fundeni Bucharest, | |
| John Radcliffe Hospital Oxford, | |
| Kaohsiung Medical University Hospital Kaohsiung City, | |
| Katip Celebi University Karabağlar, | |
| King's College Hospital London, | |
| Klinikum Wels-Grieskirchen GmbH - Standort Wels Wels, | |
| Kocaeli University Medical Faculty Hospital Kocaeli, | |
| Korea University Guro Hospital Seoul, | |
| Krankenhaus der Barmherzigen Brüder Vienna, | |
| Kyungpook National University Hospital Daegu, | |
| Lady Davis Carmel Medical Center Haifa, | |
| Landeskrankenhaus Hall Hall in Tirol, | |
| Liver Institute Northwest Seattle, Washington | |
| Liver Unit, institute of Gasteroenterology and Liver Diseases Jerusalem, | |
| Marmara University Pendik Training and Research Hospital Istanbul, | |
| Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads Newport News, Virginia | |
| Massachusetts General Hospital Boston, Massachusetts | |
| MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax Fairfax, Virginia | |
| Medical University of South Carolina Charleston, South Carolina | |
| Medizinische Universität Wien Vienna, | |
| Mengchao Hepatobiliary Hospital of Fujian Medical University Fuzhou, | |
| Mercy Medical Center Rockville Centre, New York | |
| Mersin Universitesi Tip Fakultesi Hastanesi Mersin, | |
| Monash Health, Monash Medical Centre Clayton, Victoria | |
| Mount Sinai New York, New York | |
| NYU Langone Health New York, New York | |
| National Cheng Kung University Hospital Tainan, | |
| National Taiwan University Hospital Taipei, | |
| National University Hospital Singapore, | |
| New Cross Hospital Wolverhampton, | |
| Northern Health Epping, Victoria | |
| Northwell Health Center for Liver Disease and Transplantation Manhasset, New York | |
| Northwestern University Chicago, Illinois | |
| Oaxaca Site Management Organization - Hospital - OSMO - PPDS Oaxaca City, | |
| Ochsner Clinic Foundation New Orleans, Louisiana | |
| Om Research LLC Oxnard, California | |
| Ospedale Casa Sollievo della Sofferenza IRCCS San Giovanni Rotondo, | |
| Ottawa Hospital Ottawa, Ontario | |
| PROACTIVE CR MEXICO SA de CV Irapuato, | |
| Penn State Health Milton S. Hershey Medical Center Hershey, Pennsylvania | |
| Piedmont Atlanta Hospital / Piedmont Transplant Institute Atlanta, Georgia | |
| Pinnacle Clinical Research, PLLC San Antonio, Texas | |
| PlanetMed SP. z. o. o Wroclaw, | |
| Pontificia Universidad Catolica de Chile Santiago, | |
| Prince of Wales Hospital - Hong Kong Hong Kong, | |
| Princess Alexandra Hospital Woolloongabba, | |
| Princess Margaret Hospital - Hong Kong Hong Kong, | |
| Pusan National University Hospital Busan, | |
| Queen Mary Hospital - PPDS Hong Kong, | |
| RESEARCH Site s.r.o Pilsen, | |
| Rize Recep Tayyip Erdogan University Training and Research Hospital Rize Merkez, | |
| Royal Free Hospital London, | |
| SCPMG/Kaiser Permanente Los Angeles Medical Center Los Angeles, California | |
| Samsung Medical Center Seoul, Gangnam-gu | |
| Schiff Center for Liver Diseases/University of Miami Miami, Florida | |
| Semmelweis Egyetem - Sebészeti, Budapest, | |
| Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do | |
| Seoul National University Hospital Seoul, Seoul Teugbyeolsi | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Shanghai Jiaotong University School of Medicine, Renji Hospital Shanghai, | |
| Sheffield Teaching Hospital NHS Foundation Trust Sheffield, | |
| Singapore General Hospital (SGH) Singapore, | |
| Soma Clinical Trials Denison, Texas | |
| Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvár, | |
| St. Joseph's Hospital and Medical Center - 350 W. Thomas Phoenix, Arizona | |
| Stanford University Palo Alto, California | |
| Tan Tock Seng Hospital Singapore, | |
| The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, | |
| The Cleveland Clinic Foundation Cleveland, Ohio | |
| The First Affiliated Hospital of Anhui Medical University Hefei, Anhui | |
| The First Affiliated Hospital of PLA Air Force Medical University Xi'an, | |
| The First Affiliated Hospital of Xi'An Jiaotong University Xi’an, Shanxi | |
| The First Affiliated Hospital of Xinjiang Medical University Ürümqi, | |
| The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The First People's Hospital of Yunnan Province Kunming, Yunnan | |
| The Liver Institute at Methodist Dallas Medical Center Dallas, Texas | |
| The Ohio State University Medical Center Columbus, Ohio | |
| The Royal London Hospital London, | |
| The Second Affiliated Hospital Of Chongqing Medical University Chongqing, Chongqing Municipality | |
| The Second Hospital of Nanjing Nanjing, | |
| The Third Affiliated Hospital, Sun Yat-sen University Guangzhou, | |
| The Third People's Hospital of Zhenjiang Zhenjiang, | |
| Thomas Jefferson University Philadelphia, Pennsylvania | |
| Toronto General Hospital Toronto, Ontario | |
| UZ Antwerpen Edegem, | |
| UZ Gent Ghent, Oost-Vlaanderen | |
| UZ Leuven - PPDS Leuven, | |
| Uludag University Medical Faculty Görükle, | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan, | |
| Universitatsspital Bern Bern, | |
| Universitatsspital Zurich Zurich, | |
| University General Hospital of Larissa Larissa, | |
| University Health System - East Jefferson General Hospital Campus New Orleans, Louisiana | |
| University Hosptials Cleveland Medical Center Cleveland, Ohio | |
| University of Alberta Edmonton, | |
| University of Calgary Calgary, Alberta | |
| University of California, Davis Medical Center Sacramento, California | |
| University of Chicago Medical Center Chicago, Illinois | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| University of Louisville, Clinical Trials Unit Louisville, Kentucky | |
| University of Pennsylvania Perelman Center for Advanced Medicine Philadelphia, Pennsylvania | |
| University of Rochester Medical Center - Strong Memorial Hospital Rochester, Minnesota | |
| University of Texas Southwestern Medical Center, Professional Office Building One Dallas, Texas | |
| Universitätsklinikum des Saarlandes Homburg, | |
| Upmc Center For Liver Diseases Pittsburgh, Pennsylvania | |
| VCU Health Clinical Research Services Unit (CRSU) Richmond, Virginia | |
| Wake Forest Baptist Medical Center Winston-Salem, North Carolina | |
| Walter Reed National Military Bethesda, Maryland | |
| West China Hospital of Sichuan University Sichuan, | |
| hospital Italiano de Buenos Aires Buenos Aires, | |
| the First Hospital of Jilin University Changchun, Jilin |
A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events (Talisman)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT06500884
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Multiple myeloma (MM) according to IMWG diagnostic criteria
* Were triple-class exposed (received prior treatment with a PI, an IMiD, and anti CD38 mAb)
* Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
* Have an Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0 or 1 at screening. Participants with ECOG-PS 2 or 3 are eligible for the study if the ECOG-PS score is related to stable physical limitations (e.g., wheelchair-bound due to prior spinal cord injury) and not related to multiple myeloma or associated therapy
* Be willing and able to adhere to the lifestyle restrictions specified in the protocol
Exclusion Criteria:
* Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients
* Stroke, transient ischemic attack, or seizure within 6 months prior to screening
* Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction; major thromboembolytic event (e.g., pulmonary embolism, cerebrovascular accident), clinically significant ventricular arrythmia or heart failure New York Heart Association functional classification Class III or IV. Uncomplicated deep vein thrombosis is not considered exclusionary
* Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
* A WETT score indicating severe dysgeusia at screening and confirmed prior to randomization. Also unresolved/severe dysgeusia referred by the participant or a finding in the physical examination/oral cavity inspection. Some examples include leukoplakia, prior mouth cancers, extensive dental caries, severe periodontitis, active oral infections, candidiasis, parotic gland removal, or radiotherapy with resultant xerostomia DRUG: Talquetamab, DRUG: Prophylaxis A, DRUG: Prophylaxis B, DRUG: Prophylaxis C, DRUG: Prophylaxis D, DRUG: Ramantamig
Multiple Myeloma
I'm interested
Share via email
Show 38 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Albert Schweitzer Ziekenhuis Dordrecht, | |
| Belfast City Hospital Belfast, Northern Ireland | |
| Clinica Medica Sao Germano S/S LTDA São Paulo, | |
| Colchester Hospital University NHS Colchester, | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Duke University Medical Center Durham, North Carolina | |
| Eastbourne District General Hospital Eastbourne, | |
| Erasmus MC Rotterdam, | |
| Fundação Universidade de Caxias do Sul Caxias do Sul, | |
| Hammersmith Hospital London, | |
| Hosp Clinic de Barcelona Barcelona, | |
| Hosp Clinico Univ de Salamanca Salamanca, | |
| Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcón, | |
| Hosp. Univ. 12 de Octubre Madrid, | |
| Hosp. Univ. Germans Trias I Pujol Badalona, | |
| Hosp. Univ. Ramon Y Cajal Madrid, | |
| Hosp. Univ. Virgen de La Arrixaca El Palmar, | |
| Hosp. de Jerez de La Frontera Jerez de la Frontera, | |
| Hospitais Integrados da Gavea SA DF Star Brasília, | |
| Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer Curitiba, | |
| Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center San Juan, | |
| Icahn School of Medicine at Mt. Sinai New York, New York | |
| Instituto D Or de Pesquisa e Ensino Brasília, | |
| Instituto D Or de Pesquisa e Ensino IDOR São Paulo, | |
| Newcastle Freeman Hospital Newcastle upon Tyne, | |
| Samsung Medical Center Seoul, Gangnam-gu | |
| Seoul National University Hospital Seoul, Seoul Teugbyeolsi | |
| The Catholic University of Korea Seoul St Mary s Hospital Seoul, | |
| The Christie NHS Foundation Trust Christie Hospital Manchester, | |
| The Clatterbridge Cancer Centre Liverpool, | |
| University College London Hospitals London, | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of California San Francisco San Francisco, California | |
| University of Rochester Medical Center Rochester, New York | |
| University of Washington Seattle, Washington | |
| VUmc Amsterdam Amsterdam, | |
| Virginia Commonwealth University - Massey Cancer Center Richmond, Virginia | |
| Yale University School of Medicine North Haven, Connecticut |
Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (LCN RESCU)
Crystal Santillanes, MS - lcn@northwestern.edu
NCT05832229
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Age 18-75 years
• Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus)
• Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:
• At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR
• At least 2 of the following: i. Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past 48 weeks ii. Liver stiffness: vibration-controlled transient elastography within 48 weeks prior to consent or during Screening ≥15 kilopascal or magnetic resonance elastography within 48 weeks prior to consent or during Screening ≥5 kilopascal iii. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening iv. Either: Fibrosis-4\>2.67 or platelets \<150/mL within 6 months prior to consent or during Screening
• Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria:
• The first measure must be ≥ 15 kilopascal.
• The two measures must be at least 2 hours apart and no more than 60 days apart from one another.
• The mean of two measurements must be ≥ 15 kilopascal.
• Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa
• Compensated defined by:
• Absence of ascites/hydrothorax, hepatic encephalopathy or variceal bleeding currently or in the last 48 weeks, as determined clinically by investigator.
• If prior history of decompensation, must be without current symptoms of decompensation and no longer requiring treatment of complications for the last 48 weeks, including the use of diuretics for the treatment of ascites, and/or rifaximin or lactulose for the treatment of hepatic encephalopathy. Use of non-selective beta blockers will be allowed.
• Child-Pugh score \<8
• Provision of written informed consent.
Exclusion Criteria:
• Currently on a statin or any statin exposure within 24 weeks prior to consent.
• Known indication for statin therapy, defined as:
• Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR
• Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR
• Fasting LDL-C ≥ 190 mg/dL
• Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening.
• Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening.
• Patients with limitations in attending study visits.
• Prisoners.
• Known prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma.
• Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence.
• Current (in past 24 weeks prior to consenting) use of medications known to cause hepatic fibrogenesis or confound endpoint assessment, defined as:
• amiodarone
• methotrexate
• warfarin
• Current (in past 24 weeks prior to consenting) use of medications which may increase risk for rosuvastatin-related myositis or DILI, defined as:
• fenofibrate
• erythromycin
• gemfibrozil
• niacin (500 mg or more)
• HIV protease inhibitors (darunivar, indinavir, nelfinavir, amprenavir) in patients of East Asian descent
• colchicine
• cyclosporin
• Additional medications that will be excluded: atazanavir/ritonavir capmatinib darolutamide dasabuvir/ombitasvir/paritaprevir/ritonavir ledipasvir/sofosbuvir elbasvir/grazoprevir erythromycin glecaprevir/pibrentasvir lopinavir/ritonavir regorafenib ritonavir, in any combination simeprevir sofbuvir/velpatasvir/voxilaprevir sofosbuvir/velpatasvir tafamidis teriflunomide \*If exposure was for 7 or less days for one of these medications can consider enrollment after 28 days from final dose.
• Presence of portal or hepatic vein thrombosis
• Diagnosis of untreated hypothyroidism or on unstable treatment regimen for hypothyroidism
• Receiving an elemental diet or parenteral nutrition
• Chronic pancreatitis or pancreatic insufficiency
• Etiology of cirrhosis other than ALD, NAFLD, or viral hepatitis (excluded diagnoses include cryptogenic immune-mediated such as AIH, PSC and PBC, cardiac cirrhosis or Fontan-associated liver disease, A1AT, Wilson's disease, etc.)
• Conditions which may confound study outcome:
• Unstable or active inflammatory bowel disease
• Active infection
• Any malignant disease (other than squamous or basal cell carcinoma of the skin) within previous 3 years
• Prior solid organ or hematopoietic cell transplant
• Bariatric surgery in the last 24 weeks prior to consent or planned bariatric surgery within the next 96 weeks
• Current liver-unrelated end-stage organ failures such as end-stage renal disease on dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen.
• Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study for safety reasons or interfere with or prevent adherence to the protocol.
• The following laboratory abnormalities within 90 days of screening:
• Hemoglobin \<10 g/dL
• Albumin \<3.0 g/dL
• Prolonged international normalized ratio (INR) \>1.5
• Total bilirubin ≥ 2.0 mg/dl (unless due to Gilbert's syndrome or hemolysis as denoted by normal direct bilirubin fraction)
• Direct bilirubin ≥ 0.9
• Uncontrolled diabetes (HbA1c ≥ 9.5%) within past 90 days.
• Kidney function abnormalities including:
• Dialysis
• Baseline eGFR \< 30 cc/min with CKD-Epi equation
• Known nephrotic proteinuria, defined as 3g or greater of protein in 24-hour urine collection
• Recent (within 48 weeks) or present hepatic decompensation with ascites/hydrothorax, hepatic encephalopathy or variceal bleeding
• Untreated chronic hepatitis B or C infection
• HCV eligible for enrollment if HCV RNA negative at baseline or documentation of prior SVR12
• HBV eligible if an HBV DNA \<100 IU/mL within the last 48 weeks and on treatment
• Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 200 U/L, or alkaline phosphatase (ALP) ≥ 300 within the past 24 weeks.
• Documented history of intolerance to statins
• Serious comorbid medical disease which in the investigator's opinion renders a life-expectancy less than 96 weeks
• Active illicit substance use (other than THC), including inhaled or injected drugs, in the 24 weeks prior to screening
• Pregnancy, planned pregnancy or breastfeeding
• Current participation in active medication treatment trials (within 24 weeks prior to randomization) or planned participation in active medication treatment trials simultaneous to participation in present trial.
• Significant existing muscle pain or tenderness or prior history of myasthenia gravis as determined by a site physician.
• Failure or inability to provide informed consent.
DRUG: Rosuvastatin
Cirrhosis, Cirrhosis, Liver, Cirrhosis Early, Cirrhosis Due to Hepatitis B, Cirrhosis Advanced, Cirrhosis Infectious, Cirrhosis Alcoholic, Cirrhosis Due to Hepatitis C
Cirrhosis, Liver, Nonalcoholic Fatty Liver Disease
I'm interested
Share via email
Show 13 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Cleveland Clinic Cleveland, Ohio | Srinivasan Dasarathy - (DASARAS@ccf.org) |
| Columbia University Iriving School of Medicine New York, New York | Elizabeth Verna - (ev77@cumc.columbia.edu) |
| Duke Liver Center Durham, North Carolina | Cynthia Ann Moylan, MD, MHS, MS - (cynthia.moylan@duke.edu) Mariko Kopping - (mariko.kopping@duke.edu) |
| Keck Medical Center of USC Los Angeles, California | Norah Terrault - (norah.terrault@med.usc.edu) |
| LAC + USC Medical Center Los Angeles, California | Norah Terrault - (norah.terrault@med.usc.edu) |
| Mayo Clinic Rochester, Minnesota | Doug A. Simonetto, MD - (simonetto.douglas@mayo.edu) |
| New York Presbyterian/Weill Cornell New York, New York | Robert Brown - (rsb2005@med.cornell.edu) |
| UCSF Medical Center San Francisco, California | Bilal Hameed - (bilal.hameed@ucsf.edu) |
| UCSF/Zuckerberg San Francisco General Hospital and Trauma Center San Francisco, California | Mandana Khalili - (Mandana.Khalili@ucsf.edu) |
| University of California San Diego NAFLD Research Center La Jolla, California | Rohit Loomba - (roloomba@health.ucsd.edu) |
| University of Miami Health System Miami, Florida | David Goldberg - (dsgoldberg@med.miami.edu) |
| University of Michigan Ann Arbor, Michigan | Elliot Tapper - (etapper@med.umich.edu) |
| Virginia Commonwealth University Richmond, Virginia | Arun Sanyal - (arun.sanyal@vcuhealth.org) |
FearLess in NeuroOncology
Mary Bridgman - LiveNOW@vcu.edu
NCT06989086
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Patients:
* Self-report a diagnosis of a primary malignant brain tumor (grade II-IV)
* \>2 weeks post-cranial resection or biopsy
* Elevated Fear of Recurrence Distress Rating
* Primarily English speaking
* \>/= 18 years of age at the time of enrollment
Caregivers:
* nonprofessional caregiver to a patient with a primary malignant brain tumor (grade II-IV)
* Elevated Fear of Recurrence Distress Rating
* Primarily English speaking
* \>/= 18 years of age at the time of enrollment
Exclusion Criteria:
Patient / Caregiver Exclusion:
* Cognitive impairment that might prohibit active intervention engagement
* Inability to understand and provide informed consent
* Inability to attend virtual sessions due to unstable or no internet connection BEHAVIORAL: Fearless in Neuro-Oncology
Primary Malignant Brain Tumor, Glioblastoma (GBM), Astrocytoma, Oligodendroglioma, Caregiver
brain tumor
I'm interested
Share via email
Show 1 location
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Ashlee Loughan, PhD - (ashlee.loughan@vcuhealth.org) |
A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease
ctrrecruit@vcu.edu
NCT06765668
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Participants with PD consistent with the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria and who are being treated with stable regimens of oral CD-LD.
