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642 Study Matches
Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors
ctrrecruit@vcu.edu
NCT06002828
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Inclusion Criteria:
* Patient must be \>= 18 years of age at the time of registration
* Patient must have been between the ages of 15-39 at the time of their first primary cancer diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma (NHL)
* Patient must have completed therapy (with a complete response, per clinician determination) at the time of registration
* Patients last date of prior systemic therapy for first primary diagnosis for Hodgkin lymphoma or non-Hodgkin lymphoma must have been within one year prior to registration
* NOTE: Systemic therapy refers to all anti-cancer therapy, including but not limited to chemotherapy, intravenous (IV) or oral targeted medications, or radiation, and administered via a clinical trial or standard approach
* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3
* Patient must be English speaking in order to be able to complete the required QOL forms on this study
* NOTE: Sites cannot translate the associated QOL forms
* Patient must not be receiving active therapy for Hodgkin lymphoma or non-Hodgkin lymphoma
* Patient must have internet access through computer, tablet, or smartphone
* Patient must have email address
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible PROCEDURE: Biospecimen Collection, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Hodgkin Lymphoma, Non-Hodgkin Lymphoma
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| 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) |
| Advanced Breast Care Center PLLC Warren, Michigan | |
| 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) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Anchorage Oncology Centre Anchorage, Alaska | |
| Anchorage Radiation Therapy Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Ann M Wierman MD LTD Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Ascension Borgess Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Ascension Via Christi - Pittsburg Pittsburg, Kansas | Site Public Contact - (jennifer.jameson@ascension.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) |
| BASS Medical Group - Lennon Walnut Creek, California | Site Public Contact - (brenna.lindsey@bassmedicalgroup.com) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| 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) |
| Bay Area Breast Surgeons Inc Emeryville, California | |
| Bay Area Hospital Coos Bay, Oregon | Site Public Contact - (cherie.cox@bayareahospital.org) |
| Bay Area Tumor Institute Oakland, California | |
| Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan | |
| Borgess Medical Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Boulder Community Foothills Hospital Boulder, Colorado | Site Public Contact - (info@westernstatesncorp.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) |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| Cambridge Medical Center Cambridge, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| 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 Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer and Blood Specialists-Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.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) |
| Caro Cancer Center Caro, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| 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) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Cheyenne Regional Medical Center-West Cheyenne, Wyoming | |
| Chilton Medical Center Pompton, New Jersey | |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Contra Costa Regional Medical Center Martinez, California | |
| Corewell Health Grand Rapids Hospitals - Butterworth 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 | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delbert Day Cancer Institute at PCRMC Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Epic Care Cyberknife Center Walnut Creek, California | |
| Epic Care Partners in Cancer Care Emeryville, California | |
| Epic Care-Dublin Dublin, California | |
| 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 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) |
| Fairbanks Memorial Hospital Fairbanks, Alaska | Site Public Contact - (Veronica.Stevenson@foundationhealth.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) |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Freeman Physician Group of Pittsburg Pittsburg, Kansas | Site Public Contact - (BNMathew@freemanhealth.com) |
| 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) |
| Genesee Cancer and Blood Disease Treatment Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesee Hematology Oncology PC Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| GenesisCare USA - Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Las Vegas Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Vegas Tenaya Las Vegas, Nevada | Site Public Contact - (research@sncrf.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) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Good Samaritan Regional Health Center Mount Vernon, Illinois | |
| Great Lakes Cancer Management Specialists-Doctors Park East China, Michigan | |
| Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb, Michigan | |
| Great Lakes Cancer Management Specialists-Macomb Professional Building Warren, Michigan | |
| Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods, Michigan | |
| Greater Regional Medical Center Creston, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.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) |
| HaysMed Hays, Kansas | |
| Health Partners Inc Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (linda.schumacher@mymlc.com) |
| 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 - (karen.forman@ascension.org) |
| Henry Ford Madison Heights Hospital - Breast Warren, Michigan | |
| Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan | |
| Holy Cross Hospital Silver Spring, Maryland | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Center Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.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) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Healthcare Port Townsend, Washington | |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Katmai Oncology Group Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Las Vegas Prostate Cancer Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Cathedral Rock Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pebble Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pecos Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Smoke Ranch Las Vegas, Nevada | Site Public Contact - (research@smcrf.org) |
| Las Vegas Urology - Sunset Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| 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) |
| MGC Hematology Oncology-Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| Macomb Hematology Oncology PC Warren, Michigan | |
| Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Minocqua Center Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Wausau Center Wausau, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Ladysmith Ladysmith, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Neillsville Neillsville, 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) |
| Mary Greeley Medical Center Ames, Iowa | |
| 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 | |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Medical Center Modesto, California | Site Public Contact - (pallante.beth@mhsil.com) |
| Mercy Cancer Center-West Lakes Clive, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Health - Paducah Cancer Center Paducah, Kentucky | Site Public Contact - (BJWarner@mercy.com) |
| 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 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 Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| 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) |
| 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 Cancer and Blood - Ankeny Ankeny, Iowa | |
| Mission Cancer and Blood - Des Moines Des Moines, Iowa | |
| Mission Cancer and Blood - Laurel Des Moines, Iowa | |
| Mission Cancer and Blood - West Des Moines Clive, Iowa | |
| Mississippi Baptist Medical Center Jackson, Mississippi | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| 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) |
| 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) |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Morristown Medical Center Morristown, New Jersey | |
| Mountain Blue Cancer Care Center - Swedish Englewood, Colorado | |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.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) |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas | Site Public Contact - (Emily.Carvell@bmhcc.org) |
| 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) |
| Newton Medical Center Newton, New Jersey | |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (ewd_research_admin@hshs.org) |
| Olathe Health Cancer Center Olathe, Kansas | Site Public Contact - (atheCCResearch@kumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
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| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Cancer Institute Clackamas Clinic Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Medical Foundation - Santa Rosa Santa Rosa, California | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
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| 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) |
| Radiation Oncology Associates Reno, Nevada | Site Public Contact - (research@sncrf.org) |
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| Riverwood Healthcare Center Aitkin, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Rocky Mountain Cancer Centers - Centennial Centennial, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers - Swedish Englewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
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| Rose Medical Center Denver, Colorado | |
| Rush - Copley Medical Center Aurora, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
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| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Anthony's Health Alton, Illinois | |
| 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 - (melissa_beckman@bshsi.org) |
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| Saint Louis Cancer and Breast Institute-Ballwin Ballwin, Missouri | |
| Saint Louis Cancer and Breast Institute-South City St Louis, Missouri | |
| 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) |
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| Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Saint Mary's Regional Medical Center Reno, Nevada | |
| 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 - (ewd_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| 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) |
| Skagit Regional Health Cancer Care Center Mount Vernon, Washington | Site Public Contact - (rcccclinicalresearch@skagitvalleyhospital.org) |
| Southeast Cancer Center Cape Girardeau, Missouri | |
| 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 | |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
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| 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 Englewood, Colorado | |
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| Swedish Medical Center-Cherry Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
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| The Melanoma and Skin Cancer Institute Englewood, Colorado | Site Public Contact - (ryan.weight@theskincancerinstitute.com) |
| The Women's Imaging Center Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| ThedaCare Cancer Care - Berlin Berlin, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - New London New London, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Shawano Shawano, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Waupaca Waupaca, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Medical Center - Neenah Neenah, Wisconsin | Site Public Contact - (ResearchDept@thedacare.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) |
| Trinity Regional Medical Center Fort Dodge, Iowa | |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Unity Hospital Fridley, Minnesota | |
| University Cancer Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| 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 at North Kansas City Hospital 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 Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
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| University of Nevada at Reno Veterans Affairs Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
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| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| Urology Specialists of Nevada - Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
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| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Valley Radiation Oncology Peru, Illinois | |
| 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) |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Western Illinois Cancer Treatment Center Galesburg, Illinois |
ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients
Jeff Lam, MS - jeff.lam@mountsinai.org
NCT05988411
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Inclusion Criteria:
* Age ≥ 18;
* Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as successful pulmonary vein isolation, if needed, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation, must have been completed). Note: the clinical recurrences must primarily be atrial fibrillation, and not atrial flutter/tachycardia (that is, a prospective patient may have a AFL/AT recurrences, but AF must be the dominant recurrent rhythm.)