• Participants with a score of at least 20 units at Screening on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score in the "Off" state.
• Participants with predictable "Off" periods at Screening defined by a score of 1 or 2 (Complexity of Motor Fluctuations) of the MDS-UPDRS Part IV B (Motor Fluctuations).
• By history, for the 4 weeks (28 days) prior to Screening, the participant experiences.
• Daily predictable "wearing-off" episodes with periods of worsening motor symptoms.
• An average of at least 2.5 cumulative hours per day of "Off" time, during the hours the participant awake.
• At Screening, the participant is able to differentiate "On" state from "Off" state as determined by at least 75 percentage (%) concordance with a trained rater (that is, investigator or qualified and certified site staff) in "On/Off" ratings for 8 ratings over a 4-hour training period. The concordance must include at least one "On" and one "Off" rating in this 4-hour training period.
• If the concordance is less than 75%, or if it does not include at least one "On" and one "Off" rating within the first 4-hour training period, a second 4-hour training period should be conducted with the participant before being considered for inclusion in the study.
• If during the second 4-hour training-period a concordance of at least 75% is also not achieved, or if it does not include at least one "On" and one "Off" rating, the participant cannot be included in the study.
• At baseline (Visit 1), review of the 3-day PD diaries confirms the following:
• The participant is able to properly complete the PD diaries with valid entries. Inability to properly complete the diaries is indicated when more than 1 day of a diary is not returned or if more than 1 day of the diary is not valid (that is, more than 2 hours \[4 half-hour periods\] of the 24-hour diary day are missing); and
• The participant has an average of at least 2.5 hours per day of "Off" time, during the hours the participant is awake, over the 3 PD diary days; and
• The participant has at least 1.5 hours of cumulative "Off" time, during the hours the participant is awake, on each of the 3 PD diary days.
• Participant is responsive to CD-LD therapy and currently being treated on a stable regimen of oral CD-LD for at least 4 weeks (greater than equal to \[\>=\] 28 days) prior to baseline (Visit 1) and meets the following criteria: a. Daily Dose Requirements: i. All participants should be taking at least 100 mg of immediate-release (IR) CD-LD or 195 mg of Rytary for the first morning dose. ii. For participants taking IR CD-LD (with or without a bedtime dose of CR CD-LD): * Require a total daily dose of at least 300 mg of LD and a maximum total daily dose of less than equal to \[\<=\]1200 mg LD (from IR CD-LD alone or from IR CD-LD in combination with a single daily bedtime dose of CR CD-LD). * The maximum individual dose allowed is 250 mg of LD. * The minimum individual dose should be at least 100 mg of LD. iii. For participants using a catechol-O-methyltransferase (COMT) inhibitor: * Require a total daily dose of at least 300 mg of LD and a maximum total daily dose of less than \[\<\]1000 mg LD. * The maximum individual dose is 200 mg of LD. iv. For participants using Rytary: * Require a total daily dose of at least 585 mg of LD and a maximum total daily dose of \<2100 mg LD. * The maximum individual dose is 685 mg of LD. b. Dose Frequency Requirement: i. If a participant is using IR/CR CD-LD alone or in combination with a COMT inhibitor, then the dosing frequency must be 3 to 6 times daily. ii. If a participant is using Rytary, then the dosing frequency must be 3 to 4 times daily.
• Participant is able and willing to provide written informed consent prior to the conduct of any study-specific procedures.
• Participant is able and willing to comply with the protocol, including completion of PD diaries, questionnaires, and available for all study visits and telephone calls.
• Participants who have participated in prior CREXONT clinical studies are allowed to be enrolled in this Phase 4 study.
Exclusion Criteria:
• Participant who, in the opinion of the clinical investigator, should not participate in the study based on the CREXONT Prescribing Information.
• Participant had a prior neurosurgical treatment for PD (example, deep brain stimulation \[DBS\] surgery or neurosurgical ablation treatment procedures) or if such procedure is planned or anticipated prior to Visit 4 (Day 42) of the study.
• Participant received the following within 4 weeks (\<=28 days) prior to baseline (Visit 1)
• Any doses of a CR CD-LD apart from a single daily bedtime dose.
• Duopa.
• Nonselective monoamine oxidase inhibitor (MAOI).
• Rescue medication used to treat "off" episodes for example: apomorphine or inhaled LD (Inbrija®).
• Received any investigational drugs within 30 days or 5 times the half-life, whichever is longer, prior to baseline (Visit 1).
• Participant who, in the opinion of the clinical investigator, should not participate in the study (example, based on clinical assessment, participant does not adequately comprehend the terminology needed to complete the PD diary and participant -reported outcomes, or any other reason).
• Employees or family members of the investigator, or study site staff, or Sponsor.
DRUG: CREXONT ER
Parkinson Disease
I'm interested
Share via email
Show 27 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Atrium Health Wake Forest Baptist Adult Neurology - Janeway Tower Winston-Salem, North Carolina | Deepal Shah-Zamora - (dshahzam@wakehealth.edu) |
| Barrow Neurological Institute Phoenix, Arizona | Nicki Niemann - (MovementResearch@dignityhealth.org) |
| Central DuPage Hospital - Movement Disorders Center Winfield, Illinois | Martha McGraw - (Martha.McGraw@nm.org) |
| Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas, Nevada | Zoltan Mari - (Mariz@ccf.orh) |
| Icahn School of Medicine at Mount Sinai New York, New York | Joohi Shahed - (joohi.jimenez-shahed@mountsinai.org) |
| Inova Neurology Fairfax, Virginia | Drew Falconer - (drew.falconer@inova.org) |
| MedStar Georgetown University Hospital Department of Neurology McLean, Virginia | Fernando Pagan - (LL928@georgetown.edu) |
| N1 Research LLC Orlando, Florida | Ramon Rodriguez - (rodriguez@neurologyone.com) |
| NeuroScience Research Center, LLC Canton, Ohio | Ryan Drake - (rsddo@neurocarecenter.com) |
| Neurology Consultants of Dallas, PA Dallas, Texas | Nirav Pavasia - (npavasia@neurologydallas.com) |
| Parkinson's Research Centers of America - Long Island Commack, New York | David Kreitzman - (info_LongIsland@parkinsonscenter.org) |
| Parkinson's Research Centers of America - Orange County Aliso Viejo, California | Mindy Bixby - (Bixby_research@parkinsonscenter.org) |
| Parkinson's Research Centers of America - Palo Alto Palo Alto, California | Salima Brillman - (info_PaloAlto@parkinsonscenter.org) |
| Parkinsons Disease and Movement Disorders Center of Boca Raton Boca Raton, Florida | Stuart Isaacson - (info@parkinsonscenter.org) |
| QUEST Research Institute Farmington Hills, Michigan | Aaron Ellenbogen - (aaron@questri.com) |
| Texas Movement Disorder Specialists, PLLC Georgetown, Texas | Michael Soileau - (msoileau@txmds.net) |
| The Movement Disorder Clinic of Oklahoma Tulsa, Oklahoma | Kevin Klos - (kevin.klos@mdcok.com) |
| The University of Texas Health Science Center at Houston- McGovern Medical School Houston, Texas | Mya Schiess - (Mya.C.Schiess@uth.tmc.edu) |
| USF Parkinson's Disease and Movement Disorders Center Tampa, Florida | Robert Hauser - (rhauser@usf.edu) |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | Camilla Kilbane - (Camilla.Kilbane@uhhospitals.org) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | Rohit Dhall - (rdhall@uams.edu) |
| University of Cincinnati Cincinnati, Ohio | Alberto Espay - (espayaj@ucmail.uc.edu) |
| University of Kansas Medical Center Kansas City, Kansas | Angela Richmond - (arichmond4@kumc.edu) |
| University of Miami Miami, Florida | Jason Margolesky - (jhmargolesky@med.miami.edu) |
| Univesity of Miami - Miller School of Medicine Boca Raton, Florida | Henry Moore - (HMoore@med.miami.edu) |
| VCU Parkinsons Disease and Movement Disorders Center Henrico, Virginia | Leslie Cloud - (Leslie.Cloud@vcuhealth.org) |
| Visionary Investigators Network Aventura, Florida | Julie Schwartzbard - (DrJ@aventuraneuro.com) |
A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis (Kirros)
Reference Study ID Number: ML44719 https://forpatients.roche.com/ - global-roche-genentech-trials@gene.com
NCT06096779
Show full eligibility criteria
Hide eligibility criteria
General
Inclusion Criteria:
* Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants
* Disease that is not amenable to curative surgical and/or locoregional therapies
* No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC
* Measurable disease (at least one untreated target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days prior to initiation of study treatment
* Child-pugh B7 or B8 cirrhosis at screening and within 7 days prior to study treatment
* Adequate hematologic and end-organ function
* Life expectancy of at least 12 weeks
* Female participants of childbearing potential must be willing to avoid pregnancy and egg donation
* Absolute neutrophil count ≥1.0 x 10\^9 per liter (/L) (≥1000 per microliter \[/μL\]) without granulocyte colony-stimulating factor support
* Platelet count ≥ 50 × 109/L (50,000/μL) without transfusion
* Hemoglobin ≥ 80 grams per liter (g/L) (8 grams per deciliter \[g/dL\]) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × upper limit of normal (ULN)
* Serum bilirubin ≤ 3 × ULN
* Creatinine clearance ≥ 50 milliliters per minute (mL/min) (calculated using the Cockcroft-gault formula)
* Serum albumin ≥ 20 g/L (2.0 g/dL) without transfusion in the prior 3 months
* International normalized ratio (INR) ≤2.3
General Exclusion Criteria:
* Pregnancy or breastfeeding
* Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies
* Treatment with investigational therapy within 28 days prior to initiation of study treatment
* Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure
* Treatment with systemic immunostimulatory agents
* Treatment with systemic immunosuppressive medication
* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
* Inadequately controlled hypertension
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Participants who have a known concurrent malignancy that is progressing or requires active treatment, who have not completely recovered from treatment, or who have a significant malignancy history that, in the opinion of the investigator, should preclude participation
* Participants on preventative hormonal therapies (i.e., tamoxifen and other hormonal inhibitors) are not excluded
* Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Prior allogeneic stem cell or solid organ transplantation
* Actively listed for liver transplantation
* Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
* Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
* A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
* Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of study treatment
* Hepatic encephalopathy is allowed if no active symptoms or stable within 3 months of study treatment
* History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS) is excluded from Cohort A only. TIPS is acceptable in Cohort B
* Diagnostic paracentesis is allowed. Therapeutic paracentesis: one large volume paracentesis prior to enrollment with diuretic controlled ascites is allowed.
* Participants with ascites controlled on diuretics are allowed
* History of spontaneous bacterial peritonitis within last 12 months DRUG: Atezolizumab, DRUG: Bevacizumab
Hepatocellular Carcinoma
Cirrhosis, Liver Cancer, Liver Tumor, Child-pugh B, Hepatocellular Carcinoma, Atezolizumab, Bevacizumab, Immune Checkpoint Inhibitor, Digestive System Neoplasms, Kirros, ML44719, Liver Disease, Genentech, Immunotherapy, CPB, CPB 7, CPB 8, Tecentriq, Avastin, HCC, Cirrhotic Liver, Fatty Liver
I'm interested
Share via email
Show 61 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Barbara Ann Karmanos Cancer Institute Detroit, Michigan | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Bon Secours St. Mary's Hospital Richmond, Virginia | |
| California Liver Research Institute Pasadena, California | |
| Cedars Sinai Comprehensive Transplant Center West Hollywood, California | |
| Dayton VA Medical Center - NAVREF - PPDS Dayton, Ohio | |
| Harbor UCLA Medical Center Torrance, California | |
| Hartford Healthcare Cancer Institute at Hartford Hospital Hartford, Connecticut | |
| Henry Ford Health System Detroit, Michigan | |
| Houston Methodist Hospital Houston, Texas | |
| Icahn School of Medicine at Mount Sinai New York, New York | |
| Inova Schar Cancer Institute Fairfax, Virginia | |
| Intermountain Cancer Center St. George, Utah | |
| Intermountain Healthcare Salt Lake City, Utah | |
| James J Peters Veterans Administration Medical Center - NAVREF The Bronx, New York | |
| Jefferson Health Honickman Center Philadelphia, Pennsylvania | |
| Kaiser Permanente Westside Medical Center Hillsboro, Oregon | |
| Kelsey Research Foundation Houston, Texas | |
| LSU Health Baton Rouge Baton Rouge, Louisiana | |
| Levine Cancer Institute Charlotte, North Carolina | |
| Liver Institute at Methodist Dallas Dallas, Texas | |
| Long Island Heart Associates Mineola, New York | |
| Maryview Hospital, Inc. Newport News, Virginia | |
| Michael E Debakey VA Medical Center - NAVREF - PPDS Houston, Texas | |
| Montefiore Medical Center The Bronx, New York | |
| Moody Outpatient Center ? Parkland Health Dallas, Texas | |
| MorristownMedicalCenter Morristown, New Jersey | |
| NYU Langone Medical Center New York, New York | |
| Nashville General Hospital at Meharry Nashville, Tennessee | |
| Northwestern University Chicago, Illinois | |
| OHSU Knight Cancer Institute Hematology Oncology Portland, Oregon | |
| Orlando Health Inc. Orlando, Florida | |
| Our Lady of the Lake Cancer Institute Baton Rouge, Louisiana | |
| Pan American Center for Oncology Trials, LLC Rio Piedras, | |
| R.J. Zuckerberg Cancer Hospital/Northwell Health - BRANY - PPDS New Hyde Park, New York | |
| Rocky Mountain Cancer Centers (Williams) - USOR Denver, Colorado | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Rutgers Cancer Institute of New Jersey at University Hospital Newark, New Jersey | |
| Saint Luke?s Hospital of Kansas City Kansas City, Missouri | |
| Stanford Health Care San Jose, California | |
| Texas Oncology (Worth) - USOR Dallas, Texas | |
| Texas Oncology - Denison Cancer Center Denison, Texas | |
| The Duchossois Center for Advanced Medicine Chicago, Illinois | |
| The University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| The West Clinic (East Campus) Germantown, Tennessee | |
| Tufts Medical Center Boston, Massachusetts | |
| UC San Diego Moores Cancer Center La Jolla, California | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of Arizona Cancer Center Tucson, Arizona | |
| University of California Davis Medical Center Sacramento, California | |
| University of California Irvine Medical Center Orange, California | |
| University of Illinois Health Outpatient Care Center Chicago, Illinois | |
| University of Kentucky - Markey Cancer Center Lexington, Kentucky | |
| University of Southern California Los Angeles, California | |
| University of Southern California-Keck School of Medicine -1975 Zonal Ave Los Angeles, California | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| VCU Medical Center North Hospital Richmond, Virginia | |
| Veterans Affairs Ann Arbor Healthcare System Ann Arbor, Michigan | |
| Veterans Affairs Pittsburgh Healthcare System - NAVREF - PPDS Pittsburgh, Pennsylvania | |
| Virginia Mason Medical Center Seattle, Washington | |
| Washington DC VA Medical Center Washington D.C., District of Columbia |
Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein
Takeda Contact - medinfoUS@takeda.com
NCT05677971
Show full eligibility criteria
Hide eligibility criteria
Inclusion criteria:
* The participant must have a diagnosis of the Z allele homozygotes (PiZZ) genotype AATD. PiZZ diagnosis from source verifiable medical records is permitted. Otherwise, participants must undergo PiZZ confirmatory testing (genotyping for PiS and PiZ alleles) at screening. PiMZ or PiSZ genotypes are not permitted.
* The participant, of any sex, is aged 18 to 75 years, inclusive.
* The participant's liver biopsy core sample collected should meet the requirements of the protocol.
* The participant has evidence of METAVIR stage F2, F3, or F4 liver fibrosis, evaluated by a centrally read baseline liver biopsy during the screening period; or confirmed as meeting all the entry criteria by central reading of a previous biopsy conducted within 6 months before the estimated enrollment date using an adequate liver biopsy and slides as defined in the study laboratory manual.
* The participant has a pulmonary status meeting the protocol's requirements.
* It must be confirmed that the participant does not have HCC. Participants will be screened for HCC with alpha-fetoprotein (AFP) and abdominal ultrasound. If the participant has any of the following, they will be required to have contrast-enhanced CT or MRI imaging to exclude HCC before randomization.
* An adult participant must have a body mass index (BMI) between 18.0 and 39.0 kilograms per meter square (kg\^m2), inclusive.
* The participant is a nonsmoker for at least 6 months before screening.
Exclusion Criteria
* The participant has a history of liver decompensating events (overt hepatic encephalopathy \[West Haven Grade \>=2\] documented by a physician, clinically significant ascites, spontaneous bacterial peritonitis, GI bleeding from varices, hepatopulmonary syndrome, hepatorenal syndrome, portal pulmonary hypertension, or bleeding portal hypertensive gastropathy).
* The participant has a history of the presence of medium or large varices or varices with red wale signs based on a previous esophagogastroduodenoscopy (EGD) within 6 months before the estimated enrollment date. For certain participants, an EGD will be required at screening if there is no EGD available within 6 months before the estimated enrollment date. Presence of small varices with no red wale signs on EGD and no history of bleeding will be acceptable for study eligibility.
* The participant has evidence of other forms of chronic liver diseases, including viral hepatitis B or C, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, alcoholic hepatitis, hemochromatosis, liver cancer, history of biliary diversion, or autoimmune hepatitis.
* The participant has alanine transaminase (ALT) or aspartate transaminase (AST) levels \>250 units per liter (U/L).
* The participant has a platelet count \<60,000 per cubic millimeter (mm\^3) (\<60 × 10\^9 per liter \[10\^9/L\]).
* The participant has albumin \<=2.8 gram per deciliter (g/dL) (28 grams per deciliter \[g/L\]).
* The participant has international normalized ratio (INR) \>=1.7.
* The participant is expected to have severe and unavoidable high-level exposure to inhaled pulmonary toxins during the study such as may occur with occupational exposure to mineral dusts or metals.
* The participant has a history of drug abuse (such as cocaine, phencyclidine) within 1 year before the screening visit or has a positive urine drug screen at screening.
* The participant has previously been treated with fazirsiran or any other RNAi for AATD-LD.
* The participant has portal vein thrombosis.
* The participant has a prior transjugular portosystemic shunt procedure.
* The participant has a history of malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer. Participants with other curatively treated malignancies who have no evidence of metastatic disease and a greater than 1-year disease-free interval may be entered after approval by the medical monitor.
DRUG: Fazirsiran Injection, OTHER: Placebo
Alpha1-Antitrypsin Deficiency
I'm interested
Share via email
Show 89 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Addenbrooke's Hospital Cambridge, | Site Contact - (Bill.griffiths@nhs.net) |
| Amsterdam UMC - VUmc - De Boelelaan Amsterdam, | |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, | Site Contact - (vincenza.calvaruso@unipa.it) |
| Baylor College of Medicine Medical Center Houston, Texas | Site Contact - (george.cholankeril@bcm.edu) |
| Beaumont Hospital Dublin, Co Dublin | Site Contact - (gmcelvaney@rcsi.ie) |
| Bon Secours St. Mary's Hospital Richmond, Virginia | Site Contact - (mitchell_shiffman@bshsi.org) |
| Boston Medical Center Boston, Massachusetts | Site Contact - (amohanty@bu.edu) |
| Brigham and Womens Hospital Boston, Massachusetts | Site Contact - (NHASHEMI@BWH.HARVARD.EDU) |
| CCA Hospital Braga Braga, | Site Contact - (crolanda@med.uminho.pt) |
| Cardinal Glennon Children's Hospital St Louis, Missouri | Site Contact - (jeffrey.teckman@slucare.ssmhealth.com) |
| Centre Francois Magendie Pessac, | Site Contact - (maeva.zysman@chu-bordeaux.fr) |
| Centro Hospitalar do Porto Porto, | Site Contact - (luisazevedomaia@hotmail.com) |
| Charité - Campus Virchow-Klinikum-Ostring 1 Berlin, | Site Contact - (frank.tacke@charite.de) |
| Children's Healthcare of Atlanta Atlanta, Georgia | |
| Columbia University Irving Medical Center New York, New York | Site Contact - (mpg2124@cumc.columbia.edu) |
| Derriford Hospital Plymouth, | Site Contact - (ashwin.dhanda@nhs.net) |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, | Site Contact - (luca.valenti@policlinico.mi.it) |
| Fondazione IRCCS Policlinico San Matteo di Pavia Pavia, | Site Contact - (corsico@unipv.it) |
| GI Research Institute Vancouver, British Columbia | Site Contact - (hinnih@gmail.com) |
| Gastroenterology & Liver Institute Escondido, California | |
| Hannover Medical School Hanover, | Site Contact - (wedemeyer.heiner@mh-hannover.de) |
| Henry Ford Medical Center - Columbus Detroit, Michigan | Site Contact - (sgordon3@hfhs.org) |
| Hopital Beaujon Clichy, | Site Contact - (kathleenlourdes.milord@aphp.fr) |
| Hopital PONTCHAILLOU CHU de Rennes Rennes, | Site Contact - (edouard.bardou-jacquet@chu-rennes.fr) |
| Hopital Paul Brousse Val-de-Marne, | Site Contact - (audrey.coilly@aphp.fr) |
| Hopital de la Croix Rousse Lyon, Auvergne-Rhône-Alpes | Site Contact - (teresa.antonini@chu-lyon.fr) |
| Hospital Nélio Mendonça Funchal, | Site Contact - (magnovitorp@gmail.com) |
| Hospital Purpan Toulouse, | Site Contact - (alric.l@chu-toulouse.fr) |
| Hospital Sírio-Libanês São Paulo, São Paulo | Site Contact - (gildaporta@gmail.com) |
| Hospital Universitario Marqués de Valdecilla Santander, | Site Contact - (alvaro.diaz@scsalud.es) |
| Hospital Universitario Vall d'Hebron - PPDS Barcelona, | Site Contact - (monica.pons@vhir.org) |
| Hospital Universitario Virgen de la Victoria Málaga, | Site Contact - (andrade@uma.es) |
| Hospital Universitario Virgen del Rocio - PPDS Seville, | Site Contact - (mromerogomez@us.es) |
| Hospital de Base do Distrito Federal Brasília, | Site Contact - (mendesliliana2@gmail.com) |
| Hvidovre Hospital Hvidovre, | Site Contact - (elias.badal.rashu@regionh.dk) |
| ID Clinic Arkadiusz Pisula Myslowice, Lesser Poland Voivodeship | |
| IRCCS Istituto Clinico Humanitas Rozzano, | Site Contact - (alessio.aghemo@humanitasresearch.it) |
| Indiana University School of Medicine - Indianapolis Indianapolis, Indiana | Site Contact - (rvuppala@iu.edu; mandcruz@iu.edu) |
| Inselspital Bern Bern, | Site Contact - (studien.hepatologie@insel.ch) |
| Inspiration Research Limited Toronto, Ontario | Site Contact - (kchapman@inspirationresearch.ca) |
| Institut klinicke a experimentalni mediciny Prague, | Site Contact - (jan.sperl@ikem.cz) |
| Karolinska Universitetssjukhuset Huddinge Huddinge, | Site Contact - (staffan.wahlin@ki.se) |
| King's College Hospital London, | Site Contact - (aftab.ala1@nhs.net) |
| Klinikum Klagenfurt am Wörthersee Klagenfurt, | Site Contact - (markus@peck.at) |
| LKH-Universitätsklinikum Graz Graz, | Site Contact - (martin.wagner@medunigraz.at) |
| Leiden University Medical Center Leiden, | Site Contact - (e.f.a.van_t_wout@lumc.nl) |
| Mayo Clinic Rochester, Minnesota | Site Contact - (vargas.hugo@mayo.edu) |
| Mayo Clinic - PPDS Rochester, Minnesota | Site Contact - (malhi.harmeet@mayo.edu) |
| Medical University of South Carolina Charleston, South Carolina | Site Contact - (strangec@musc.edu) |
| Medizinische Universitat Innsbruck Innsbruck, | Site Contact - (heinz.zoller@i-med.ac.at; hepa-studyteam@i-med.ac.at) |
| Medizinische Universität Wien (Medical University of Vienna) Vienna, | Site Contact - (mattias.mandorfer@meduniwien.ac.at) |
| Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY) - PIN New York, New York | |
| NYU Langone Health New York, New York | Site Contact - (viviana.figueroadiaz@nyulangone.org) |
| Ochsner Medical Center New Orleans, Louisiana | Site Contact - (gtherapondos@ochsner.org) |
| Peak Gastroenterology Associates, PC Colorado Springs, Colorado | Site Contact - (bpatel@peakgastro.com) |
| Penn State Health Milton S. Hershey Medical Center Hershey, Pennsylvania | Site Contact - (tcraig@pennstatehealth.psu.edu) |
| Queen Elizabeth II Health Sciences Center Halifax, Nova Scotia | Site Contact - (julie.zhu@nshealth.ca) |
| Queen's Medical Centre Nottingham, | |
| Royal Adelaide Hospital Adelaide, South Australia | |
| Royal Free Hospital London, | Site Contact - (aileen.marshall@nhs.net) |
| Royal Infirmary of Edinburgh Edinburgh, | Site Contact - (michael.williams@nhslothian.scot.nhs.uk) |
| Schiff Center for Liver Diseases/University of Miami Miami, Florida | Site Contact - (eschiff@med.miami.edu) |
| St Vincents Hospital Melbourne - PPDS Fitzroy, Victoria | Site Contact - (matthew.conron@svha.org.au) |
| St. Joseph's Hospital and Medical Center Phoenix, Arizona | Site Contact - (nilofar.najafian@commonspirit.org) |
| Stanford University Palo Alto, California | Site Contact - (pkwo@stanford.edu) |
| Temple University Hospital Philadelphia, Pennsylvania | Site Contact - (yedidya.saiman@tuhs.temple.edu) |
| Texoma Liver Center Denison, Texas | Site Contact - (h.elgouhari@somacinicaltrials.com) |
| The Texas Liver Institute San Antonio, Texas | Site Contact - (lawitz@txliver.com) |
| UCLA Pulmonary and Critical Care Los Angeles, California | Site Contact - (ibarjaktarevic@mednet.ucla.edu) |
| UZ Antwerpen Edegem, | Site Contact - (sven.francque@uza.be) |
| UZ Leuven Leuven, | Site Contact - (jef.verbeek@uzleuven.be) |
| Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu São Paulo, | Site Contact - (fgromeiro@gmail.com) |
| Universitetssjukhuset i Linköping Linköping, | Site Contact - (mattias.ekstedt@liu.se) |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | Site Contact - (seth.sclair@uhhospitals.org) |
| University of Alabama at Birmingham Birmingham, Alabama | Site Contact - (grayme@uab.edu) |
| University of Arizona Thomas D. Boyer Liver Institute Tucson, Arizona | |
| University of California Benioff Children's Hospital San Francisco, California | Site Contact - (PROSENTH@ucsf.edu) |
| University of California San Diego, Altman Clinical and Translational Institute La Jolla, California | Site Contact - (roloomba@health.ucsd.edu) |
| University of Florida Gainesville, Florida | Site Contact - (briana.foerman@medicine.ufl.edu) |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | Site Contact - (tomohiro-tanaka@uiowa.edu) |
| University of Maryland Medical Center Baltimore, Maryland | Site Contact - (kshetty@som.umaryland.edu) |
| University of Michigan Hospital Ann Arbor, Michigan | Site Contact - (rfontana@med.umich.edu) |
| Universitätsklinikum Schleswig-Holstein - Campus Kiel Kiel, | Site Contact - (rainer.guenther@uksh.de) |
| Universitätsklinikum Tübingen Tübingen, | Site Contact - (christoph.berg@med.uni-tuebingen.de) |
| Universitätsklinikum der RWTH Aachen Aachen, | Site Contact - (pstrnad@ukaachen.de) |
| VCU Medical Center North Hospital Richmond, Virginia | Site Contact - (amon.asgharpour@vcuhealth.org) |
| Vanderbilt University Medical Center Nashville, Tennessee | Site Contact - (roman.perri@vumc.org) |
| WIP Warsaw IBD Point Profesor Kierkus Warsaw, | Site Contact - (j.kierkus@wip.waw.pl) |
| Washington University School of Medicine in St. Louis St Louis, Missouri | Site Contact - (smeduchenry@wustl.edu) |
A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)
Chris Korth - clinicaltrials@puretechhealth.com
NCT05829226
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Patients ≥ 18 years of age at the time of obtaining informed consent.
* Patients with morphologically documented primary or secondary AML by the World Health Organization(WHO) criteria, whose disease is relapsed/refractory to at least one line of prior therapy, with or without an allogeneic stem cell transplant and for whom no standard therapy that may provide clinical benefit is available or for patients who decline available standard of care.
* Patients with a documented diagnosis of high-risk myelodysplastic syndrome (MDS), whose disease is relapsed/refractory, post at least one line of treatment based on the revised International Prognostic Scoring System (IPSS-R) and for whom no standard therapy that may provide clinical benefit is available
* Patients are able and willing to comply with study procedures as per protocol, including bone marrowbiopsies.
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Patient must meet the following criteria as indicated on the clinical laboratory tests:
oWhite blood cell (WBC) count at the time of the first dose of \< 25,000/uL. oAspartate aminotransferase or alanine aminotransferase ≤ 3 × upper limit of normal (ULN; ≤ 5.0× ULN if considered to be due to leukemic involvement). oTotal bilirubin ≤ 2 × ULN (≤ 3 × ULN if considered to be due to leukemic involvement orGilbert's syndrome). oCreatinine clearance of ≥ 60 mL/min.
Exclusion Criteria:
* Patient diagnosed with acute promyelocytic leukemia (APL).
* Patient has active malignant tumors other than AML/MDS
* Patient has had HSCT and meets any of the following: has undergone HSCT within the 6- month period prior to the first study dose; has ≥ Grade 2 persistent non-hematological toxicity related to the transplant donor lymphocytes infusion.
* Patient has active graft versus host disease (GVHD) and patients receiving immunosuppressive treatment for GVHD.
* Patient with symptomatic central nervous system (CNS) involvement of leukemia or other CNS diseases related to underlying and secondary effects of malignancy
* Patient has had major surgery within 4 weeks prior to the first study dose.
* Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.
* Patient has any condition which, in the Investigator's opinion, makes the patient unsuitable for study participation. DRUG: LYT-200, DRUG: Venetoclax, DRUG: Azacitidine, DRUG: Decitabine
AML, Adult Recurrent, MDS
AML Recurrent, AML Relapsed, AML Refractory, Hematological Cancer, Gal-9, Immuno-oncology, MDS, MDS High Risk
I'm interested
Share via email
Show 9 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Baptist Health South Florida-Miami Cancer Institute Miami, Florida | |
| Cedars-Sinai Medical Center Beverly Hills, California | |
| Karmanos Cancer Institute Detroit, Michigan | |
| Mass. General Hospital-Harvard Boston, Massachusetts | |
| Norton Healthcare-Norton Cancer Institute Louisville, Kentucky | |
| Rhode Island Hospital Providence, Rhode Island | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| University of California Irvine Medical Center Orange, California | |
| Virginia Commonwealth University Medical Center Richmond, Virginia |
A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss
ctrrecruit@vcu.edu
NCT05382338
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* PRE-ENROLLMENT: Patients must be ≥ 4 years and ≤ 21 years of age at the time of enrollment
* PRE-ENROLLMENT: Patient is suspected to have newly-diagnosed medulloblastoma by institutional diagnosis
* Please note: Patients with a pending result of CSF cytology tests are eligible for NCI-2014-02057 (APEC14B1-Central Nervous System \[CNS\]) and CNS/Medulloblastoma Pre Enrollment Eligibility Screening
* PRE-ENROLLMENT: The patient and/or their parents or legal guardians must have signed informed consent for APEC14B1 Part A - Eligibility Screening and consent for the Molecular Characterization Initiative (MCI)
* PRE-ENROLLMENT: The required specimens are projected to be submitted under APEC14B1-CNS as soon as possible, preferably within 5 days of definitive surgery
* PRE-ENROLLMENT: All patients must have rapid central pathology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1 in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031.