* History of hypertension and either:
* Documented history of SBP≥160 or DBP≥100, or;
* Receiving ≥1 antihypertensive medication;
* Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
Exclusion Criteria:
* Long-standing persistent AF (\>12 months); \>3 prior atrial fibrillation ablations (lifetime); AF ablation within 3 months of enrollment; extensive scar in left atrium.
* Individual with valvular AF or AF due to a reversible cause
* Prior treatment with other devices for hypertension including but not limited to ROX Coupler, Mobius stent, and/or the CVRx barostimulator device.
* NYHA class IV congestive heart failure;
* Individual has renal artery anatomy that is ineligible for treatment (as determined by renal angiography);
* Main renal artery diameter \<3mm or \>8.0 mm
* Main renal treatable artery length \< 20 mm (length may include proximal branches)
* Presence of renal artery stenosis of any origin ≥30%
* Calcification in renal arteries
* Prior renal denervation procedure
* Presence of abnormal kidney tumors
* Renal artery aneurysm
* Pre-existing renal stent or history of renal artery angioplasty
* Pre-existing aortic stent or history of aortic aneurysm
* Fibromuscular disease of the renal arteries
* Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
* Individual has an estimated glomerular filtration rate (eGFR) of less than 40mL/min/1.73m2, using the MDRD calculation;
* Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
* Individual with known allergy to contrast medium not amendable to treatment.
* Life expectancy \<1 year for any medical condition
* Individual has experienced a myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit.
* Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis.
* Female participants who are pregnant or nursing.
* Individual has known secondary hypertension.
* Individual has a single functioning kidney (either congenitally or iatrogenically).
* Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
* Patients concurrently enrolled in any other investigational drug or device trial that would interfere with the conduction of this protocol. DEVICE: Renal Denervation, DEVICE: Catheter Ablation
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
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Study Locations
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| Location | Contacts |
|---|---|
| Arrhythmia Research Group Jonesboro, Arkansas | Sarah Owens - (sowens@dnairresearch.com) |
| Christus Tyler, Texas | Adrian Maples - (adrian.maples@christushealth.org) |
| Henry Ford Health System Detroit, Michigan | Danielle Delmotte - (ddelmot2@hfhs.org) |
| Los Robles Medical Center Thousand Oaks, California | Marya Bengali - (Marya.Bengali@HCAhealthcare.com) |
| Mount Sinai Hospital New York, New York | Jeff Lam, MS - (jeff.lam@mountsinai.org) Betsy Ellsworth, MSN ANP - (betsy.ellsworth@mountsinai.org) |
| Trident Medical Center Charleston, South Carolina | Molly Harper - (Molly.Harper@hcahealthcare.com) |
| UCSF San Francisco, California | Marialena Varympopioti - (MariaEleni.Varympopioti@ucsf.edu) |
| Virginia Commonwealth University Richmond, Virginia | Caleb Bridgwater - (Caleb.Bridgwater@vcuhealth.org) |
Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial
ctrrecruit@vcu.edu
NCT05710328
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Inclusion Criteria:
* Patients (all genders) must be \>= 18 years of age.
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Patient must have histologically confirmed HER2-positive primary invasive breast carcinoma by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines that has been determined by local testing.
* Patient must have known (either positive or negative) hormone receptor (estrogen receptor \[ER\] or progesterone receptor \[PR\]) status by local testing, per ASCO/CAP guidelines. Patients with either hormone receptor-positive or hormone receptor- negative HER2-positive breast cancer are eligible.
* Patient must have American Joint Committee on Cancer (AJCC) 8th Edition stage IIa-IIIc according to anatomic staging table at diagnosis and below criteria.
* Patients without nodal involvement (cN0) are eligible if T size \> 2.0 cm (T2-4)
* Patients with nodal involvement (cN1-3) are eligible if T2-4
* Patients with clinical T4d are not eligible
* Patients with bilateral invasive breast cancers are eligible if both cancers are HER2-positive and at least one meets all protocol eligibility criteria and neither cancer renders the patient ineligible.
* Patients with multiple ipsilateral invasive tumors are eligible as long as all tumors are HER2-positive and at least one tumor focus meets all eligibility criteria. Multiple lesions that appear part of the same index tumor do not require additional biopsy/HER2 testing.
* Patient must plan to start a standard neoadjuvant pertuzumab (or other biosimilars) based regimen.
* 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 this imaging intervention are eligible for this trial.
* Patients with human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
* Patient must be participating in the trial at an institution which has agreed to perform the imaging research studies, completed the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Center Group (ECOG-ACRIN) defined PET/CT scanner qualification procedures and received ECOG-ACRIN PET/CT scanner approval.
* For patients who completed the baseline (T0) FDG-PET/CT PRIOR to registration, neoadjuvant pertuzumab-based regimen must start after study registration and within 21 days after the T0 scan.
* Patients must not have used colony stimulating growth factors within 14 days prior to completing a T0 scan done prior to registration.
Exclusion Criteria:
* Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the teratogenic effects of FDG in addition to the radiation exposure during PET/CT. All patients of childbearing potential must have a blood test or urine study within 7 days prior to registration to rule out pregnancy.
* NOTE: A pregnancy test within 7 days prior to the T0 scan is also required but will only need to be done if a) the T0 scan is completed after study registration and b) if the pregnancy test done prior to registration is completed outside of the 7-day window.