* Note: Patients with a pending result of CSF cytology tests are eligible for the rapid central pathology screening review. Confirmation of CSF negativity is needed for enrollment on the ACNS2031 protocol
* PRE-ENROLLMENT: All patients must have rapid central molecular screening review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1, in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031
* PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central imaging screening review under APEC14B1 prior to study enrollment on ACNS2031 step 1
* Note: Patients must not have metastatic disease on cranial or spinal MRI. Patients with \> 1.5 cm\^2 residual tumor after initial surgical resection may undergo a second surgical resection prior to subsequent therapy to render them eligible for this study. The day of the second resection to remove residual tumor will be regarded as the day of definitive surgery (Day 0) and must be within a month (31 days) of the initial resection
* PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central audiology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1
* Patients must be \>= 4 years and =\< 21 years of age at the time of enrollment
* Patients must be newly diagnosed and have eligibility confirmed by rapid central pathology and molecular screening reviews performed on APEC14B1 and via the Molecular Characterization Initiative
* Average-risk cohort
* Clinico-pathologic criteria:
* M0 disease
* No diffuse anaplastic histology AND
* Molecular criteria:
* SHH, p53wt, GLI2 normal, MYCN normal, no chromosome 14q loss
* Group 3, MYC normal, no isochromosome 17q
* Group 4, no chromosome 11 loss
* Low-risk features cohort
* Clinico-pathologic criteria:
* M0 disease
* No diffuse anaplastic histology AND
* Molecular criteria:
* Group 4, chromosome 11 loss
* Patients must have negative lumbar CSF cytology
* Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF. Ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study. Patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status. Patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated. Patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively
* Patients must have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1. Patients must have =\< 1.5 cm\^2 cross-sectional area of residual tumor. Whole brain MRI with and without gadolinium and spine MRI with gadolinium must be performed
* Patients must weigh \> 10 kg
* Patients must be enrolled, and protocol therapy must be projected to begin, no later than 31 days after definitive diagnostic surgery (day 0)
* Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to enrollment)
* Platelet count \>= 100,000/uL (transfusion independent) (within 7 days prior to enrollment)
* Hemoglobin \>= 8.0 g/dL (may receive red blood cell count \[RBC\] transfusions) (within 7 days prior to enrollment)
* A serum creatinine (within 7 days prior to enrollment) based on age/sex as follows:
* 4 to \< 6 years (age); 0.8 mg/dL (male) 0.8 mg/dL (female)
* 6 to \< 10 years (age); 1 mg/dL (male) 1 mg/dL (female)
* 10 to \< 13 years (age); 1.2 mg/dL (male) 1.2 mg/dL (female)
* 13 to \< 16 years (age); 1.5 mg/dL (male) 1.4 mg/dL (female)
* \>= 16 years (age); 1.7 mg/dL (male) 1.4 mg/dL (female) OR a 24 hour urine Creatinine clearance \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
* Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
* Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment)
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
* Central nervous system function defined as:
* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
* Patients must not be in status epilepticus, a coma or assisted ventilation at the time of study enrollment
* Auditory function defined as:
* Patients must have normal hearing (defined as International Society of Pediatric Oncology \[SIOP\] grade 0) in at least one ear confirmed by rapid central audiology review performed on APEC14B1 prior to enrollment
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are not eligible. Patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible
* Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids
* Patients must not have any known hypersensitivity to STS, sulfates/sulfites, or other thiol agents (e.g., amifostine, n-acetylcysteine, MESNA, and captopril)
* Pregnancy and Breastfeeding:
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation PROCEDURE: Audiometric Test, PROCEDURE: Auditory Brainstem Response, PROCEDURE: Biospecimen Collection, DRUG: Cisplatin, DRUG: Cyclophosphamide, DRUG: Lomustine, PROCEDURE: Magnetic Resonance Imaging, OTHER: Quality-of-Life Assessment, RADIATION: Radiation Therapy, DRUG: Sodium Thiosulfate, OTHER: Survey Administration, DRUG: Vincristine
Childhood Medulloblastoma
I'm interested
Share via email
Show 103 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Corewell Health Children's Royal Oak, Michigan | |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Loma Linda University Medical Center Murrieta, California | |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment (ELFINITY)
Ipsen Clinical Study Enquiries - clinical.trials@ipsen.com
NCT06447168
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Participant has provided written informed consent and agrees to comply with the study protocol.
* Participant with PBC diagnosis.
* Participant for whom the treating physician has decided to start or participants who are currently receiving treatment with commercialized elafibranor.
* If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.
Exclusion Criteria:
* Participant is currently participating or, plans to participate in an investigational drug study or medical device study containing active substance.
* Participant with known hypersensitivity to the product or to any of its excipients.
* Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain. Primary Biliary Cholangitis
I'm interested
Share via email
Show 65 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| (G.I.R.I) GI Research Institute Foundation Vancouver, | |
| A. Gemelli University Hospital, Catholic University of the Sacred Heart Roma, | |
| ASST Grande Ospedale Metropolitano Niguarda Milan, | |
| ASST-Ospedale Papa Giovanni XXIII Bergamo, | |
| Aberdeen Royal Infirmary NHS Grampian Grampian Health Board Aberdeen, | |
| Baylor College of Medicine - Advanced Liver Therapies Houston, Texas | |
| Belfast Health and Social Care Trust - Royal Victoria Hospital Belfast, | |
| Beth Israel Deaconess Medical Center, Liver Research Center Boston, Massachusetts | |
| Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond Richmond, Virginia | |
| Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation Bradford, | |
| Cedars-Sinai Medical Center Beverly Hills, California | |
| Charité Universitätsmedizin Berlin Berlin, | |
| Clemenceau Medical Center Hospital Dubai, | |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| Complexo Hospitalario Universitario de Pontevedra Pontevedra, | |
| DRK Kliniken Berlin Mitte Berlin, | |
| Fondazione Policlinico Universitario Campus Bio-Medico Roma, | |
| Gastro health & Nutrition Katy, Texas | |
| Gastroenterologsiche Studiengesellschaft Herne Herne, | |
| General Hospital of Athens Laiko Athens, | |
| Hospital Clinic de Barcelona (Hospital Clinic i Provincial) Barcelona, | |
| Hospital General Universitario Gregorio Maranon (HGUGM) Madrid, | |
| Hospital Universitario Vall d'Hebron Barcelona, | |
| Hospital de Torrecardenas Almería, | |
| Hospital of the Merciful Brothers Trier Trier, | |
| Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust Hull, | |
| Instituto De Investigacion Marques De Valdecilla (IDIVAL) Santander, | |
| Intermountain Medical Center Murray, Utah | |
| Ippokratio General Hospital of Thessaloniki Thessaloniki, | |
| John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust Oxford, | |
| King's College Hospital NHS Foundation Trust London, | |
| Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt, | |
| Liver Center of Texas Dallas, Texas | |
| London Health Sciences Centre (LHSC) - University Hospital London, | |
| Medical University Innsbruck Innsbruck, | |
| Medical University of South Carolina (MUSC) Charleston, South Carolina | |
| Mediclinic Airport Road Hospital Dubai, | |
| Medizinische Universitaetsklinik Graz Graz, | |
| Northwell Health Inc, Center for Liver Disease and Transplantation Manhasset, New York | |
| Ospedale Garibaldi Nesima Catania, | |
| Ospedale Maggiore Della Carita Novara, | |
| Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust Birmingham, | |
| Queen's Medical Centre - Nottingham University Hospitals NHS Trust Nottingham, | |
| Rashid Hospital Dubai, | |
| Schiff Center for Liver Diseases - University of Miami Miami, Florida | |
| Sheikh Shakhbout Medical City Dubai, | |
| South Denver Gastroenterology,P.C. Englewood, Colorado | |
| Southern California Research Center Coronado, California | |
| Studiengesellschaft BSF Halle, | |
| Texas Digestive Specialists McAllen, Texas | |
| The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital Newcastle, | |
| The Ottawa Hospital - General Campus Ottawa, | |
| UNC Hospitals, The University of North Carolina at Chapel Hill Chapel Hill, North Carolina | |
| Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) Florence, | |
| Universitaet des Saarlandes Homburg, | |
| Universitaetsklinikum Leipzig Leipzig, | |
| University General Hospital of Larissa Larissa, | |
| University General Hospital of Patras Pátrai, | |
| University Hospital of Heraklion Heraklion, | |
| University of Calgary Calgary, Alberta | |
| University of California Davis Medical Center Sacramento, California | |
| Velocity Clinical Research Seattle, Washington | |
| Virginia Commonwealth University Medical Center - West Hospital Richmond, Virginia | |
| Virtua Center for Liver Disease - Cherry Hill Cherry Hill, New Jersey | |
| Yale University School of Medicine North Haven, Connecticut |
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis (ELFIDENCE)
Ipsen Clinical Study Enquiries - clinical.trials@ipsen.com
NCT06016842
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria :
* Male or female participants must be ≥18 years of age at the time of signing the informed consent.
* Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC)
* Participants with cirrhosis at SV1. • Participants must be Child Pugh A or Child Pugh B.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria :
* History or presence of other concomitant liver disease including but not limited to:
* i) Primary sclerosing cholangitis (PSC).
* ii) Autoimmune hepatitis (AIH) by simplified Diagnostic Criteria of the International Autoimmune Hepatitis Group (IAIHG) ≥6, or if treated for an overlap of PBC with AIH, or if there is clinical suspicion and evidence of overlap AIH features, that cannot be explained alone by insufficient response to UDCA.
* iii) Positive hepatitis B surface antigen (HBsAg). Participants with negative HBsAg and positive hepatitis B core antibody (HBcAb) may be eligible if hepatitis B virus deoxyribonucleic acid (HBV DNA) is negative.
* iv) Hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA) (Note: Participants with positive anti-HCV antibody due to previously treated HCV infection, may be enrolled if a confirmatory HCV RNA is undetectable and sustained viral response has been documented).
* v) Alcohol-associated liver disease (ALD).
* vi) Nonalcoholic steatohepatitis (NASH).
* vii) Other chronic liver diseases, such as alpha-1 antitrypsin deficiency.
* History or presence of clinically significant hepatic decompensation, including:
* i) History of liver transplantation, current placement on a liver transplant list, current model for end-stage liver disease including (MELD) 3.0 score \>12 due to hepatic impairment.
* ii) Evidence of complications of cirrhosis, including hepatic decompensation or evidence of significant portal hypertension complications including presence of uncontrolled ascites; history of variceal bleeding or related interventions (e.g. variceal banding, or transjugular intrahepatic portosystemic shunt placement); presence of hepatic encephalopathy Grade 2 or higher per West-Haven criteria; history or presence of spontaneous bacterial peritonitis. Note: participants with low-risk varices (Grade I) without history of bleeding or other treatment may be eligible to enrol.
* iii) Hepatorenal syndrome (HRS) (type I or II ). • vi) Hospitalisation for liver-related complication within 12 weeks prior to SV1.
* Known history of human immunodeficiency virus (HIV) infection or having a positive confirmatory test for HIV type 1 or 2.
* Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
* Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric disease as evaluated by the investigator; other clinically significant conditions that are not well controlled.
* Non-hepatic medical conditions that may diminish life expectancy to \<2 years, including known cancers.
* History of hepatocellular carcinoma.
* Alpha-fetoprotein (AFP) \>20 ng/mL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) imaging suggesting presence of hepatocellular carcinoma.
* Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix.
* Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below: • i) 3 months prior to screening period: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid or nitrofurantoin).
* Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer, prior to the screening period.
i) If the previous study was for an experimental therapy being studied for potential benefit in PBC, and the potential therapeutic agent was proven to have no beneficial effect in PBC and there are no safety concerns, the participant may enrol after 30 days or 5 half-lives from the last dose of the therapeutic agent, whichever is longer.ii) For therapeutic agents being studied for potential benefit in PBC for which it is still unclear if there may be a potential benefit, participants may enrol after 6 months from the last dose of the therapeutic agent.
* Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \>450 msec in males or QTcF \>470 msec in females for participants without bundle branch block. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF \>480 msec would be exclusionary.
* Total bilirubin (TB) \>5x ULN
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>5x ULN at SV1
* Creatinine phosphokinase (CPK) \>2x ULN.
* Platelet count \<50,000/μL
* International normalised ratio (INR) \>1.8 in the absence of anticoagulant therapy.
* Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2 per the Modification of Diet in Renal Disease (MDRD)-6 Study formula at SV1.
* Significant renal disease, including nephritic syndrome, chronic kidney disease (CKD) (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).
* For female participants: known current pregnancy, or has a positive serum pregnancy test, or is breastfeeding.
* Participants unwilling or unable to be abstinent from alcohol during the study.
* History of alcohol abuse, or other substance abuse within 1 year prior to SV1.
* Known hypersensitivity to elafibranor or to any of the excipients of the investigational product(s).
* Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
* Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study.
* Alkaline phosphatase (ALP) ≥10x ULN.
* Albumin \<2.8 g/dL due to impaired hepatic function.
DRUG: Elafibranor, OTHER: Matched 80 mg placebo
Primary Biliary Cholangitis (PBC)
I'm interested
Share via email
Show 177 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Agios Savvas Regional Cancer Hospital Athens, | |
| Algemeen Ziekenhuis Delta Roeselare, | |
| American Research Corporation San Antonio, Texas | |
| American Research Corporation at the Texas Liver Institute San Antonio, Texas | |
| Arizona Liver Health Tucson, Arizona | |
| Arkansas Diagnostic Center, PA Little Rock, Arkansas | |
| Artroscan Ostrava, | |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, | |
| Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia Padova, | |
| Azienda Ospedaliero Universitaria Federico II di Napoli Naples, | |
| Azienda Ospedaliero Universitaria Modena Modena, | |
| Azienda Ospedaliero Universitaria Pisana Pisa, | |
| Baylor Scott & White All Saints Medical Center - Forth Worth Fort Worth, Texas | |
| Bispebjerg Hospital Copenhagen, | |
| Bolanos Clinical Research Pembroke Pines, Florida | |
| Bon Secours St. Mary's Hospital of Richmond, Inc Richmond, Virginia | |
| CHA Bundang Medical Center, CHA University Seongnam-si, | |
| CHU Poitiers Poitiers, | |
| CHU de Nice, Hopital de l'Archet Nice, | |
| Canterbury District Health Board Christchurch, | |
| Cedars-Sinai Medical Center Beverly Hills, California | |
| Central Hospital of Northern Pest - Military Hospital Budapest, | |
| Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez Lille, | |
| Centro Medico Cedid - Centro de Diagnostico Digestivo Viña del Mar, | |
| Centro Medico Colon Córdoba, | |
| Centro de Estudios Clinicos e Investigaciones Medicas (CECIM) Santiago, | |
| Centro de Investigacion Medico Biologica y Terapia Avanzada Jalisco, | |
| Centro de Investigacion y Gastroenterologia SC Mexico City, | |
| Centrul Pentru Studiul Metabolismului Bucharest, | |
| Centrum Medyczne Medyk Sp. z o.o. Sp. K. Rzeszów, | |
| Chung-Ang University Hospital Seoul, | |
| Clinica Universidad Navarra-Sede Madrid Madrid, | |
| Clinique Pasteur Toulouse, | |
| Cluj County Clinical Emergency Hospital Cluj-Napoca, | |
| DIM Centro Medico Buenos Aires, | |
| Diagnostic-Consultative Center Aleksandrovska EOOD Sofia, | |
| Enroll SpA Santiago, | |
| Fakultna nemocnica Nitra Nitra, | |
| Fondazione I.R.C.C.S. Policlinico San Matteo Pavia, | |
| Footscray Hospital, Western Health Footscray, | |
| Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L Buenos Aires, | |
| FutureMeds Warszawa Centrum Warsaw, | |
| FutureMeds sp. z o. o Wroclaw, | |
| Galilee Medical Center Nahariya, | |
| Galilee Medical Center, ZIV Medical Center Nahariya, | |
| Gastro health & Nutrition Katy, Texas | |
| GastroIntestinal Biosciences Los Angeles, California | |
| Gastroenterological Centre Thalion Bratislava, | |
| Gastroenterology Center of the Midsouth Cordova, Tennessee | |
| Gastromedica Srl Iași, | |
| GeneIppokratio General Hospital of Thessaloniki Thessaloniki, | |
| General Hospital of Athens Laiko Athens, | |
| General Oncological Hospital of Kifisia Oi Agioi Anargyroi Athens, | |
| Gent University Hospital Ghent, | |
| Hadassah University Hospital (HUH) - Ein-Kerem Jerusalem, | |
| Hallym University Kangnam Sacred Heart Hospital Seoul, Seoul-teukbyeolsi [seoul] | |
| Hanyang University Seoul Hospital Seoul, | |
| Hepato-Gastroenterologie HK, s.r.o. Hradec Králové, | |
| Hopital Paul-Brousse - APHP Villejuif, | |
| Hopital Pitie-Salpetriere - APHP Paris, | |
| Hopital Saint Joseph - Marseille Marseille, | |
| Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse Lyon, | |
| Hospital Britanico de Buenos Aires Ciudad de Buenos Aires, Buenos Aires | |
| Hospital Clinic i Provincial de Barcelona Barcelona, | |
| Hospital Clinico de la Pontificia Universidad Catolica de Chile Santiago, | |
| Hospital Dr. Nelio Mendonca Funchal, | |
| Hospital El Cruce Florencio Varela, Buenos Aires, | |
| Hospital Espanol De Mendoza Godoy Cruz, Mendoza, Mendoza Province | |
| Hospital General Universitario Gregorio Maranon (HGUGM) Madrid, | |
| Hospital Henri Mondor Créteil, | |
| Hospital Queen Elizabeth II Sabak Bernam, | |
| Hospital Sultanah Aminah Johor Bahru, Johor | |
| Hospital Universitario Austral Pilar, | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Miguel Servet Zaragoza, | |
| Hospital Universitario Puerta de Hierro de Majadahonda Majadahonda, | |
| Hospital Universitario Rio Hortega Valladolid, | |
| Hospital Universitario Vall d'Hebron Barcelona, | |
| Hospital Universitario Virgen de la Victoria Málaga, | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital Universitario y Politécnico La Fe Valencia, Valencia | |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo São Paulo, | |
| Hospital de Base - Centro Integrado de Pesquisa ( CIP ) São Paulo, | |
| Hospital de Clinicas de Porto Alegre (HCPA) Porto Alegre, | |
| Hospital de Montecelo Pontevedra, | |
| Hospital of Lithuanian University of Health Sciences Kaunas Kaunas, | |
| Houston Methodist Cancer Center Houston, Texas | |
| Huron Gastroenterology Associates - Center for Digestive Care Ypsilanti, Michigan | |
| Impact Research Tx Waco, Texas | |
| Inha University Hospital Incheon, | |
| Inje University Ilsan Paik Hospital Goyang, | |
| Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli Sabadell, | |
| Institute for Clinical and Experimental Medicine - IKEM Prague, | |
| Institute of Gastroenterology and Liver Diseases - Soroka University Medical Center Beersheba, | |
| Instituto D'Or de Pesquisa e Ensino - Hospital Aliança Salvador, | |
| International Center for Research Tampa, Florida | |
| Keimyung University Dongsan Hospital Daegu, | |
| Kenezy County Hospital Debrecen, | |
| Korea University Ansan Hospital Ansan-si, Kyǒnggi-do | |
| Korea University Guro Hospital Seoul, | |
| Krajská nemocnice Liberec Liberec, | |
| Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds Krakow, | |
| Krakowskie Centrum Medyczne Sp.z.o.o. - FutureMeds Małogoskie, | |
| Kyungpook National University Hospital (KNUH) Junggu, | |
| Liver Associates of Texas Houston, Texas | |
| Liver Center of Texas Dallas, Texas | |
| Louisiana Research Center, LLC Shreveport, Louisiana | |
| Medical Care & Research Yucatán, | |
| Medical University of South Carolina Charleston, South Carolina | |
| Medrise Sp. z o.o. Lublin, | |
| Medstar Georgetown Transplant Institute University Hospital (MGUH) Columbia, Washington | |
| Methodist Transplant Physicians Dallas, Texas | |
| Monash University - Monash Health -Monash Medical Centre Melbourne, | |
| NUPEC Cardio Belo Horizonte, Minas Gerais | |
| NYU Langone Gastroenterology and Hepatology Associates New York, New York | |
| NZOZ Twoje Zdrowie EL Sp. z o.o. Elblag, | |
| Nepean Clinical School Kingswood, | |
| Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poliklinika Doktora Bessera Sosnowiec, | |
| Nzoz Centrum BadanKlinicznych Wroclaw, | |
| Ospedale San Gerardo Monza, | |
| Ospedale casa sollievo della sofferenza San Giovanni Rotondo, | |
| Peak Gastroenterology Associates Colorado Springs, Colorado | |
| PlanetMed Sp. z o.o. Wroclaw, | |
| Pusan National University Hospital (PNUH) Busan, | |
| Rabin Medical Center - Beilinson Hospital - Liver Institute Petah Tikva, | |
| Rambam Health Care Campus (RHCC) Haifa, | |
| Research Site S.R.O. Pilsen, | |
| Rocky Mountain Gastroenterology Littleton, Colorado | |
| Rush University Medical Center - University Cardiovascular Surgeons Dallas, Texas | |
| Samsung Medical Center Seoul, Gangnam-gu | |
| Sana S.R.L Bucharest, | |
| Seoul National University Bundang Hospital (SNUBH) Seoul, | |
| Seoul National University Hospital Seoul, Seoul Teugbyeolsi | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Shaare Zedek Medical Center Jerusalem, | |
| South Denver Gastroenterology, P.C. Englewood, Colorado | |
| Southern California Research Center Coronado, California | |
| Southwest Gastroenterology Associates, PC (SWGA) Albuquerque, New Mexico | |
| Spital Clinic Dr I Cantacuzino Bucharest, | |
| St George Hospital Kogarah, New South Wales | |
| Sunshine Coast University Hospital Birtinya, | |
| Szegedi Tudomanyegyetem AOK, I. sz Belgyogyaszati Klinika Szeged, | |
| Szpital Uniwersytecki w Krakowie Krakow, | |
| Texas Clinical Research Institute Arlington, Texas | |
| The Catholic University of Korea Daejeon St.Mary's Hospital Daejeon, | |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul, Seoul-teukbyeolsi [seoul] | |
| The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, | |
| The Catholic University of Korea, Uijeongbu St. Mary's Hospital Uijeongbu-si, | |
| Tokuda Hospital, Dept. of Internal Medicine Sofia, | |
| Unidade Local de Saúde de Trás-os-Montes e Alto Douro, E. P. E Vila Real, | |
| Universidad De Los Andes Las Condes, | |
| Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB) São Paulo, | |
| Universidade Federal de Goias Goiânia, | |
| Universitair Ziekenhuis Antwerpen Antwerp, | |
| University Health Network (UHN) - Toronto General Hospital (TGH) - Toronto General Research Institute (TGRI) Toronto, | |
| University Hospital City Clinic Cancer Center Sofia, | |
| University Of Miami School Of Medicine, Center For Liver Diseases Miami, Florida | |
| University of Alberta - Faculty of Medicine & Dentistry - The Centre of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR) Edmonton, | |
| University of California Davis Medical Center Sacramento, California | |
| University of California Los Angeles Los Angeles, California | |
| University of Chile Clinical Hospital (Hospital Clinico de la Universidad de Chile) Santiago, | |
| University of Colorado Aurora, Colorado | |
| University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic Kansas City, Kansas | |
| University of Malaya Medical Centre Kuala Lumpur, | |
| University of Michigan Health System Ann Arbor, Michigan | |
| University of Pittsburgh Pittsburgh, Pennsylvania | |
| University of Texas Southwestern Medical Center at Dallas Dallas, Texas | |
| University of Virginia Medical Center Charlottesville, Virginia | |
| Univerzitna nemocnica L. Pasteura Kosice Košice, | |
| Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego Katowice, | |
| Velocity Clinical Research at Liver Institute Northwest Seattle, Washington | |
| Vilnius University Hospital Santaros Klinikos Vilnius, | |
| Virginia Commonwealth University Medical Center - West Hospital Richmond, Virginia | |
| Waikato Hospital Hamilton, Waikato Region | |
| Westmead Hospital Westmead, | |
| Ziekenhuis Oost-Limburg Genk, | |
| hospital Italiano de Buenos Aires Buenos Aires, |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com
NCT06025578
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria
* Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
* If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
* If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
* Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
* Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
* Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken these medications within 28 days prior to screening.
* Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
* Men who are sexually active with women of childbearing potential agree to use male barrier contraception.
Exclusion Criteria
* Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
* History of stroke or transient ischemic attack within 3 months prior to screening.
* Participants who exhibit symptoms of heart failure at rest.
* Participants who have a current malignancy; a previous malignancy with less than 2 years free of recurrence; and a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
* Use of systemic corticosteroids equivalent to prednisone \> 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
* Other protocol-defined Inclusion/Exclusion criteria apply.
DRUG: BMS-986278, DRUG: BMS-986278 Placebo
Progressive Pulmonary Fibrosis
BMS-986278, LPA1 antagonist, Pulmonary fibrosis, Interstitial lung disease, Rheumatoid Arthritis, Connective Tissue Disorders, Sarcoidosis, Scleroderma, Fibrosis, Antifibrotic therapy
I'm interested
Share via email
Show 536 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| "Corfu General Hospital ""St. IRINI""" Corfu, | |
| "Ospedale ""Gian Battista Morgagni - Luigi Pierantoni"" di Forli" Forlì, | |
| ACE Hospital & Research Center Pune, Maharashtra | |
| AORN - Ospedali dei Colli Ospedale V. Monaldi Napoli, | |
| Ajou University Hospital Suwon, | |
| All India Institute of Medical Sciences (AIIMS) - New Delhi New Delhi, National Capital Territory of Delhi | |
| Alliance Pulmonary Group Guaynabo, PR | |
| Amsterdam UMC - Locatie VUMC - Pulmonale Hypertensie (PH) Kenniscentrum Amsterdam, | |
| AnMed Health Oglesby Center - AnMed Health Pulmonary and Sleep Medicine Anderson, South Carolina | |
| Anhui Medical University - Anhui Chest Hospital Hefei, AH | |
| Anhui Provincial Hospital Hefei City, Anhui Province, Anhui | |
| Asan Medical Center (AMC) Seoul, | |
| Aso Iizuka Hospital Iizuka, Fukuoka | |
| Assistance Publique Hopitaux de Marseille - Hopital Nord Marseille, | |
| Asst Papa Giovanni XXIII Bergamo, Lombardy | |
| Asthma Bhawan Jaipur, Rajasthan | |
| Athens Medical Center Marousi, Attica | |
| Avanza Medical Research Center Pensacola, Florida | |
| Azienda Ospedaliera San Paolo Milan, | |
| Azienda Ospedaliera Universitaria - Universita di Sassari Sassari, | |
| Azienda Ospedaliero - Universitaria di Modena Policlinico Modena, Emilia-Romagna | |
| Azienda Ospedaliero Universitaria Pisana Pisa, | |
| Azienda Ospedaliero Universitaria delle Marche Ancona, | |
| Azienda Ospedaliero-Universitaria Careggi Florence, | |
| Baylor University Medical Center at Dallas Dallas, Texas | |
| Beaumont Hospital, Royal Oak Royal Oak, Michigan | |
| Beijing Chaoyang Hospital, Capital Medical University Beijing, Beijing Municipality | |
| Beijing Friendship Hospital, Capital Medical University Beijing, | |
| Ben-Gurion University of the Negev - Soroka University Medical Center Beersheba, D | |
| Bioreuma Concepción, Bio Bio | |
| C.I.C. Mauricie Inc. Trois-Rivières, Quebec | |
| CEC Centros Estudios Clinicos Santiago, RM | |
| CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo Do Campo/SP, | |
| CENRESIN - Centro Respiratorio Integral Quillota, Región de Valparaíso | |
| CHRU de Tours - Hôpital Bretonneau Tours, | |
| CHU Dijon - Hôpital François Mitterrand Dijon, | |
| CHU Hopitaux de Bordeaux - Hopital Haut-Leveque Pessac, | |
| CHU UCL Namur - Mont-Godinne Yvoir, Namur | |
| CHU de Brest - Hôpital Cavale Blanche Brest, | |
| CHU de Nantes - Hôpital Nord Laennec Nantes, Pays de la Loire Region | |
| CHU de Nice - Hopital Pasteur Nice, | |
| CICUM San Miguel Guadalajara, Jalisco | |
| Carmel Medical Center Haifa, | |
| Center Hospital of the National Center for Global Health and Medicine Shinjyu-Ku, | |
| Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) Grenoble, Auvergne-Rhône-Alpes | |
| Centre Hospitalier Universitaire d'Angers Angers, | |
| Centre Hospitalier Universitaire de Liege - Sart Tilman Liège, | |
| Centro Medico Santa Maria Barra Mansa, Rio de Janeiro | |
| Centro Medico de Enfermedades Respiratorias Florida, B | |
| Centro Respiratorio Quilmes Quilmes, Provincia de Buenos Aires, B | |
| Centro Respiratorio de México México, DIF | |
| Centro de Estudos de Pneumologia da Faculdade de Medicina do ABC (CEPFMABC) Santo André, São Paulo | |
| Centro de Investigacion Clinica de Oaxaca (CICLO) Oaxaca City, Oaxaca | |
| Centro de Investigacion Clinica en Mexico (CIMeT) Guadalajara, Jalisco | |
| Centro de Investigacion Curico Curicó, Maule Region | |
| Centro de Investigacion Medica Aguascalientes Aguascalientes, | |
| Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA) Guadalajara, | |
| Centro de Investigacion de Enfermedades Respiratorias e Imunologicas (CIERI) Viña del Mar, Región de Valparaíso | |
| Centro de Investigaciones Metabólicas (CINME) Buenos Aires, | |
| Centro de Investigación Clínica Chapultepec S.A. de C.V. Morelia, Michoacán | |
| Centro de Investigación del Maule Talca, | |
| Centrum Medycyny Oddechowej Bialystok, Podlaskie Voivodeship | |
| Chang Gung Medical Foundation - Kaohsiung Branch Kaohsiung City, Kao-Hsiung | |
| Changhua Christian Hospital Changhua, | |
| Chiba University Hospital Chiba, Chiba, | |
| China Medical University Hospital Taichung, | |
| Christiana Care Pulmonary Associates - Newark Newark, Delaware | |
| Clinica 25 de Mayo Mar del Plata, B | |
| Clinica Cardio Vid Medellín, ANT | |
| Clinica Internacional - Sede San Borja San Borja, Lima region | |
| Clinica La Luz - Lima Lima, | |
| Clinica Providencia San Miguel, LIM | |
| Clinica Ricardo Palma Lima, LIM | |
| Clinica Universidad de Navarra Pamplona, | |
| Clinica Universidad de los Andes Santiago, | |
| Cliniques Universitaires Saint-Luc Brussels, | |
| Clínica Belén Piura, PIU | |
| Clínica Universidad de Navarra -Madrid Madrid, | |
| Clínica de día Jockey Salud Lima, LIM | |
| Coastal Pulmonary & Critical Care, P.L.C. St. Petersburg, Florida | |
| Connolly Hospital Blanchardstown Dublin, | |
| Consultorios Médicos del Buen Ayre Capital Federal, | |
| Diex Recherche - Trois-Rivieres Trois-Rivières, Quebec | |
| Duke University Medical Center Durham, North Carolina | |
| Eastern Health Box Hill, Victoria | |
| Ege Universitesi Tip Fakultesi Hastanesi (Ege University Medical Faculty Hospital) Izmir, | |
| Erasmus MC - Centrum voor Interstitiele Longziekten Rotterdam, South Holland | |
| Escola Paulista de Medicina São Paulo, | |
| Fachkrankenhaus Coswig GmbH Coswig, | |
| Florida Lung, Asthma and Sleep Specialists - Celebration Celebration, Florida | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fondazione IRCCS San Gerardo dei Tintori Monza, | |
| Fondazione Policlinico Universitario Agostino Gemelli Roma, | |
| Fortis Hospital Mohali Mohali, Punjab | |
| Fujita Health University Hospital Aichi, | |
| Fukuoka University - Chikushi Hospital Chikushino-shi, Fukuoka | |
| Fundacion Enfisema - Instituto Ave Pulmo Mar del Plata, Buenos Aires | |