A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
* Patient must not have any contraindication to FDG-PET/CT imaging which includes routine glucose values \> 200 mg/dL and severe claustrophobia. DRUG: Chemotherapy, PROCEDURE: Computed Tomography, OTHER: Fludeoxyglucose F-18, PROCEDURE: Positron Emission Tomography, PROCEDURE: Surgical Procedure
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Positive Breast Carcinoma, Invasive Breast Carcinoma
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Show 102 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | |
| 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 Saint Luke's Medical Center Milwaukee, 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 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-Memphis Memphis, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Bryn Mawr Health Center Newtown Square, Pennsylvania | |
| Bryn Mawr Hospital Bryn Mawr, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Center-Metro Medical Center Bayamon Bayamón, | |
| 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) |
| Castle Medical Center Kailua, Hawaii | Site Public Contact - (ctsucontact@westat.com) |
| Centro Comprensivo de Cancer de UPR San Juan, | |
| Chester County Hospital West Chester, Pennsylvania | Site Public Contact - (carolann.hoppes@pennmedicine.upenn.edu) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| CoxHealth South Hospital Springfield, Missouri | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dell Seton Medical Center at The University of Texas Austin, Texas | |
| Doctors Cancer Center Manatí, | |
| FHCC South Lake Union Seattle, Washington | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| 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) |
| Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania | |
| 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) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Inspira Medical Center Mullica Hill Mullica Hill, New Jersey | Site Public Contact - (DeNigrisJ@ihn.org) |
| Inspira Medical Center Vineland Vineland, New Jersey | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kettering Medical Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Lankenau Medical Center Wynnewood, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| Louisiana State University Health Science Center New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| MD Anderson Cancer Center at Cooper-Voorhees Voorhees Township, New Jersey | |
| Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin | |
| Marshfield Clinic-Minocqua Center Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Ladysmith Ladysmith, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Neillsville Neillsville, Wisconsin | |
| 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 | |
| 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 in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| MetroHealth Medical Center Cleveland, Ohio | Site Public Contact - (ababal@metrohealth.org) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| 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 Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Paoli Memorial Hospital Paoli, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Riddle Memorial Hospital Media, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Saint John's Cancer Institute Santa Monica, California | |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| San Juan City Hospital San Juan, | |
| San Juan Community Oncology Group San Juan, | |
| Sibley Memorial Hospital Washington D.C., District of Columbia | Site Public Contact - (jquiver1@jhmi.edu) |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| United Hospital Saint Paul, Minnesota | |
| 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 - (tmyrick@uab.edu) |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| 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 at Austin Austin, Texas | Site Public Contact - (irb@austin.utexas.edu) |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii |
Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction (RANGER®)
Stacy Arnold - clinicalresearch@axogeninc.com
NCT01526681
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Primary Study Criteria (RANGER Avance):
Inclusion Criteria:
* Males and Females who have undergone nerve repair using the Avance® Nerve Graft for the repair of a nerve injury
* Returned for at least one post-operative follow-up visit
Exclusion Criteria:
• Subject who in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up.
Addendum 1 (MATCH) Criteria:
Inclusion Criteria:
* Have nerve transection injuries to the upper extremity;
* Have undergone tension free end to end nerve coaptation on both the proximal and distal portion of the nerve gap with nerve autograft or nerve entubulation with nerve tube conduit at a participating ANG-CP-005 registry site after 2004 and;
* Have completed sufficient follow-up assessments at a regeneration rate of 2mm/day to determine the outcomes of the repair or is willing to comply with site specific post-operative care procedures and assessments to determine the outcome of the repair.
Exclusion Criteria:
* Direct nerve repairs;
* Nerve gaps greater than 70mm;
* Subjects who, in the opinion of the investigator, were non-compliant to the investigator's post-operative treatment or rehabilitation instructions;
* Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.
Addendum 2 (Sensation-NOW) Criteria:
Inclusion Criteria:
* Female ≥ 18 years old
* Undergo post mastectomy autologous breast reconstruction with one type of autologous flap (no stacked reconstructions or use of implant with autologous flap)
* Neurotization must be completed using a donor nerve from the flap and a recipient nerve from the chest
* Complete Sensory Assessment Testing with Semmes Weinstein Monofilaments (SWMF) and the following Breast-Q Questionnaires 60 - 120 days post-reconstruction:
* Breast-Q Physical Well Being of the Chest
* Breast-Q Satisfaction with Breast
* Breast-Q Physical Well Being of the Abdomen
* Breast-Q Abnormal Breast Sensations
* Breast-Q Impact of Breast Sensation on Quality of Life
* Breast-Q Return of Breast Sensation
* Able to provide informed consent and are willing to comply with post-operative care procedures and assessments
Exclusion Criteria:
* Surgical history of secondary revision surgery for partial or total flap loss
* Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)
* Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy
* Currently undergoing IV chemotherapy or radiation
* Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule
Additional Eligibility criteria to Modules
Module 1: Native Skin Reconstructions with and without neurotization.
* Buried flap reconstructions from nipple sparing mastectomy or skin sparing mastectomy OR a breast reconstruction from a skin sparing mastectomy with exposed flap skin in the peri-areolar region.
* Sensory assessments must be completed on ≥ 8 Zones of Native Skin.
* Center zone measurement may be on either Native Skin or Flap Skin.
* All Inner and Outer zone measurements must be on Native Skin.
* De-identified photo of the breast reconstruction with 9 zones identified. OTHER: Processed Human Nerve Graft, OTHER: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc., OTHER: Autogenous Nerve Graft, DEVICE: Nerve Tube Conduit, PROCEDURE: Autologous Breast Reconstruction with Neurotization, PROCEDURE: Autologous Breast Reconstruction without Neurotization
Peripheral Nerve Injuries
Sensory Nerve, Mixed Nerve, Motor Nerve, Neurotization, Nerve Injury, Peripheral Nerve Injury
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Show 49 locations
Study Locations
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| Location | Contacts |
|---|---|
| MATCH: Hennepin County Medical Center Minneapolis, Minnesota | |
| RANGER & MATCH: Arizona Center for Hand Surgery Phoenix, Arizona | |
| RANGER & MATCH: Campbell Clinic Germantown, Tennessee | |
| RANGER & MATCH: Florida Orthopaedic Institute Tampa, Florida | |
| RANGER & MATCH: OrthoCarolina Research Institute, Inc. Charlotte, North Carolina | |
| RANGER & MATCH: The Buncke Clinic San Francisco, California | |
| RANGER & MATCH: University Hospital Birmingham, England Edgbaston, Birmingham | |
| RANGER & MATCH: University of California - Irvine Orange, California | |
| RANGER & MATCH: University of Kansas Medical Center Kansas City, Kansas | |
| RANGER & MATCH: University of Missouri - Columbia Columbia, Missouri | |
| RANGER & MATCH: University of Washington Seattle, Washington | |
| RANGER & MATCH: Vanderbilt University Nashville, Tennessee | |