| Fundacion Respirar Buenos Aires, | |
| Fundacion Santa Fe de Bogota Bogotá, | |
| Fundación Neumológica Colombiana Bogotá, DC | |
| Gachon University - Gil Medical Center Incheon, | |
| Gallipoli Medical Research Centre - Clinical Trials Unit (CTU) Greenslopes, Queensland | |
| General Hospital of Ningxia Medical University Yinchuan, | |
| General Hospital of Thessaloniki - Papageorgiou Thessaloniki, | |
| Gentofte Hospital Hellerup, | |
| Getwell Hospital and Research Institute - Lungs Care Nagpur, Maharashtra | |
| Giromed Institute, SLP Barcelona, | |
| Grant Medical Foundation - Ruby Hall Clinic Pune, | |
| Green City Hospital Bhopal, Madhya Pradesh | |
| Guy's and St Thomas' NHS Foundation Trust - Royal Brompton Hospital London, Greater London | |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Győr, Győr-Moson-Sopron | |
| HELIOS Klinikum Emil von Behring Berlin, State of Berlin | |
| Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem Jerusalem, | |
| Hamamatsu University Hospital Hamamatsu, | |
| Hangzhou First People's Hospital Hangzhou, | |
| Health SURA Calle 100 Bogotá, DC | |
| Health SURA Chipichape Santiago de Cali, VAC | |
| Healthy Medical Center Zipaquirá, Cundinamarca | |
| Helios Hanseklinikum Stralsund Stralstund, | |
| Helsinki University Hospital Heart and Lung Center Helsinki, Etelae-Suomen Laeaeni | |
| Henan provincial people's hospital Zhengzhou, | |
| Hiroshima Prefectural Hospital Hiroshima, Hirohima-ken | |
| Hokkaido University Hospital Sapporo, Hokkaido | |
| Hopital Avicenne Bobigny, | |
| Hopitaux Universitaires de Geneve (HUG) Geneva, Canton of Geneva | |
| Hospices Civils de Lyon Bron, Auvergne-Rhône-Alpes | |
| Hospital Alemao Oswaldo Cruz (HAOC) - Centro de Oncologia (Oncology Center) São Paulo, | |
| Hospital CUF Tejo Lisbon, | |
| Hospital Canselor Tuanku Muhriz UKM Cheras, Kuala Lumpur | |
| Hospital Clinic de Barcelona Barcelona, | |
| Hospital Clinico San Carlos Madrid, | |
| Hospital Clinico Universitario Madrid, | |
| Hospital Dia do Pulmão Blumenau, Santa Catarina | |
| Hospital Ernesto Dornelles (HED) Porto Alegre, Rio Grande do Sul | |
| Hospital Madre Teresa Belo Horizonte, Minas Gerais | |
| Hospital Nacional Cayetano Heredia Lima, | |
| Hospital Sao Lucas da PUCRS Porto Alegre, Rio Grande do Sul | |
| Hospital Umum Sarawak Kuching, | |
| Hospital Universitari de Bellvitge (IDIBELL) Barcelona, | |
| Hospital Universitario Central de Asturias Oviedo, Principality of Asturias | |
| Hospital Universitario Fundacion Jimenez Diaz Madrid, | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Marqués de Valdecilla Santander, | |
| Hospital Universitario Puerta De Hierro - Majadahonda Madrid, | |
| Hospital Universitario San Ignacio Bogota, Cundinamarca | |
| Hospital Universitario Vall d'Hebron Barcelona, | |
| Hospital Universitario Virgen de la Victoria Málaga, | |
| Hospital Universitario de La Princesa Madrid, | |
| Hospital das Clínicas da Universidade Federal de Minas Gerais (UFMG) Belo Horizonte, Minas Gerais | |
| Hospital de Santa Marta Lisbon, | |
| Huadong Hospital Affiliated to Fudan University Shanghai, | |
| Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital Cottingham, Yorkshire and the Humber | |
| Hôpital Bichat - Claude-Bernard Paris, | |
| Hôpital Larrey Toulouse, | |
| Ibamedica Santa Fe, | |
| Icahn School of Medicine at Mount Sinai New York, New York | |
| Inje University Busan Paik Hospital BusanjinGu, Busan Gwang'yeogsi | |
| Inje University Haeundae Paik Hospital Busan, | |
| Inje University Ilsan Paik Hospital Goyang, | |
| Inselspital - Universitaetsklinik Bern für Pneumologie Bern, Canton of Bern | |
| Institut Perubatan Respiratori Kuala Lumpur, | |
| Institute for Respiratory Health Nedlands, Western Australia | |
| Institute of Science Tokyo Hospital Tokyo, Bunkyo-ku, | |
| Instituto De Enfermedades Respiratorias E Investigacion Medica (IERIM) San Juan Bautista, Buenos Aires | |
| Instituto Medico DAMIC Córdoba, | |
| Instituto Medico INSARES SA Mendoza, M | |
| Instituto Medico de la Fundacion de Estudios Clínicos Rosario, S | |
| Instituto Nacional del Tórax Santiago, | |
| Instituto Neumologico del Oriente Floridablanca, Santander Department | |
| Investigacion Clinica por la Slaud de Cordoba - SALUDCOR Córdoba, Veracruz | |
| Investigaciones en Patologias Respiratorias San Miguel de Tucuman, Tucumán, T | |
| Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi Topkapı, | |
| Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) Palermo, | |
| Jehangir Clinical Development Center Pune, Maharashtra | |
| Jichi Medical University Hospital Tochigi, | |
| Jizankai Medical Foundation Tsuboi Cancer Center Hospital Koriyama-shi, Fukushima | |
| Juntendo University Hospital Bunkyo-ku, Tokyo | |
| K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre Belagavi, Karnataka | |
| Kameda Medical Center - Kameda Clinic Kamogawa-shi, Chiba | |
| Kanagawa Cardiovascular and Respiratory Center Kanagawa, Yokohama, | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | |
| Kaplan Medical Center Rehovot, | |
| Keio University Hospital Shinjuku-Ku, | |
| Kepler Universitatsklinikum Linz, Upper Austria | |
| Kindai University Hospital Sakai, Osaka | |
| King George's Medical University Lucknow, Uttar Pradesh | |
| Kitasato University Hospital Sagamihara, Kanagawa | |
| Klinikum der Universitat Munchen Munich, | |
| Kobe City Medical Center General Hospital Kobe, | |
| Krankenhaus Hietzing Vienna, | |
| Krankenhaus der Augustinerinnen- Klinik fuer Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin Cologne, Northwest | |
| Kurume University Hospital Kurume, | |
| Kyorin University Hospital Mitaka, Tokyo | |
| Kyushu University Hospital Fukuoka, Fukuoka, | |
| Layrek Clinical Research Tulsa, Oklahoma | |
| Leeds Teaching Hospitals NHS Trust Leeds, | |
| Leids Universitair Medisch Centrum Leiden, | |
| Local Institution - 0004 ABB, Buenos Aires F.D. | |
| Local Institution - 0007 Santiago, Santiago Metropolitan | |
| Local Institution - 0013 Clearwater, Florida | |
| Local Institution - 0014 Strasbourg, Alsace | |
| Local Institution - 0015 Paris, | |
| Local Institution - 0019 Villejuif, Val-de-Marne | |
| Local Institution - 0024 Sint-Niklaas, Oost-Vlaanderen | |
| Local Institution - 0028 Ravenna, Emilia-Romagna | |
| Local Institution - 0031 Orbassano, Piedmont | |
| Local Institution - 0033 Wenzhou, Zhejiang | |
| Local Institution - 0036 Aviano, Friuli Venezia Giulia | |
| Local Institution - 0037 Portland, Oregon | |
| Local Institution - 0040 Evanston, Illinois | |
| Local Institution - 0043 Goyang-si, Kyǒnggi-do | |
| Local Institution - 0045 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0049 Kansas City, Kansas | |
| Local Institution - 0050 Grand Rapids, Michigan | |
| Local Institution - 0053 Burlington, Ontario | |
| Local Institution - 0059 Los Angeles, California | |
| Local Institution - 0066 Massillon, Ohio | |
| Local Institution - 0068 Seoul, Seoul-teukbyeolsi [Seoul] | |
| Local Institution - 0069 Bengaluru, Karnataka | |
| Local Institution - 0070 New Delhi, National Capital Territory of Delhi | |
| Local Institution - 0071 Mumbai, Maharashtra | |
| Local Institution - 0073 Ahmedabad, Gujarat | |
| Local Institution - 0075 Chengdu, Sichuan | |
| Local Institution - 0078 Howrah, West Bengal | |
| Local Institution - 0079 Nanchang, Jiangxi | |
| Local Institution - 0080 Iowa City, Iowa | |
| Local Institution - 0090 Bordeaux, Aquitaine | |
| Local Institution - 0093 Salamanca, | |
| Local Institution - 0097 Nagpur, Maharashtra | |
| Local Institution - 0099 Sherbrooke, Quebec | |
| Local Institution - 0102 Québec, Quebec | |
| Local Institution - 0106 Bergen, Hordaland | |
| Local Institution - 0107 Wichita, Kansas | |
| Local Institution - 0108 Wuhan, Hubei | |
| Local Institution - 0110 Glasgow, Glasgow City | |
| Local Institution - 0111 Qingdao, Shandong | |
| Local Institution - 0125 Ōsaka-sayama, Osaka | |
| Local Institution - 0131 Busan, Pusan-Kwangyǒkshi | |
| Local Institution - 0142 Pembroke Pines, Florida | |
| Local Institution - 0153 Chicago, Illinois | |
| Local Institution - 0166 Sakai, Osaka | |
| Local Institution - 0169 Badalona, B | |
| Local Institution - 0181 Majadahonda, Madrid, Comunidad de | |
| Local Institution - 0186 Rochester, New York | |
| Local Institution - 0197 Hamamatsu, Shizuoka | |
| Local Institution - 0200 Kurashiki, Okayama-ken | |
| Local Institution - 0219 Bydgoszcz, | |
| Local Institution - 0220 Lublin, Lublin Voivodeship | |
| Local Institution - 0224 Oaxaca City, Oaxaca | |
| Local Institution - 0228 Bogotá, Cundinamarca | |
| Local Institution - 0230 Daytona Beach, Florida | |
| Local Institution - 0238 Esslingen am Neckar, Baden-Wurttemberg | |
| Local Institution - 0241 Ulm, | |
| Local Institution - 0245 Nagpur, Maharashtra | |
| Local Institution - 0247 Nanchang, Jiangxi | |
| Local Institution - 0251 Linhai, Zhejiang | |
| Local Institution - 0252 Hangzhou, Zhejiang | |
| Local Institution - 0256 Xuzhou, Jiangsu | |
| Local Institution - 0259 Chongqing, Chongqing Municipality | |
| Local Institution - 0275 Portland, Oregon | |
| Local Institution - 0276 Anjo, Aichi-ken | |
| Local Institution - 0294 Stuttgart, Baden-Wurttemberg | |
| Local Institution - 0299 Heidelberg,VIC, Victoria | |
| Local Institution - 0303 Murdoch, Western Australia | |
| Local Institution - 0304 Salvador, Estado de Bahia | |
| Local Institution - 0331 Chūō, Yamanashi | |
| Local Institution - 0332 Brest, Finistère | |
| Local Institution - 0335 Saint-Cloud, Hauts-de-Seine | |
| Local Institution - 0338 Amsterdam, | |
| Local Institution - 0346 Chicago, Illinois | |
| Local Institution - 0347 Osaka, | |
| Local Institution - 0351 Bristol, BST | |
| Local Institution - 0353 South Shields, STY | |
| Local Institution - 0356 Birtinya, Queensland | |
| Local Institution - 0360 Southport, Queensland | |
| Local Institution - 0365 Frankston, Victoria | |
| Local Institution - 0367 Dunedin, Otago | |
| Local Institution - 0371 Nagoya, Aichi-ken | |
| Local Institution - 0378 Weston, Florida | |
| Local Institution - 0381 London, LND | |
| Local Institution - 0383 Augsburg, Bavaria | |
| Local Institution - 0385 Wels, Upper Austria | |
| Local Institution - 0391 Oslo, | |
| Local Institution - 0392 Sofia, | |
| Local Institution - 0395 Ioannina, Ípeiros | |
| Local Institution - 0397 Chaïdári, Attikí | |
| Local Institution - 0398 Alexandroupoli, Anatolikí Makedonía Kai Thráki | |
| Local Institution - 0407 Ahmedabad, Gujarat | |
| Local Institution - 0411 Mexico City, Mexico City | |
| Local Institution - 0412 A Coruña, A Coruña [La Coruña] | |
| Local Institution - 0416 Riyadh, | |
| Local Institution - 0420 Sarıçam, Adana | |
| Local Institution - 0422 Ankara, | |
| Local Institution - 0423 Kitakyushu-shi, Fukuoka | |
| Local Institution - 0424 Suzhou, Jiangsu | |
| Local Institution - 0427 Singapore, Central Singapore | |
| Local Institution - 0436 Edgewood, Kentucky | |
| Local Institution - 0437 Kansas City, Missouri | |
| Local Institution - 0440 Osijek, | |
| Local Institution - 0441 Deagu, Taegu-Kwangyǒkshi | |
| Local Institution - 0445 Riyadh, Riyadh Region | |
| Local Institution - 0456 Seongnam, Kyǒnggi-do | |
| Local Institution - 0457 Nagpur, Maharashtra | |
| Local Institution - 0462 Auckland, | |
| Local Institution - 0463 Hermosillo, Sonora | |
| Local Institution - 0464 Pilea Chortiatis, Thessaloniki | |
| Local Institution - 0465 Tacoma, Washington | |
| Local Institution - 0466 Pittsburgh, Pennsylvania | |
| Local Institution - 0467 Darlinghurst, New South Wales | |
| Local Institution - 0468 Santiago, | |
| Local Institution - 0469 Rock Hill, South Carolina | |
| Local Institution - 0470 Santa Cruz de Tenerife, | |
| Local Institution - 0471 Coimbatore, Tamil Nadu | |
| Local Institution - 0473 Graz, Styria | |
| Local Institution - 0476 Engenho Velho da Federação, Salvador | |
| Local Institution - 0478 Sankt Gallen, | |
| Local Institution - 0479 Bangkok, | |
| Local Institution - 0481 Bangkok Noi, Bangkok | |
| Local Institution - 0483 Kajang, Selangor | |
| Local Institution - 0485 Chiang Mai, Chiang Mai | |
| Local Institution - 0487 Solna, Stockholms Län [se-01] | |
| Local Institution - 0488 Madrid, | |
| Local Institution - 0491 Badalona, Barcelona [Barcelona] | |
| Local Institution - 0499 Groningen, | |
| Local Institution - 0503 Cottbus, | |
| Local Institution - 0505 Erlangen, Bavaria | |
| Local Institution - 0512 Bayreuth, Bavaria | |
| Local Institution - 0514 Saint-Charles-Borromée, Quebec | |
| Local Institution - 0516 Houston, Texas | |
| Local Institution - 0517 Miami, Florida | |
| Local Institution - 0520 Lodz, | |
| Local Institution - 0526 Tucson, Arizona | |
| Local Institution - 0527 Jaipur, Rajasthan | |
| Local Institution - 0528 Hyderabad, Telangana | |
| Local Institution - 0529 Greenfield Park, Quebec | |
| Local Institution - 0533 Konstanz, Baden-Wurttemberg | |
| Local Institution - 0535 Newport Beach, California | |
| Local Institution - 0536 Changsha, | |
| Loyola University Health System Maywood, Illinois | |
| Lungenfachklinik Immenhausen Immenhausen, | |
| M Health Fairview University of Minnesota Medical Center - CSC - Center for Lung Science and Health Minneapolis, Minnesota | |
| MICS Centrum Medyczne Bydgoszcz Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Marengo CIMS Hospital Ahmedabad, Gujarat | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mater Misericordiae Limited South Brisbane, Queensland | |
| Matsusaka Municipal Hospital Matsusaka, | |
| Max Super Specialty Hospital, Saket - West Block - A Unit of Max Healthcare Institute Limited New Delhi, National Capital Territory of Delhi | |
| McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location Houston, Texas | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical Care & Research S.A. de C.V. Mérida, Yucatán | |
| Medicos Internistas de Caldas Manizales, CL | |
| Mercy St. Vincent Medical Center Toledo, Ohio | |
| Meris Clinical Research Brandon, Florida | |
| Metroplex Pulmonary and Sleep Center McKinney, Texas | |
| Midland Healthcare & Research Center Lucknow, | |
| Myongji Hospital Goyang-si, Gyeonggi-do | |
| Mérida Investigación Clínica Mérida, Yucatán | |
| NHS Lothian - Royal Infirmary of Edinburgh Edinburgh, EDH | |
| NHS Tayside Dundee, DND | |
| NZOZ Przychodnia Vitamed Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Nagasaki University Hospital Nagasaki, | |
| Nagoya University Hospital Nagoya, | |
| Nanfang Hospital of Southern Medical University Guangzhou, Guangdong | |
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing, JS | |
| National Hospital Organization - Yamaguchi-Ube Medical Center Ube-shi, Yamaguchi | |
| National Hospital Organization Himeji Medical Center Himeji, | |
| National Hospital Organization Ibarakihigashi National Hospital Naka-gun, Gunma | |
| National Hospital Organization Kinki-Chuo Chest Medical Center Osaka, Sakai, | |
| National Hospital Organization Kyushu Medical Center Fukuoka, | |
| National Jewish Health Denver, Colorado | |
| National Taiwan University Hospital - The National Center of Excellence for Clinical Trial Taipei, | |
| National Taiwan University Hospital Yun-Lin Branch Yunlin County, | |
| Nil Ratan Sircar Medical College and Hospital Kolkata, West | |
| Nippon Medical School Hospital Bunkyo-Ku, Tokyo | |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Norton Healthcare, Inc. Louisville, Kentucky | |
| OU Health Sciences Center - OU Health Physicians - Cardiology, Pulmonary & Vascular Medicine Clinic Oklahoma City, Oklahoma | |
| Oaxaca Site Management Organization (OSMO) Oaxaca City, Oaxaca | |
| Odense Universitetshospital - Svendborg Sygehus Odense C, Region Syddanmark | |
| Omega Research Consultants LLC DeBary, Florida | |
| OncoCentro - Vina del Mar Viña del Mar, | |
| Osaka Medical and Pharmaceutical University Hospital Osaka, | |
| Ospedale Colonnello D'Avanzo Foggia Foggia, | |
| Ospedale Policlinico di Siena Siena, | |
| Our Lady of Lourdes Hospital - Drogheda Drogheda, LH | |
| Oxford University Hospitals NHS Trust - Churchill Hospital Oxford, | |
| Papworth Hospital NHS Foundation Trust Cambridge, Cambridgeshire | |
| Peking Union Medical College Hospital Beijing, Beijing Municipality | |
| Peking University Shenzhen Hospital Shenzhen, Guangdong | |
| Penn Medicine - Perelman Center for Advanced Medicine Philadelphia, Pennsylvania | |
| Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania | |
| Peterborough City Hospital Peterborough, | |
| Policlínica Piquet Carneiro, Universidade do Estado do Rio de Janeiro Rio de Janeiro, Rio de Janeiro | |
| Pulmonology Associates - Wynnewood Wynnewood, Pennsylvania | |
| Pulmonology, Sleep, Asthma & Allergy Center of Dublin Dublin, Georgia | |
| Qilu Hospital of Shandong University Jinan, | |
| Rabin Medical Center - Hasharon Hospital Petah Tikva, | |
| Rambam Health Care Campus - Pulmonology Haifa, | |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine - South Branch Shanghai, SH | |
| Renmin Hospital of Wuhan University Wuhan, | |
| Renown Regional Medical Center Reno, Nevada | |
| Respira Salud Clinica Integral Godoy Cruz, M | |
| Rigshospitalet Copenhagen, | |
| Royal Prince Alfred Hospital Camperdown, New South Wales | |
| SALK - Universitatsklinik Fur Pneumologie/ Lungenheilkunde Landeskrankenhaus Salzburg, Salzburger Land | |
| Saiseikai Kumamoto Hospital Kumamoto, | |
| Santa Casa de Misericórdia de Porto Alegre - Hospital Sao Jose Porto Alegre, Rio Grande do Sul | |
| Santiago Clinic Hospital (Hospital Clínico Universitario de Santiago -CHUS) Santiago de Compostela, Galicia | |
| Sapporo Medical University Hospital Sapporo, | |
| Scripps Clinic Torrey Pines La Jolla, California | |
| Semmelweis Egyetem Pulmonologiai Klinika Budapest, | |
| Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do | |
| Seoul National University Hospital Seoul, Seoul Teugbyeolsi | |
| Servicios de Salud IPS Suramericana S.A.S - IPS Sura Industriales Medellín Medellín, ANT | |
| Shamir medical center Be’er Ya‘aqov, M | |
| Shanghai Jiao Tong University - Shanghai Chest Hospital Shanghai, SH | |
| Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai, | |
| Shanghai Pulmonary Hospital Shanghai, | |
| Shenyang Chest Hospital Shenyang, Liaoning | |
| Shenzhen People's Hospital Shenzhen, | |
| Shimane University Hospital Izumo-Shi, | |
| Shri Guru Ram Rai (SGRR) Institute of Medical and Health Sciences - Shri Mahant Indiresh Hospital Dehradun, Uttarakhand | |
| Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital Chengdu, | |
| Sir Run Run Shaw Hospital - Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| SoonChunHyang University Bucheon Hospital Bucheon-si, | |
| SoonChunHyang University Seoul Hospital Yongsan-gu, Seoul | |
| South Texas Veterans Health Care System - Audie L. Murphy VA Hospital San Antonio, Texas | |
| Southeastern Research Center Winston-Salem, North Carolina | |
| St. Antonius Ziekenhuis Nieuwegein, | |
| St. John's Medical College Bangalore, | |
| St. Joseph's Hospital and Medical Center Phoenix, Arizona | |
| St. Vincent's University Hospital Dublin, | |
| Stamford Health Medical Group - Stamford - 29 Hospital Plaza Suite 605 Stamford, Connecticut | |
| Stanford Hospital and Clinics Stanford, California | |
| TC Saglik Bakanlig -Izmir Dr.Suat Seren Gogus Hastaliklari Ve Cerrahisi Egitim Arastirma Hastanesi Izmir, | |
| Taichung Veterans General Hospital Taichung, | |
| Taipei Veterans General Hospital Taipei, | |
| Tallaght University Hospital Dublin, Co Dublin | |
| Tampa General Hospital Tampa, Florida | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| Temple University Hospital (TUH) - Temple Lung Center (TLC) Philadelphia, Pennsylvania | |
| Tenri Hospital Tenri, | |
| The Affiliated Hospital of Inner Mongolia Medical University Hohhot, | |
| The Affiliated Hospital of Xuzhou Medical University Xuzhou, Jiangsu | |
| The Calcutta Medical Research Institute (CMRI) Kolkata, West Bengal | |
| The Catholic University of Korea, Bucheon St. Mary's Hospital Bucheon-si, Gyeonggi-do | |
| The First Affiliated Hospital of Guangzhou Medical University Oncology Department Guangzhou, Guangdong | |
| The First Affiliated Hospital of Nanchang University - Xianghu District Nanchang, JX | |
| The First Affiliated Hospital of Ningbo University Ningbo, | |
| The First Affiliated Hospital of Soochow University Suzhou, | |
| The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan | |
| The First Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong | |
| The First Hospital of China Medical University Shenyang, Liaoning | |
| The First Hospital of Lanzhou University Lanzhou, Gansu | |
| The Jikei University Hospital Tokyo, Minato-ku, | |
| The Ohio State University Wexner Medical Center Columbus, Ohio | |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, | |
| The Second Hospital of Hebei Medical University Shijiazhuang, Hebei | |
| The Second Xiangya Hospital of Central South University Changsha, | |
| The Third Hospital of Hebei Medical University Shijiazhuang, | |
| The University of Alabama at Birmingham Birmingham, Alabama | |
| The University of Chicago Medicine Chicago, Illinois | |
| The University of Vermont Burlington, Vermont | |
| Thomas Jefferson University Hospital - Jane and Leonard Korman Lung Center Philadelphia, Pennsylvania | |
| Thoraxklinik-Heidelberg gGmbH Heidelberg, | |
| Thoraxzentrum Bezirk Unterfranken Münnerstadt, Bavaria | |
| Tianjin Chest Hospital Tianjin, Tianjin Municipality | |
| Tianjin Medical University General Hospital Tianjin, | |
| Toho University - Omori Medical Center Tokyo, | |
| Toho University Ohashi Medical Center Tokyo, | |
| Tokyo Medical University Hospital Shinjuku-Ku, Tokyo | |
| Tokyo Women's Medical University Hospital Tokyo, Shinjuku-ku, | |
| Toranomon Hospital Tokyo, Minato-ku, | |
| Tosei General Hospital Aichi, Seto, | |
| Turun Yliopistollinen Keskussairaala (TYKS) Turku, | |
| UC Irvine Medical Center Orange, California | |
| UZ Leuven Leuven, | |
| Ulsan University Hospital (UUH) Dong-gu, Ulsan | |
| Uludag Universitesi Tip Fakultesi (Uludag University Faculty of Medicine) Bursa, | |
| Unidad de lnvestigacion CIMA S.C. Chihuahua City, | |
| Unidade Local de Saude Braga Braga, | |
| Unidade Local de Saude de Gaia/Espinho, EPE Vila Nova de Gaia, | |
| Unidade Local de Saude de Loures - Odivelas, E. P. E. Loures, | |
| Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente Lisbon, | |
| Unidade Local de Saude de Santo Antonio, E.P.E. Porto, | |
| Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao Porto, | |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei | |
| Unity Hospital Fridley, Minnesota | |
| Universidade Estadual Paulista - Hospital das Clinicas da Faculdade de Medicina de Botucatu (HCFMB) Botucatu, São Paulo | |
| Universitaetsklinikum Essen - Ruhrlandklinik Essen, North Rhine-Westphalia | |
| Universitaetsklinikum Freiburg - Klinik fuer Pneumologie Freiburg I. Breisgau, Baden-Wurttemberg | |
| Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Pneumologie Leipzig, | |
| University General Hospital Attikon Athens, Attica | |
| University General Hospital of Heraklion Heraklion, | |
| University Hospital of Ioannina Ioannina, Epirus | |
| University Hospitals Birmingham NHS Foundation Trust - Heartlands Hospital Birmingham, BIR | |
| University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital Birmingham Birmingham, | |
| University of California UC Davis Medical Center Sacramento, California | |
| University of Cincinnati College of Medicine Cincinnati, Ohio | |
| University of Colorado Anschutz Medical Campus - Department of Family Medicine Aurora, Colorado | |
| University of Florida (UF) Health Shands Hospital Gainesville, Florida | |
| University of Fukui Hospital Yoshida, | |
| University of Maryland - Marlene and Stewart Greenebaum Cancer Center Baltimore, Maryland | |
| University of Michigan Health System - A. Alfred Taubman Health Care Center - Pulmonary Clinic Ann Arbor, Michigan | |
| University of Patras - Rio Regional University Hospital Rio, | |
| University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic Los Angeles, California | |
| University of Thessaly- General University Hospital of Larissa Larissa, | |
| Universitätsklinikum Hamburg-Eppendorf (UKE) Hamburg, | |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz, | |
| Universitätsspital Basel Basel, | |
| Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego Lodz, | |
| Uniwersyteckie Centrum Kliniczne Gdansk, | |
| VCU Medical Center Richmond, Virginia | |
| Vanderbilt Lung Institute - One Hundred Oaks Nashville, Tennessee | |
| Velocity Clinical Research Germany GmbH Ahrensburg, | |
| Velocity Clinical Research Inc. Greenville, South Carolina | |
| Vivantes Klinikum Neukolln Berlin, | |
| Vzw Az Groeninge Kortrijk, | |
| WM Clinica Pneumologica Sociedade Simples LTDA Porto Alegre, Rio Grande do Sul | |
| Warminsko-Mazurskie Centrum Chorób Pluc w Olsztynie Olsztyn, Warmian-Masurian Voivodeship | |
| Washington University School of Medicine in St. Louis St Louis, Missouri | |
| West China Hospital, Sichuan University Chengdu, | |
| Western Washington Medical Group (WWMG) - Everett - Silver Lake Medical Center Location Everett, Washington | |
| Westmead Hospital Westmead, | |
| Wiener Gesundheitsverbund - Klinik Floridsdorf Vienna, | |
| Wonkwang University Hospital Iksansi, | |
| Wuxi People's Hospital Wuxi, | |
| Xi'an International Medical Center Hospital Xi'an, | |
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shi, Shanghai Sheng | |
| Yale New Haven Hospital New Haven, Connecticut | |
| Yichang Central People's Hospital - Xiling Campus Yichang Shi, HE | |
| Yonsei University Health System, Severance Hospital Seoul, | |
| Zhongshan Hospital Fudan University Shanghai, | |
| Zuyderland Medisch Centrum, Sittard-Geleen Heerlen, | |
| hospital Italiano de Buenos Aires Buenos Aires, |
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF) (OMNY-AF)
Study Contact - rshar120@its.jnj.com
NCT06455098
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Diagnosed with symptomatic paroxysmal AF with:
• At least two symptomatic AF episodes within last six months from enrollment
• At least one electrocardiographically documented AF episode within twelve months prior to enrollment * Failed at least one Class I or Class III antiarrhythmic drug * Willing and capable to provide consent * Able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion Criteria:
* Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration)
* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
* Previous surgical or catheter ablation for AF
* Patients known to require ablation outside the PV ostia and outside the CTI region.
* Documented severe dilatation of the left atrium (LAD\>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment
* Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure
* Documented severely compromised left ventricular ejection fraction (LVEF \<40%) by imaging within 6 months prior to enrollment
* Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
* Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months
* Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction \[MI\] within the past 2 months
* Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months
* Valvular cardiac surgical/percutaneous procedure
* Unstable angina within 6 months
* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
* Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Prior diagnosis of pulmonary vein stenosis
* Pre-existing hemi diaphragmatic paralysis
* Acute illness, active systemic infection, or sepsis
* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
* Severe mitral regurgitation
* Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)
* Presence of a condition that precludes vascular access
* Current enrollment in an investigational study evaluating another device or drug
* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
* Life expectancy less than 12 months
* Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU) DEVICE: OMNYPULSE™ Catheter with the TRUPULSE Generator
Atrial Fibrillation
I'm interested
Share via email
Show 46 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Advent Health Orlando Orlando, Florida | |
| Ascension St. Vincent's Jacksonville, Florida | |
| Baptist Health Research Institute Jacksonville, Florida | |
| Beaumont Health Systems Royal Oak, Michigan | |
| Brigham and Women's Hospital Boston, Massachusetts | |
| California Pacific Medical Center- Sutter Health San Francisco, California | |
| Canberra Heart Rhythm Garran, | |
| Cardiovascular Associates of Marin Larkspur, California | |
| Cleveland Clinic Cleveland, Ohio | |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| HCA Florida Mercy Hospital Miami, Florida | |
| Hartford Hospital Hartford, Connecticut | |
| Hoag Memorial Hospital Newport Beach, California | |
| Inova Fairfax Medical Campus- Inova Heart and Vascular Institute Falls Church, Virginia | |
| Intermountain Medical Center Murray, Utah | |
| Johns Hopkins Baltimore, Maryland | |
| Lenox Hill Hospital New York, New York | |
| Loma Linda Medical Center Loma Linda, California | |
| Massachusetts General Boston, Massachusetts | |
| Memorial Health University Medical Center Savannah, Georgia | |
| Mills Peninsula Health Services Burlingame, California | |
| Minneapolis Heart Institute Minneapolis, Minnesota | |
| Montefiore Medical Center The Bronx, New York | |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai School of Medicine New York, New York | |
| NCH Healthcare Naples, Florida | |
| New Mexico Heart Institute Albuquerque, New Mexico | |
| New York Presbyterian - Weill Cornell Medical Ctr New York, New York | |
| NorthShore University Medical Center Glenview, Illinois | |
| Northside Hospital Atlanta, Georgia | |
| Phoenix Cardiovascular Research Group Phoenix, Arizona | |
| Piedmont Healthcare Atlanta, Georgia | |
| Providence Saint John s Health Center Santa Monica, California | |
| Royal Adelaide Hospital Adelaide, South Australia | |
| Royal Melbourne Hospital Parkville, Victoria | |
| San Diego Cardiac Center San Diego, California | |
| Scripps Clinic/Prebys Cardiovascular Institute La Jolla, California | |
| Sentara Norfolk General Hospital Norfolk, Virginia | |
| St Francis Hospital Roslyn, New York | |
| Texas Cardiac Arrhythmia Research Foundation Austin, Texas | |
| Texas Heart Institute Houston, Texas | |
| University of Colorado Aurora, Colorado | |
| University of Pennsylvania Health System Philadelphia, Pennsylvania | |
| Virginia Commonwealth University Richmond, Virginia | |
| WakeMed Heart & Vascular Raleigh, North Carolina | |
| York Hospital York Village, Maine |
Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer
ctrrecruit@vcu.edu
NCT06568172
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Pathologically (histologically or cytologically) proven diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC
* The following CSCC subtypes are eligible according to World Health Organization (WHO) classification if the predominant histology is confirmed CSCC.
* Spindle cell squamous cell carcinoma (SCC)
* Squamous cell carcinoma with sarcomatoid differentiation
* Acantholytic SCC
* Clear cell SCC
* Lymphoepithelial carcinoma
* Note: Keratoacanthoma SCC and Verrucous SCC subtypes are not eligible.
* For patients with regional metastasis without a primary tumor at screening: a clinical history of CSCC that drains to the involved regional lymph nodes or in-transit metastases in question is required
* For example, a parotid mass shown to be SCC by cytologic analysis of a fine needle aspirate in a patient with a clinical history of CSCC on the ipsilateral scalp would be eligible
* For patients with regional metastases without a primary tumor and an ambiguous clinical history: tumor genomic sequencing suggesting a primary tumor of cutaneous origin would be acceptable evidence to establish eligibility
* NOTE: Tumor genomic sequencing is not required to determine eligibility, but may be part of the routine evaluation of patients with cancers of unknown primary at some institutions. For example, a parotid mass shown to be SCC by cytologic analysis of fine needle aspirate without a primary tumor and an ambiguous clinical history, but with a tumor genomic sequencing assay demonstrating a high tumor mutation burden (≥ 10 mutations/Mb) and/or a high fraction of ultraviolet (UV) related mutations (\> 50% of mutations \[cytosine (C)/thymine (T)\]C \> T or CC \> TT) and/or the presence of "signature 7" mutations would be eligible (Chang 2021)
* Previously untreated or recurrent CSCC
* Clinical American Joint Committee on Cancer (AJCC) 8th Edition (eyelid, head and neck sites) or Union for International Cancer Control (UICC) (non-head and neck sites) stage III or IV
* Primary tumor site must be in the head and neck cutaneous region, other non-head and neck cutaneous regions, or eyelid cutaneous region
* No mucosal squamous cell carcinoma (vermillion lip, nasal, oral, sinonasal, conjunctival, anogenital)
* Tumor must be resectable with curative intent. Note: Tumor with bony skull base invasion and/or skull base foramen involvement (T4b) is not eligible. (Patients with T4b eyelid tumors using UICC Staging, and not involving the brain, are eligible.)