| RANGER: Cleveland Clinic Cleveland, Ohio | |
| RANGER: Duke University Durham, North Carolina | |
| RANGER: Hand & Upper Extremity Center of Georgia/Children's Hospital of Atlanta Atlanta, Georgia | |
| RANGER: Johns Hopkins University Baltimore, Maryland | |
| RANGER: Multi-Disciplinary Specialists Rutherford, New Jersey | |
| RANGER: North York General Hospital Toronto, Ontario | |
| RANGER: Ohio State University Medical Center Columbus, Ohio | |
| RANGER: Phoenix Children's Hospital Phoenix, Arizona | |
| RANGER: San Antonio Military Medical Center San Antonio, Texas | |
| RANGER: Texas Tech University HSC Lubbock, Texas | |
| RANGER: University Hospital Vienna, | |
| RANGER: University of Cincinnati Cincinnati, Ohio | |
| RANGER: University of Kentucky Lexington, Kentucky | |
| RANGER: University of Miami Miami, Florida | |
| RANGER: University of North Texas/John Peter Smith Hospital Fort Worth, Texas | |
| RANGER: Walter Reed National Military Medical Center Bethesda, Maryland | |
| Sensation-NOW: Advanced Reconstructive Care, LLC Metairie, Louisiana | |
| Sensation-NOW: Baylor College of Medicine Houston, Texas | |
| Sensation-NOW: East Cooper Plastic Surgery Mount Pleasant, South Carolina | |
| Sensation-NOW: George Washington University Washington, District of Columbia | |
| Sensation-NOW: Houston-Methodist Central Houston, Texas | |
| Sensation-NOW: Houston-Methodist West/North Houston, Texas | |
| Sensation-NOW: Johns Hopkins University Baltimore, Maryland | |
| Sensation-NOW: Joshua Lemmon, MD, PLLC Richardson, Texas | |
| Sensation-NOW: Ohio State University Medical Center Columbus, Ohio | |
| Sensation-NOW: PRMA Plastic Surgery San Antonio, Texas | |
| Sensation-NOW: Stanford University Stanford, California | |
| Sensation-NOW: University of Cincinnati Cincinnati, Ohio | |
| Sensation-NOW: University of Colorado School of Medicine Aurora, Colorado | |
| Sensation-NOW: University of Kansas Medical Center Kansas City, Kansas | |
| Sensation-NOW: University of Nebraska Medical Center Omaha, Nebraska | |
| Sensation-NOW: University of Nevada, Las Vegas Las Vegas, Nevada | |
| Sensation-NOW: University of North Texas/John Peter Smith Hospital Fort Worth, Texas | |
| Sensation-NOW: University of Pennsylvania Philadelphia, Pennsylvania | |
| Sensation-NOW: University of Texas Southwestern Medical Center Dallas, Texas | |
| Sensation-NOW: Vanderbilt University Nashville, Tennessee | |
| Sensation-NOW: Virginia Commonwealth University Richmond, Virginia |
Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment
Brooke Burgess, MS - URCC_19185@urmc.rochester.edu
NCT04829539
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Inclusion Criteria:
* Be at least 18 years of age
* Be diagnosed with cancer (stage I, II, III, or IV) with a life expectancy of at least 12 months
* Be currently receiving any cancer treatment (surgery alone is excluded)
* Report sleep disturbance of 3 or greater on the sleep disturbance question: "Rate your sleep disturbance in the past 2 weeks on a scale from 0-10, 0 is no problems and 10 is having the most severe problems"
* Have a score of 2, 1, or 0 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
* Be able to speak, understand and read English to participate in the study assessments and interventions
Exclusion Criteria:
* Have a clinical diagnosis of obstructive sleep apnea or restless leg syndrome (even if controlled)
* Be engaged in a formal cognitive behavioral therapy for insomnia program presently or in the past 30 days. Use of sleep medications are allowed BEHAVIORAL: Behavioral Intervention, BEHAVIORAL: Behavioral Intervention, OTHER: Electronic Health Record Review, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
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Show 153 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| 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) |
| Bon Secours Saint Francis Hospital Charleston, South Carolina | |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| 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 Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia | Site Public Contact - (Kevin.Patel@centrahealth.com) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Charleston Oncology - Roper Charleston, South Carolina | |
| Charleston Oncology - Saint Francis Charleston, South Carolina | |
| Chesapeake Regional Medical Center Chesapeake, Virginia | Site Public Contact - (CancerCare@ChesapeakeRegional.com) |
| Christiana Care - Union Hospital Elkton, Maryland | Site Public Contact - (frank.crum@christianacare.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| 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) |
| HSHS Sacred Heart Hospital Eau Claire, Wisconsin | |
| 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) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hematology Oncology Associates of Fredericksburg Inc Fredericksburg, Virginia | Site Public Contact - (cvaughn@hoafredericksburg.com) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| 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) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Kaiser Permanente-Franklin Denver, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Lone Tree Lone Tree, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Rock Creek Lafayette, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Knox Community Hospital Mount Vernon, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Licking Memorial Hospital Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Louisiana State University Health Science Center New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Lowcountry Hematology Oncology PA-Mount Pleasant Mt. Pleasant, South Carolina | |
| Lowcountry Hematology Oncology PA-North Charleston Charleston, South Carolina | |
| Lowcountry Hematology Oncology PA-West Ashley Charleston, South Carolina | |
| Marietta Memorial Hospital Marietta, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Mercy Cancer Center-West Lakes Clive, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| 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 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 | Site Public Contact - (cancerresearch@mercydesmoines.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) |
| 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 Carmel East Hospital Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Carmel Grove City Hospital Grove City, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| 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 MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Outer Banks Hospital Nags Head, North Carolina | |
| 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 | |
| PeaceHealth Saint John Medical Center Longview, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | |
| PeaceHealth Southwest Medical Center Vancouver, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth United General Medical Center Sedro-Woolley, Washington | Site Public Contact - (rcrompton@peacehealth.org) |
| Physicians' Clinic of Iowa PC Cedar Rapids, Iowa | |
| 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 | |
| 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) |
| Roper Hospital Charleston, South Carolina | |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Saint Ann's Hospital Westerville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Louis Cancer and Breast Institute-Ballwin Ballwin, Missouri | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, 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 | |
| Shenandoah Oncology PC Winchester, Virginia | Site Public Contact - (William.Houck@usoncology.com) |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| The Cancer Center of Hawaii-Liliha Honolulu, Hawaii | |
| The Cancer Center of Hawaii-Pali Momi ‘Aiea, Hawaii | |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Tripler Army Medical Center Honolulu, Hawaii | |
| 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 - West Des Moines Clinic Clive, Iowa | |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Unity Hospital Fridley, Minnesota | |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| Valley Health / Winchester Medical Center Winchester, Virginia | |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Virginia Cancer Institute Richmond, Virginia | Site Public Contact - (smoore@vacancer.com) |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Waverly Hematology Oncology Cary, North Carolina | Site Public Contact - (TCHILDRESS@wakemed.org) |
Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Nat hx With Its Numerous Co-morbidities?