* At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* No definitive clinical or radiologic evidence of distant metastatic disease (M1), visceral and/or distant nodal disease
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Not pregnant and not nursing
* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
* Absolute neutrophil count (ANC) ≥ 1,000 cells/mm\^3
* Platelets ≥ 75,000 cells/mm\^3
* Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8.0 g/dl is acceptable)
* Creatinine clearance (CrCL) \> 30mL/min by the Cockcroft-Gault formula
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (NOTE: For patients with Gilbert's syndrome, total bilirubin ≤ 3 x ULN. Gilbert's syndrome must be documented appropriately as past medical history.)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 x institutional ULN
* No prior systemic therapy for the study cancer (including patients currently receiving immunotherapy for a separate malignancy)
* No prior radiotherapy to the region of the study cancer that would result in cumulative doses of radiation to organs at risk for radiation injury that exceed protocol limitations
* No history of myocardial infarction/unstable angina within the last 6 months
* New York Heart Association functional classification IIb or better (New York Heart Association \[NYHA\] functional classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification)
* No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
* No history of allogeneic stem cell transplantation, or autologous stem cell transplantation
* No history of a solid organ transplant (other than corneal transplant)
* No active, known, or suspected autoimmune disease
* Active or known disease is defined as:
* Requiring higher than physiologic steroid levels (\> 10mg prednisone/day or equivalent) or
* Requiring disease-modifying agents or
* Ongoing or recent (within 5 years prior to registration) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs)
* NOTES:
* Patients meeting the following criteria are not considered immunosuppressed and are eligible to enroll:
* Patients who require a brief course of steroids (eg, prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded
* Patients with type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
* Physiologic replacement doses ≤ 10 mg prednisone/day or equivalent allowed, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted
* Patients with the following immunosuppressed conditions are eligible to enroll:
* Patients with HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible
* Patients with chronic lymphocytic leukemia (CLL) with no history of anti-CLL therapy within 6 months prior to registration are eligible
* No history of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia)
* No active, noninfectious pneumonitis requiring immune-suppressive therapy
* No active tuberculosis
* No live vaccines within 28 days prior to registration
* No history of allergic reaction to the study agent, compounds of similar chemical or biologic composition to the study agent (or any of its excipients) PROCEDURE: Biospecimen Collection, BIOLOGICAL: Cemiplimab, PROCEDURE: Computed Tomography, RADIATION: Image Guided Radiation Therapy, RADIATION: Intensity-Modulated Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, OTHER: Questionnaire Administration, PROCEDURE: Surgical Procedure, PROCEDURE: Surgical Procedure
Eyelid Squamous Cell Carcinoma, Recurrent Eyelid Squamous Cell Carcinoma, Recurrent Skin Acantholytic Squamous Cell Carcinoma, Recurrent Skin Clear Cell Squamous Cell Carcinoma, Recurrent Skin Lymphoepithelial Carcinoma, Recurrent Skin Spindle Cell Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma With Sarcomatoid Differentiation, Resectable Eyelid Squamous Cell Carcinoma, Resectable Skin Acantholytic Squamous Cell Carcinoma, Resectable Skin Clear Cell Squamous Cell Carcinoma, Resectable Skin Lymphoepithelial Carcinoma, Resectable Skin Spindle Cell Squamous Cell Carcinoma, Resectable Skin Squamous Cell Carcinoma With Sarcomatoid Differentiation, Skin Acantholytic Squamous Cell Carcinoma, Skin Clear Cell Squamous Cell Carcinoma, Skin Lymphoepithelial Carcinoma, Skin Spindle Cell Squamous Cell Carcinoma, Skin Squamous Cell Carcinoma With Sarcomatoid Differentiation, Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
I'm interested
Share via email
Show 200 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Allegheny General Hospital Natrona Heights, Pennsylvania | |
| Alton Memorial Hospital Alton, Illinois | |
| Atrium Health Cabarrus/LCI-Concord Concord, North Carolina | |
| Atrium Health Cleveland/LCI-Cleveland Shelby, North Carolina | |
| Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina | |
| Atrium Health Stanly/LCI-Albemarle Albemarle, North Carolina | |
| Atrium Health Union/LCI-Union Monroe, North Carolina | |
| Atrium Health University City/LCI-University Charlotte, North Carolina | |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| BCCA-Vancouver Cancer Centre Vancouver, British Columbia | |
| Banner MD Anderson Cancer Center Gilbert, Arizona | |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Chris O'Brien Lifehouse Camperdown, New South Wales | Site Public Contact - (researchgovernance@lh.org.au) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| City of Hope Antelope Valley Lancaster, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope South Pasadena South Pasadena, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Upland Upland, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope at Irvine Lennar Irvine, California | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Dartmouth Cancer Center - North Saint Johnsbury, Vermont | Site Public Contact - (cancer.research.nurse@hitchcock.org) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Duke Cancer Center Raleigh Raleigh, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke University Medical Center Durham, North Carolina | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| First Physicians Group - Silverstein Institute at Floyd Street Sarasota, Florida | Site Public Contact - (researchinstitute@smh.com) |
| Florida Cancer Specialists - Sarasota Sarasota, Florida | Site Public Contact - (Roster@nrgoncology.org) |
| Florida Cancer Specialists - Sarasota Downtown Sarasota, Florida | |
| Florida Cancer Specialists - Venice Island Venice, Florida | Site Public Contact - (Roster@nrgoncology.org) |
| Florida Cancer Specialists - Venice Pinebrook Venice, Florida | Site Public Contact - (ClinicalTrials@FLCancer.com) |
| Forbes Hospital Monroeville, Pennsylvania | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Franciscan Health Indianapolis Indianapolis, Indiana | |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Goshen Center for Cancer Care Goshen, Indiana | Site Public Contact - (cccois@goshenhealth.com) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Heartland Oncology and Hematology LLP Council Bluffs, Iowa | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| IU Health North Hospital Carmel, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Inova Schar Cancer Institute Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Lenox Hill Hospital New York, New York | |
| Levine Cancer Institute-Gaston Gastonia, North Carolina | |
| Levine Cancer Institute-Rock Hill Rock Hill, South Carolina | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson League City League City, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson West Houston Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in Sugar Land Sugar Land, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in The Woodlands Conroe, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri | |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Methodist Jennie Edmundson Hospital Council Bluffs, Iowa | |
| MetroHealth Medical Center Cleveland, Ohio | Site Public Contact - (ababal@metrohealth.org) |
| Miami Cancer Institute Miami, Florida | |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital North Englewood, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha, Nebraska | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| Nebraska Methodist Hospital Omaha, Nebraska | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Peter MacCallum Cancer Centre Melbourne, | |
| Princess Alexandra Hospital Woolloongabba, | Site Public Contact - (Roster@nrgoncology.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Rock Hill Radiation Therapy Center Rock Hill, South Carolina | |
| Rush MD Anderson Cancer Center Chicago, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| SUNY Upstate Medical Center-Community Campus Syracuse, New York | |
| Saint Vincent Hospital Erie, Pennsylvania | |
| Saint Vincent's Hospital Fitzroy, Victoria | Site Public Contact - (Roster@nrgoncology.org) |
| Sarasota Memorial Health Care Center at University Parkway Sarasota, Florida | |
| Sarasota Memorial Hospital Sarasota, Florida | |
| Sarasota Memorial Hospital-Venice N. Venice, Florida | |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| The Angeles Clinic and Research Institute - West Los Angeles Office Los Angeles, California | Site Public Contact - (ctsucontact@westat.com) |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Torrance Memorial Physician Network - Cancer Care Torrance, California | Site Public Contact - (courtney.steeneken@tmphysicians.com) |
| Tower Cancer Research Foundation Beverly Hills, California | Site Public Contact - (towercancerresearch@toweroncology.com) |
| Townsville General Hospital Townsville, Queensland | Site Public Contact - (Roster@nrgoncology.org) |
| UC San Diego Health System - Encinitas Encinitas, California | |
| UC San Diego Medical Center - Hillcrest San Diego, California | Site Public Contact - (rhabbaba@health.ucsd.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UH Seidman Cancer Center at UH Avon Health Center Avon, Ohio | |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Doral Doral, Florida | Site Public Contact - (kginnity@med.miami.edu) |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown, Pennsylvania | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern Simmons Cancer Center - RedBird Dallas, Texas | Site Public Contact - (canceranswerline@utsouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | Site Public Contact - (cancer@uchealth.com) |
| University of Illinois Chicago, Illinois | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan - Brighton Center for Specialty Care Brighton, Michigan | |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont Medical Center Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Penn Hospital Pittsburgh, Pennsylvania | |
| Wexford Health and Wellness Pavilion Wexford, Pennsylvania | Site Public Contact - (Dawnmarie.DeFazio@ahn.org) |
| William S Middleton VA Medical Center Madison, Wisconsin | |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Wollongong Hospital Wollongong, New South Wales | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
Clinical Team - clinicaltrials@deciphera.com
NCT06619561
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression. a. May have persistent active acute GVHD (aGVHD) and chronic GVHD (cGVHD) manifestations (overlap syndrome).
• Participants with active cGVHD who have received and failed at least 2 prior lines of systemic therapy.
• Stable dose of systemic corticosteroids is permitted but not required. If being taken, participants should be on a stable dose of corticosteroids for at least 2 weeks prior to starting study drug treatment.
• Adequate organ and bone marrow functions.
• Participants of reproductive potential agree to follow the contraception requirements.
• Karnofsky Performance Scale (KPS) of ≥60.
Exclusion Criteria:
• Has aGVHD without manifestations of cGVHD.
• Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD.
• History or other evidence of severe illness, uncontrolled infection, or any other conditions that would make the participant unsuitable for the study. All wounds must be healed and free of infection or dehiscence.
• History of malignancy except for:
• Underlying malignancy for which the transplant was performed
• Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to enrollment and felt to be at low risk for recurrence.
• Malabsorption syndrome or other illness that could affect oral absorption.
DRUG: Vimseltinib
Chronic Graft-Versus-Host Disease (cGVHD)
Allogeneic hematopoietic stem cell transplant (HSCT), Graft-Versus-Host Disease, GVHD, cGVHD, Graft versus host disease, Immune System Diseases, Organizing Pneumonia, Bronchiolitis Obliterans, Bronchiolitis, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Bronchiolitis Obliterans Syndrome, Graft vs Host Disease, Sclerosis, Fibrosis, Hematopoietic stem cell transplantation, Liver diseases
I'm interested
Share via email
Show 26 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| AdventHealth Orlando Apopka, Florida | |
| Avera Cancer Institute Sioux Falls, South Dakota | |
| City of Hope National Medical Center Duarte, California | |
| Cleveland Clinic Cleveland, Ohio | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Duke University Hospital Durham, North Carolina | |
| Emory University winship Cancer Institute Atlanta, Georgia | |
| Henry Ford Cancer Institute Detroit, Michigan | |
| Intermountain Health Murray, Utah | |
| Levine Cancer Institute Charlotte, North Carolina | |
| Moffitt Cancer Center Tampa, Florida | |
| Oncology Hematology Care Clinical Trials, LLC Cincinnati, Ohio | |
| Oregon Health and Science University Portland, Oregon | |
| Ronald Regan UCLA Medical Center Los Angeles, California | |
| St. David's South Austin Medical Center Austin, Texas | |
| The Ohio State University Comprehensive Cancer Center Columbus, Ohio | |
| Tristar Bone Marrow Transplant Nashville, Tennessee | |
| UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | |
| UT Southwestern Medical Center Dallas, Texas | |
| University of California Irvine Health Orange, California | |
| University of Illinois Medical Center - Hematology & Oncology Chicago, Illinois | |
| University of Kansas Cancer Center-Westwood Westwood, Kansas | |
| University of Kentucky Markey Cancer Center Lexington, Kentucky | |
| Vanderbilt-Ingram Cancer Center Nashville, Tennessee | |
| Virginia Commonwealth University Richmond, Virginia | |
| Washington University School of Medicine - Siteman Cancer Center St Louis, Missouri |
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) (TRANSCEND)
US Biogen Clinical Trial Center - clinicaltrials@biogen.com
NCT06685757
Show full eligibility criteria
Hide eligibility criteria
Key
• Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or PLEX.
• Complement system inhibitors (e.g., eculizumab).
• Proteasome inhibitors (e.g., bortezomib).
• Tocilizumab.
• Any B cell-depleting therapy (including anti-Cluster of Differentiation 20 \[CD20\] agents \[e.g., rituximab\]) within 3 months prior to randomization.
• Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization. Note: Other protocol-defined inclusion/exclusion criteria apply.
Inclusion Criteria:
* Active or chronic active AMR (biopsy-confirmed) without TCMR per central reading, as defined by the Banff 2022 criteria.
* Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors).
* Donor-specific antibody (DSA): Human leukocyte antigen (HLA) Class I and/or II antigen-specific DSA-positive (preformed and/or de novo DSA) as determined by the local laboratory's definition of positivity using singleantigen bead-based assays within 3 months prior to randomization.
Key Exclusion Criteria:
* Transplant: Blood type (ABO)-incompatible transplant.
* History of multiple organ transplants including en bloc and dual kidney transplants.
* Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the subsequent 30 days as determined by the Investigator.
* Treatment: Prior AMR/TCMR treatment (with the exception of corticosteroids) within 3 months prior to randomization is excluded as listed below. Participants who received any of these treatments between 3 and 6 months prior to randomization must have both a renal biopsy (IC3) and DSA testing at least 6 weeks after completing (or stopping) treatment in order to confirm continuing AMR and to determine eligibility:
• Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or PLEX.
• Complement system inhibitors (e.g., eculizumab).
• Proteasome inhibitors (e.g., bortezomib).
• Tocilizumab.
• Any B cell-depleting therapy (including anti-Cluster of Differentiation 20 \[CD20\] agents \[e.g., rituximab\]) within 3 months prior to randomization.
• Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization. Note: Other protocol-defined inclusion/exclusion criteria apply.
DRUG: Felzartamab, DRUG: Placebo
Antibody-mediated Rejection
AMR, Felzartamab, Kidney Transplant
I'm interested
Share via email
Show 59 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Auckland City Hospital Auckland, | |
| CHU Grenoble Alpes Hôpital Michallon La Tronche, | |
| CHU Lyon Hôpital Edouard Herriot Bordeaux, | |
| California Pacific Medical Center San Francisco, California | |
| Cedars-Sinai Medical Center Beverly Hills, California | |
| Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil Toulouse, | |
| Charite University Berlin, | |
| Cleveland Clinic Cleveland, Ohio | |
| Clínica Privada Velez Sarsfield Córdoba, | |
| Cooperman Barnabas Medical Center West Orange, New Jersey | |
| Duke University Durham, North Carolina | |
| Fiona Stanley Hospital Murdoch, | |
| Fundação Oswaldo Ramos - Hospital do Rim (HRIM) Vila Clementino, São Paulo | |
| Hospices Civils de Lyon - Hôpital Édouard Herriot Lyon, | |
| Hospital Clinic de Barcelona Barcelona, | |
| Hospital Del Mar Barcelona, | |
| Hospital Universitario Miguel Servet Zaragoza, | |
| Hospital Universitario Vall d'Hebron Barcelona, | |
| Hospital Universitario de Bellvitge Barcelona, Spain | |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo São Paulo, | |
| Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto Vila São José, São José Do Rio Preto | |
| Houston Methodist Houston, Texas | |
| Institute for Clinical and Experimental Medicine (IKEM) Prague, | |
| Instituto de Trasplante y Alta Complejidad (ITAC) Cdad, Autónoma de Buenos Aires | |
| Loma Linda San Bernardino, California | |
| Mayo Clinic Rochester, Minnesota | |
| McGill University Montreal, Quebec | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of Vienna Spitalgasse, Vienna | |
| Penn Medicine - Hospital of the University of Pennsylvania Philadelphia, Pennsylvania | |
| Princess Alexandra Hospital Woolloongabba, | |
| Providence Healthcare Orange, California | |
| Royal Melbourne Hospital Parkville, Victoria | |
| Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer Centro Histórico, Porto Alegre - RS | |
| The Ohio State University Columbus, Ohio | |
| The University of British Columbia (UBC)/St. Paul's Hospital part of Providence Health Care Vancouver, British Columbia | |
| Tulane University Health Sciences Center New Orleans, Louisiana | |
| UCLA Santa Monica, California | |
| UT Southwestern Medical Center Dallas, Texas | |
| Universitaetsklinikum Carl Gustav Carus Dresden Dresden, | |
| Universitatsklinikum Hamburg-Eppendorf Hamburg, | |
| Universitatsklinikum Regensburg Regensburg, | |
| Universitatsspital Zurich Zurich, | |
| University Hospital Basel Petersgraben, Basel | |
| University of Alberta Edmonton, | |
| University of California, San Francisco San Francisco, California | |
| University of Chicago Chicago, Illinois | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Colorado Aurora, Colorado | |
| University of Kansas Kansas City, Kansas | |
| University of Michigan Ann Arbor, Michigan | |
| University of Nebraska Omaha, Nebraska | |
| University of Southern California Los Angeles, California | |
| University of Washington Medical Center Seattle, Washington | |
| Vancouver General Hospital Vancouver, British Columbia | |
| Vanderbilt University Nashville, Tennessee | |
| Virginia Commonwealth University Richmond, Virginia | |
| Washington University St Louis, Missouri | |
| Westmead Hospital Westmead, |
Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+
Massey IIT Research Operations - masseyepd@vcu.edu
NCT06846463
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Patients must have a documented pathologic diagnosis of DLBCL at any stage.
* Must have documented MYD88 L265P, CD79B, or NOTCH1 truncation mutation or be CD5+ by IHC.
* Age ≥18 years on the day of signing the informed consent form.
* Patients must have measurable disease on Positron Emission Tomography-Computed Tomography scan (CT/PET) imaging.
* Patient must have received no more than one cycle of R-CHOP prior to enrollment. Length of time between first R-CHOP treatment and planned 2nd R-CHOP treatment should vary by no more than 21 days ± 3 days.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
* Adequate bone marrow function as defined by:
* Absolute neutrophil count (ANC) ≥1000/mm3, except for patients with bone marrow involvement in which ANC must be ≥500/mm3.
* Platelet ≥75,000/mm3, except for patients with bone marrow involvement in which the platelet count must be ≥30,000/mm3.
* Hemoglobin ≥7 g/dL, after transfusion if necessary
* Adequate organ function defined as:
* Creatinine clearance ≥30 mL/min as estimated by the Cockcroft-Gault equation.
* Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase, and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase ≤2.5 × upper limit of normal (ULN).
* Serum total bilirubin ≤3 x ULN (except patients with Gilberts syndrome 3g/dl).
* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
* Women of childbearing potential and men must agree to use one of the following highly effective forms of birth control during the treatment and for 1 month following completion of study treatment for women and for 1 week following completion of study treatment for men.
* combined (estrogen and progestogen containing) hormonal contraception:
* oral
* intravaginal
* transdermal
* progestogen-only hormonal contraception associated with inhibition of ovulation
* oral
* injectable
* implantable
* intrauterine device (IUD)
* intrauterine hormone-releasing system (IUS)
* bilateral tubal occlusion
* vasectomized partner
* heterosexual abstinence
* Patients must not have any known allergies, hypersensitivity or intolerance to corticosteroids or monoclonal antibodies.
* Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments.
Exclusion Criteria:
* Patients with high grade B-cell lymphoma with myelocytomatosis oncogene /immunoglobulin heavy-chain (MYC)/IGH and BCL-2 rearrangements.
* Patients with brain metastasis.
* Patients with peripheral neuropathy CTCAE grade ≥2.
* Any uncontrolled or clinically significant cardiovascular disease including the following:
* Myocardial infarction within 6 months before screening.
* Unstable angina within 3 months before screening.
* New York Heart Association class III or IV congestive heart failure.
* History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes).
* Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer.
* History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
* Severe or debilitating pulmonary disease in the opinion of the treating investigator.
* Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
* Active fungal, bacterial and/or viral infection requiring systemic therapy.
* Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs.
* Active infection with HIV, or serologic status reflecting active hepatitis B or C infection as follows:
* Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (\< 20 IU), and if they are willing to undergo monitoring every 4 weeks for HBV reactivation.
* Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable.
* Major surgery within 4 weeks of the first dose of study drug.
* Pregnant or lactating women.
* Left ventricular ejection fraction (LVEF) \<55% on screening echocardiogram.
* Vaccination or requirement for vaccination with a live vaccine within 28 days prior to the first dose of study drug or at any time during planned study treatment.
* Hypersensitivity to zanubrutinib, rituximab, cyclophosphamide, doxorubicin, vincristine, or prednisone.
* Requires ongoing treatment with a strong CYP3A inducer (Table 3).
* Concurrent participation in another therapeutic clinical trial.
* Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).
* Requires ongoing treatment with warfarin or warfarin derivatives. DRUG: Zanubrutinib
Diffuse Large B-Cell Lymphoma, DLBCL - Diffuse Large B Cell Lymphoma
I'm interested
Share via email
Show 1 location
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Massey Heme Malig Team - (MasseyHemMlg@vcu.edu) |