Gisela Chelimsky - Gisela.Chelimsky@vcuhealth.org
NCT06616363
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POTS sample
Inclusion Criteria:
* symptomatic ≥ 40 bpm rise in heart rate in the first 10 min of a tilt table study without a drop in blood pressure
* Clinical symptoms of orthostatic intolerance
Exclusion Criteria:
* Pregnant or breastfeeding
* Cognitive defects that preclude answering questionnaires or following assessment directions
* Other chronic diseases
* Unstable medical conditions
* Use of narcotics
* Limited English proficiency
* Investigator discretion that participant would not be suitable to participate
* A phone older than 5 years old or unable to support EMA software
POST INFECTION
Inclusion Criteria:
* acute upper respiratory or gastrointestinal infection that required admission to the acute care units but not requiring an ICU stay
Exclusion Criteria:
* Pregnant or breastfeeding
* Chronic prescriptions, history of POTS or orthostatic symptoms, recent inpatient psychiatric admissions, substance use disorder, trauma such as a motor vehicle accident, surgery, or other significant physical or emotional trauma in the last 5 years
* Cognitive defects that preclude answering questionnaires or following assessment directions
* Other unstable chronic diseases
* Unstable medical conditions
* Use of narcotics
* Severe depression or anxiety (untreated / unstable)
* Limited English proficiency
* Investigator discretion that participant would not be suitable to participate
* A phone older than 5 years old or unable to support EMA software
HEALTHY CONTROLS
Inclusion Criteria:
* Apparently healthy with no known chronic illnesses
Exclusion Criteria:
* Pregnant or breastfeeding
* History of POTS or orthostatic symptoms, migraines, fibromyalgia, chronic fatigue, PTSD. Functional gastrointestinal disorders, fainting, dysmenorrhea, or other chronic pain syndrome, inpatient psychiatric admissions, substance use disorder, trauma such as a motor vehicle accident, surgery, or other significant physical or emotional trauma in the last 5 years
* Cognitive defects that preclude answering questionnaires or following assessment directions
* Other chronic unstable diseases
* Unstable medical conditions
* Use of narcotics
* Severe depression or anxiety (untreated / unstable)
* Limited English proficiency
* Investigator discretion that participant would not be suitable to participate
* A phone older than 5 years old or unable to support EMA software BEHAVIORAL: Questionnaires to be competed, BEHAVIORAL: Provide list of medication and lifetime events, BEHAVIORAL: Use phone App to record new life events, DEVICE: Will wear an activity monitor, OTHER: Periodic 24-hour urine sodium check, DIAGNOSTIC_TEST: A fMRI scan, DIAGNOSTIC_TEST: A bedside tilt test will be performed, OTHER: IV placed to collect blood samples, OTHER: Stool Sample
POTS - Postural Orthostatic Tachycardia Syndrome
PAG activation, Cardiovagal Modulation
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Gisela Chelimsky - (Gisela.Chelimsky@vcuhealth.org) Bhakti Dave, - (bhakti.dave@vcuhealth.org) |
Heuristic Tool To Improve Symptom Self-Management in Adolescents and Young Adults With Cancer
Grace Hodges - hodgesg@vcu.edu
NCT05958316
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Inclusion Criteria:
* Has received at least 1 cycle of cancer treatment and is within 3 months of initial cancer diagnosis
* Receiving regularly scheduled cancer treatment and will be receiving at least three more cycles
* Reports at least 1 symptom related to cancer and/or its treatment
* Able to speak, read, and write English as required for completion of the C-SCAT and study measures
Exclusion Criteria:
\- Cognitive and/or physical inability to complete study measures. BEHAVIORAL: Computerized Symptom Capture Tool (C-SCAT) Intervention, BEHAVIORAL: Usual Care Control
Symptoms and Signs, Cancer, Childhood Cancer
Supportive Care, Symptom Management
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Study Locations
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| Location | Contacts |
|---|---|
| Children's Mercy Hospital Kansas City, Missouri | Kristin Stegenga - (kstegenga@cmh.edu) |
| Seattle Children's Hospital @ University of Washington Seattle, Washington | Catherine F Macpherson - (CatherineFiona.Macpherson@seattlechildrens.org) |
| University of Utah Primary Children's Hospital Salt Lake City, Utah | Lauri Linder - (lauri.linder@nurs.utah.edu) |
| Virginia Commonwealth University Richmond, Virginia | Grace Hodges - (rkelswic@vcu.edu) |
Mobile Health for Adherence in Breast Cancer Patients
ctrrecruit@vcu.edu
NCT06112613
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Inclusion Criteria:
* NON-PATIENT: Participants must be an oncology healthcare provider (i.e., oncologist, advanced practice provider, or oncology nurse)
* NON-PATIENT: Participants must have taken care of at least one patient randomized to Arm B (CONCURxP) who had less than 85% adherence rate at 12 months as measured by the WiseBag
* NON-PATIENT: Participant must speak English
* NON-PATIENT: Participant must be employed at an National Cancer Institute Community Oncology Research Program (NCORP) site for at least 6 months
* NON-PATIENT: Participant must be able to provide informed consent to participate in this study
* PATIENT STEP 0: Patient must be \>= 18 years of age
* PATIENT STEP 0: Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish
* PATIENT STEP 0: Patient must present with new or established pathologically proven hormone receptor (HR)+ HER2- metastatic breast cancer at the time of Step 0
* PATIENT STEP 0: Patient must have initiated any of the CKD4/6 inhibitors (palbociclib or Ibrance, ribociclib or Kisqali, abemaciclib or Verzenio) within 30 days prior to consenting to Step 0 or have received a prescription order with stated intent to initiate within 30 days following Step 0 consent
* NOTE: Patients who have been treated previously with anticancer treatments other than CDK4/6 inhibitors are eligible
* NOTE: CDK4/6 inhibitors must be provided/supplied as a single agent blister pack. If the medication is supplied as capsules in a pill bottle (e.g., Ibrance capsules), patient is not eligible
* NOTE: Ribociclib (Kisqali) and abemaciclib (Verzenio) are only available in blister packs. Palbociclib (Ibrance) is the only CDK4/6 inhibitor that might be available in a capsule formulation. However, this is an outdated formulation and is rarely prescribed as a new start. The format of ordered palbociclib can be determined based on the prescription order
* PATIENT STEP 0: Patients must not have been previously treated with any of the following CDK4/6 inhibitors: Palbociclib or Ibrance, ribociclib or Kisqali, and abemaciclib or Verzenio
* PATIENT STEP 0: Patients must not already be enrolled in a therapeutic clinical trial that monitors CDK4/6 inhibitors
* PATIENT STEP 0: Patient must confirm that they intend to receive their care or monitoring at an NCORP site
* PATIENT STEP 0: Patient must have a personal mobile phone in which they are able and willing to send and receive text messages
* NOTE: The restriction to those with mobile phone access with text messaging is based on the primary intention of the study which involves the use of text messaging to improve adherence
* PATIENT STEP 0: Patient must have an email address
* NOTE: The restriction to those with an email address is based on the primary intention of the study which involves patients responding to questions regarding their reasons for non-adherence after every missed dose to improve adherence
* PATIENT STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document
* NOTE: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available are not eligible
* PATIENT STEP 0: Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status \>= 3 OR patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice)
* PATIENT STEP 0: Patient must not be enrolled in other trials offering financial assistance
* NOTE: Gift cards for survey completion, parking passes, or free medication provided as part of therapeutic trials are not considered financial assistance
* PATIENT STEP 1: Patient must meet all the eligibility criteria for Step 0
* PATIENT STEP 1: Patient must have signed a written informed consent form
* PATIENT STEP 1: Patient must have completed baseline survey within 30 days of the date of Step 0 Registration
* PATIENT STEP 1: Patients must have initiated their CDK 4/6 inhibitors within 30 days of the date of Step 0 registration OTHER: Electronic Health Record Review, OTHER: Health Promotion and Education, PROCEDURE: Health Telemonitoring, OTHER: Interview, BEHAVIORAL: Patient Navigation, OTHER: Survey Administration, OTHER: Text Message-Based Navigation Intervention
Anatomic Stage IV Breast Cancer AJCC v8, Breast Carcinoma, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma
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Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Academic Hematology Oncology Specialists Grosse Pointe Woods, Michigan | |
| Advanced Breast Care Center PLLC Warren, Michigan | |
| 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) |
| Alegent Health Mercy Hospital Council Bluffs, Iowa | |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Ann M Wierman MD LTD Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Armes Family Cancer Center Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Ascension All Saints Hospital Racine, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Borgess Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Ascension Calumet Hospital Chilton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Columbia Saint Mary's Hospital Ozaukee Mequon, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Mercy Hospital Oshkosh, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Elizabeth Hospital Appleton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Francis - Reiman Cancer Center Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Saint Francis Hospital Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Saint John Hospital Detroit, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Ascension Saint Joseph Hospital Tawas City, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Ascension Saint Mary's Hospital Saginaw, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital - Franklin Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BASS Medical Group - Lennon Walnut Creek, California | Site Public Contact - (brenna.lindsey@bassmedicalgroup.com) |
| Ballad Health Cancer Care - Kingsport Kingsport, Tennessee | Site Public Contact - (Justin.reynolds@balladhealth.org) |
| 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) |
| 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) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bethesda North Hospital Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Billings Clinic-Cody Cody, Wyoming | Site Public Contact - (research@billingsclinic.org) |
| Blanchard Valley Hospital Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia | Site Public Contact - (Anne_caramella@bshsi.org) |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Richmond Community Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Westchester Emergency Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Borgess Medical Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Boulder Community Foothills Hospital Boulder, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bristol Regional Medical Center Bristol, Tennessee | Site Public Contact - (justin.reynolds@wellmont.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) |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| CHI Health Good Samaritan Kearney, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cambridge Medical Center Cambridge, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| 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 and Blood Specialists-Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.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) |
| Caro Cancer Center Caro, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| 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) |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Cheyenne Regional Medical Center-West Cheyenne, Wyoming | |
| Chilton Medical Center Pompton, New Jersey | |
| 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) |
| Colorado Blood Cancer Institute Denver, Colorado | |
| 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 Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Contra Costa Regional Medical Center Martinez, California | |
| 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) |
| Dayton Physician LLC - Englewood Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC - Troy Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Atrium Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Miami Valley South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Wayne Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Delbert Day Cancer Institute at PCRMC Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Doctors Cancer Center Manatí, | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Fairbanks Memorial Hospital Fairbanks, Alaska | Site Public Contact - (Veronica.Stevenson@foundationhealth.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) |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| 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) |
| Genesee Cancer and Blood Disease Treatment Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesee Hematology Oncology PC Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| GenesisCare USA - Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Las Vegas Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Vegas Tenaya Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Good Samaritan Regional Health Center Mount Vernon, Illinois | |
| Great Falls Clinic Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Great Lakes Cancer Management Specialists-Doctors Park East China, Michigan | |
| Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb, Michigan | |
| Great Lakes Cancer Management Specialists-Macomb Professional Building Warren, Michigan | |
| Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods, Michigan | |
| Greater Dayton Cancer Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Hackettstown Medical Center Hackettstown, New Jersey | |
| Health Partners Inc Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (linda.schumacher@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) |
| Holy Cross Hospital Silver Spring, Maryland | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Center Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Idaho Urologic Institute-Meridian Meridian, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Jefferson Healthcare Port Townsend, Washington | |
| Kaiser Permanente - Harbor City Harbor City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, 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-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-Franklin Denver, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-Irvine Irvine, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Lone Tree Lone Tree, Colorado | Site Public Contact - (kristi.m.bronkan@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-Rock Creek Lafayette, Colorado | Site Public Contact - (kristi.m.bronkan@kp.org) |
| Kaiser Permanente-San Diego Mission San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Kalispell Regional Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Kettering Medical Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.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) |
| Las Vegas Prostate Cancer Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Cathedral Rock Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pebble Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pecos Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Smoke Ranch Las Vegas, Nevada | Site Public Contact - (research@smcrf.org) |
| Las Vegas Urology - Sunset Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| 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) |
| Longmont United Hospital Longmont, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Louisiana Hematology Oncology Associates Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Louisiana Hematology Oncology Associates LLC Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| 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) |
| Macomb Hematology Oncology PC Warren, Michigan | |
| Maimonides Medical Center Brooklyn, New York | |
| Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Minocqua Center Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Wausau Center Wausau, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Ladysmith Ladysmith, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Neillsville Neillsville, 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) |
| Mary Bird Perkins Cancer Center Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Mary Greeley Medical Center Ames, Iowa | |
| 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 Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Mercy Cancer Center Merced, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| 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 Health - Paducah Medical Oncology and Hematology Paducah, Kentucky | Site Public Contact - (BJWarner@mercy.com) |
| 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 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 Medical Center Baltimore, Maryland | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (OncologyResearch@DignityHealth.org) |
| Michigan Breast Specialists-Warren Warren, Michigan | |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Midlands Community Hospital Papillion, Nebraska | |
| 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 Cancer and Blood - Ankeny Ankeny, Iowa | |
| Mission Cancer and Blood - Des Moines Des Moines, Iowa | |
| 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) |
| Mississippi Baptist Medical Center Jackson, Mississippi | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| 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) |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Morristown Medical Center Morristown, New Jersey | |
| Mountain Blue Cancer Care Center - Swedish Englewood, Colorado | |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas | Site Public Contact - (Emily.Carvell@bmhcc.org) |
| 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) |
| Newton Medical Center Newton, New Jersey | |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| 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 MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Orion Cancer Care Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Overlook Hospital Summit, New Jersey | |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| 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) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Phoebe Putney Memorial Hospital Albany, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Puerto Rico Hematology Oncology Group Bayamón, | |
| Radiation Oncology Associates Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reid Health Richmond, Indiana | Site Public Contact - (clinical.trials@daytonncorp.org) |
| 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) |
| Rocky Mountain Cancer Centers - Centennial Centennial, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers - Swedish Englewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Aurora Aurora, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Boulder Boulder, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Littleton Littleton, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Longmont Longmont, Colorado | Site Public Contact - (ResearchTracking@Centura.Org) |
| Rocky Mountain Cancer Centers-Midtown Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Rocky Mountain Cancer Centers-Rose Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Thornton Thornton, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rush - Copley Medical Center Aurora, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| 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 Hospital Lakewood, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Anthony's Health Alton, Illinois | |
| Saint Elizabeth Boardman Hospital Boardman, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Elizabeth Regional Medical Center Lincoln, Nebraska | |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint John Macomb-Oakland Hospital Warren, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital Nashua, New Hampshire | 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 Warren Hospital Warren, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Louis Cancer and Breast Institute-Ballwin Ballwin, Missouri | |
| Saint Louis Cancer and Breast Institute-South City St Louis, Missouri | |
| Saint Mary Corwin Medical Center Pueblo, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Mary's Hospital Rhinelander, Wisconsin | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Saint Michael Cancer Center Silverdale, Washington | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| 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 Cancer Center Worthington Worthington, Minnesota | |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Medical Center Fargo Fargo, North Dakota | |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford South University Medical Center Fargo, North Dakota | |
| Sanford Thief River Falls Medical Center Thief River Falls, Minnesota | |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Shenandoah Oncology PC Winchester, Virginia | Site Public Contact - (William.Houck@usoncology.com) |
| South Georgia Medical Center/Pearlman Cancer Center Valdosta, Georgia | Site Public Contact - (maryann.heddon@sgmc.org) |
| Southpointe-Sanford Medical Center Fargo Fargo, North Dakota | |
| Southwest Oncology PC Durango, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Southwest VA Regional Cancer Center Norton, Virginia | Site Public Contact - (justin.reynolds@wellmont.org) |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Terrebonne General Medical Center Houma, Louisiana | Site Public Contact - (ann.hooks@tgmc.com) |
| The Melanoma and Skin Cancer Institute Englewood, Colorado | Site Public Contact - (ryan.weight@theskincancerinstitute.com) |
| The Women's Imaging Center Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| ThedaCare Cancer Care - Berlin Berlin, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - New London New London, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Shawano Shawano, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Waupaca Waupaca, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Medical Center - Neenah Neenah, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| 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 Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Cancer Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| 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 New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| Urology Specialists of Nevada - Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Walter Knox Memorial Hospital Emmett, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Wayne Hospital Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Welch Cancer Center Sheridan, Wyoming | Site Public Contact - (mccinfo@mtcancer.org) |
| Wellmont Holston Valley Hospital and Medical Center Kingsport, Tennessee | Site Public Contact - (justin.reynolds@wellmont.org) |
| Wellmont Medical Associates-Bristol Bristol, Virginia | Site Public Contact - (justin.reynolds@wellmont.org) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Woodland Memorial Hospital Woodland, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring
ctrrecruit@vcu.edu
NCT04597359
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Inclusion Criteria:
* INCLUSION CRITERIA FOR PREREGISTRATION (STEP 0: SCREENING)
* Patient must have biopsy-proven (consisting of \>= 12 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core in the most recent biopsy using initial transrectal ultrasound (TRUS) biopsy or TRUS biopsy followed by multiparametric magnetic resonance imaging (mpMRI) of the prostate and a confirmatory targeted biopsy
* Patient must be on active surveillance (very low, low and favorable intermediate risk as defined by the National Comprehensive Cancer Network \[NCCN\])
* Patient must be scheduled for a follow up prostate biopsy 6 months after the initiation of treatment on this study
* Patient must have a serum PSA \< 10 ng/mL or prostate specific antigen density (PSAD) \< 0.15 ng/mL/ g obtained within 30 days of registration
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patient must be willing to abstain from consumption of any supplements containing green tea catechins
* Patient must be willing to restrict tea consumption to less than three (3) servings of hot tea or three (3) servings of iced tea per week (serving size of 8 oz)
* Patient must be willing to discontinue current vitamin/mineral supplement use and use one provided by study
* Patient must be willing to take study agent or placebo at the dose specified with meals
* Patient must have the ability to understand and the willingness to sign a written informed consent document
* Absolute neutrophil count \>= 1,200/mm\^3 (\>= 1.2 k/uL) (obtained within 30 days prior to registration)
* Platelets \>= 75,000/mm\^3 (\>= 75 k/uL) (obtained within 30 days prior to registration)
* Total bilirubin =\< 1.2 mg/dL (or =\< 3.0 mg/dL for patients with Gilbert's syndrome) (obtained within 30 days prior to registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x upper limit of normal (ULN) (obtained within 30 days prior to registration)
* Serum creatinine =\< 1.5 x ULN (obtained within 30 days prior to registration)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Sexually active males must use an accepted and effective method of double barrier contraception (vasectomy must be combined with a physical barrier method) or abstain from sexual intercourse for the duration of their participation in the study
* Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen available for Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue for eligibility and stratification. Tumor tissue can be submitted any time during screening
* Tumor tissue specimen has been collected and is ready to ship to H. Lee Moffitt Cancer Center \& Research Institute
* H. Lee Moffitt Cancer Center \& Research Institute will perform Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue and notify the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Operations Office and submitting institution within 3-4 business days of receipt of the tumor tissue specimen
* INCLUSION CRITERIA FOR RANDOMIZATION (STEP 1)
* Patient must meet all Step 0 eligibility criteria at the time of their registration to Step 1
* Patient must have Gleason score (3+3) or predominant Gleason pattern 3 (3+4), =\< 33% of biopsy cores, and =\< 50% involvement of any biopsy core
* Patient must have % Ki-67 expression of 5% or more in tumor tissue
Exclusion Criteria:
* EXCLUSION CRITERIA FOR PREREGISTRATION (STEP 0: SCREENING)
* Patient must not have had prior treatment for prostate cancer, including focal therapy, with surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen deprivation therapy
* Patient must not have a history of renal or hepatic disease, including history of hepatitis B and C
* Patient must not have prostate cancer with distant metastases
* Patient must not have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years. 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
* Patient must not receive any other investigational agents while on this study
* Patient must not have a history of allergic reactions attributed to tea or other compounds of similar chemical or biologic composition to green tea extracts DRUG: Placebo Administration, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, DRUG: Sinecatechins
Prostate Carcinoma
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Show 353 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Academic Hematology Oncology Specialists Grosse Pointe Woods, Michigan | |
| Advanced Breast Care Center PLLC Warren, Michigan | |
| 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) |
| Alegent Health Mercy Hospital Council Bluffs, Iowa | |
| Alta Bates Summit Medical Center - Summit Campus Oakland, California | |
| Armes Family Cancer Center Findlay, Ohio | |
| Ascension Saint John Hospital Detroit, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Ascension Saint Joseph Hospital Tawas City, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Ascension Saint Mary's Hospital Saginaw, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | |
| Audie L Murphy VA Hospital San Antonio, Texas | |
| BASS Medical Group - Lennon Walnut Creek, California | Site Public Contact - (brenna.lindsey@bassmedicalgroup.com) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Bay Area Breast Surgeons Inc Emeryville, California | |
| Bay Area Tumor Institute Oakland, California | |
| Bethesda North Hospital Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan | |
| Blanchard Valley Hospital Findlay, Ohio | |
| Boulder Community Foothills Hospital Boulder, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Broadlawns Medical Center Des Moines, Iowa | |
| 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 Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas | |
| Cambridge Medical Center Cambridge, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| 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 - (ecog.rss@jimmy.harvard.edu) |
| 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, | |
| 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) |
| Caro Cancer Center Caro, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Castle Medical Center Kailua, Hawaii | |
| 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 - (ecog.rss@jimmy.harvard.edu) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Chesapeake Regional Medical Center Chesapeake, Virginia | Site Public Contact - (CancerCare@ChesapeakeRegional.com) |
| Cheyenne Regional Medical Center-West Cheyenne, Wyoming | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Commonwealth Cancer Center-Corbin Corbin, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Contra Costa Regional Medical Center Martinez, California | |
| 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) |
| Dayton Physician LLC - Englewood Dayton, Ohio | |
| Dayton Physicians LLC - Troy Troy, Ohio | |
| Dayton Physicians LLC-Atrium Franklin, Ohio | |
| Dayton Physicians LLC-Miami Valley South Centerville, Ohio | |
| Dayton Physicians LLC-Wayne Greenville, Ohio | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delbert Day Cancer Institute at PCRMC Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Doctors Cancer Center Manatí, | |
| Elmhurst Hospital Center Elmhurst, New York | |
| Epic Care Cyberknife Center Walnut Creek, California | |
| Epic Care Partners in Cancer Care Emeryville, California | |
| Epic Care-Dublin Dublin, California | |
| FHP Health Center-Guam Tamuning, | |
| Fairbanks Memorial Hospital Fairbanks, Alaska | Site Public Contact - (Veronica.Stevenson@foundationhealth.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 Ridges Hospital Burnsville, Minnesota | |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Flaget Memorial Hospital Bardstown, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington | |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Genesee Cancer and Blood Disease Treatment Center Flint, Michigan | Site Public Contact - (wstrong@ghci.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) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Good Samaritan Regional Health Center Mount Vernon, Illinois | |
| Great Lakes Cancer Management Specialists-Doctors Park East China, Michigan | |
| Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb, Michigan | |
| Great Lakes Cancer Management Specialists-Macomb Professional Building Warren, Michigan | |
| Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods, Michigan | |
| Greater Dayton Cancer Center Kettering, Ohio | |
| Greater Regional Medical Center Creston, Iowa | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | |
| Hawaii Cancer Care Inc-Liliha Honolulu, Hawaii | |
| Hawaii Diagnostic Radiology Services LLC Honolulu, Hawaii | |
| Health Partners Inc Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (linda.schumacher@mymlc.com) |
| Hematology Oncology Consultants-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Hickman Cancer Center Adrian, Michigan | |
| Highlands Oncology Group Springdale, Arkansas | |
| Highlands Oncology Group - Fayetteville Fayetteville, Arkansas | |
| Highlands Oncology Group - Rogers Rogers, Arkansas | |
| Highline Medical Center-Main Campus Burien, Washington | |
| Holy Cross Hospital Silver Spring, Maryland | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hope Cancer Center Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hope Cancer Clinic Livonia, Michigan | |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.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) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Inova Alexandria Hospital Alexandria, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Fair Oaks Hospital Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| 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 Lutheran Hospital Des Moines, Iowa | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| James J Peters VA Medical Center The Bronx, New York | Site Public Contact - (kl2965@cumc.columbia.edu) |
| Jefferson Healthcare Port Townsend, Washington | |
| Jewish Hospital Louisville, Kentucky | |
| Jewish Hospital Medical Center South Shepherdsville, Kentucky | |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kettering Medical Center Kettering, Ohio | |
| Kuakini Medical Center Honolulu, Hawaii | |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| 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) |
| Lexington Medical Center West Columbia, South Carolina | Site Public Contact - (research@lexhhealth.org) |
| Littleton Adventist Hospital Littleton, Colorado | |
| Longmont United Hospital Longmont, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| Macomb Hematology Oncology PC Warren, Michigan | |
| Maine Medical Partners Urology South Portland, Maine | Site Public Contact - (ClinicalResearch@mmc.org) |
| Marshall Cancer Center Cameron Park, California | Site Public Contact - (cancerservices@marshallmedical.org) |
| Marshall Hospital Placerville, California | Site Public Contact - (cancerservices@marshallmedical.org) |
| Mary Greeley Medical Center Ames, Iowa | |
| 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 University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Medical Center Modesto, California | Site Public Contact - (pallante.beth@mhsil.com) |
| Mercy Cancer Center Merced, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| 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 Cancer Center-West Lakes Clive, Iowa | |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Health - Paducah Medical Oncology and Hematology Paducah, Kentucky | Site Public Contact - (BJWarner@mercy.com) |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | |
| 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 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 Medical Center Baltimore, Maryland | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (OncologyResearch@DignityHealth.org) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Methodist West Hospital West Des Moines, Iowa | |
| Miami Valley Hospital Dayton, Ohio | |
| Miami Valley Hospital North Dayton, Ohio | |
| Miami Valley Hospital South Centerville, Ohio | |
| Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods, Michigan | |
| Michigan Breast Specialists-Macomb Township Macomb, Michigan | |
| Michigan Breast Specialists-Warren Warren, Michigan | |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Midlands Community Hospital Papillion, Nebraska | |
| 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 Cancer and Blood - Ankeny Ankeny, Iowa | |
| Mission Cancer and Blood - Des Moines Des Moines, Iowa | |
| Mission Cancer and Blood - Laurel Des Moines, Iowa | |
| Mission Cancer and Blood - West Des Moines Clive, Iowa | |
| 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 Comprehensive Cancer Center at Aventura Aventura, Florida | Site Public Contact - (yenrique@msmc.com) |
| Mount Sinai Medical Center Miami Beach, Florida | Site Public Contact - (yenrique@msmc.com) |
| Mountain Blue Cancer Care Center - Swedish Englewood, Colorado | |
| Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska | |
| New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire | |
| 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) |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio | |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Orion Cancer Care Findlay, Ohio | |
| Outer Banks Hospital Nags Head, North Carolina | Site Public Contact - (research@vidanthealth.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 | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parker Adventist Hospital Parker, Colorado | |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Porter Adventist Hospital Denver, Colorado | |
| Portland VA Medical Center Portland, Oregon | |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado | Site Public Contact - (info@westernstatesncorp.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 | |
| Queens Hospital Center Jamaica, New York | |
| Ralph H Johnson VA Medical Center Charleston, South Carolina | Site Public Contact - (ashley.salvo@va.gov) |
| Reading Hospital West Reading, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reid Health Richmond, Indiana | |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rocky Mountain Cancer Centers - Centennial Centennial, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers - Swedish Englewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Aurora Aurora, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Boulder Boulder, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Littleton Littleton, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Longmont Longmont, Colorado | Site Public Contact - (ResearchTracking@Centura.Org) |
| Rocky Mountain Cancer Centers-Midtown Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Rocky Mountain Cancer Centers-Rose Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Thornton Thornton, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Regional VA Medical Center Aurora, Colorado | |
| Rose Medical Center Denver, Colorado | |
| Rush - Copley Medical Center Aurora, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Saint Anthony Hospital Lakewood, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Anthony Regional Hospital Carroll, Iowa | Site Public Contact - (sbenson@iora.org) |
| Saint Anthony's Health Alton, Illinois | |
| Saint Clare Hospital Lakewood, Washington | |
| Saint Elizabeth Boardman Hospital Boardman, Ohio | |
| Saint Elizabeth Hospital Enumclaw, Washington | |
| Saint Elizabeth Regional Medical Center Lincoln, Nebraska | |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Francis Hospital Federal Way, Washington | |
| 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 John Macomb-Oakland Hospital Warren, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital Nashua, New Hampshire | 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 Regional Cancer Center Bryan, Texas | |
| Saint Joseph Warren Hospital Warren, Ohio | |
| Saint Louis Cancer and Breast Institute-Ballwin Ballwin, Missouri | |
| Saint Louis Cancer and Breast Institute-South City St Louis, Missouri | |
| Saint Mary Corwin Medical Center Pueblo, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Mary's Hospital Rhinelander, Wisconsin | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Saint Michael Cancer Center Silverdale, Washington | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Peter's University Hospital New Brunswick, New Jersey | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Saints Mary and Elizabeth Hospital Louisville, Kentucky | |
| San Juan City Hospital San Juan, | |
| San Juan Community Oncology Group San Juan, | |
| Solinsky Center for Cancer Care Manchester, New Hampshire | |
| Southeast Cancer Center Cape Girardeau, Missouri | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southwest Oncology PC Durango, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Sovah Health Martinsville Martinsville, Virginia | Site Public Contact - (sharon.hubbard@lpnt.net) |
| Springfield Clinic Springfield, Illinois | |
| Springfield Regional Cancer Center Springfield, Ohio | |
| Springfield Regional Medical Center Springfield, Ohio | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Straub Medical Center - Kahului Clinic Kahului, Hawaii | |
| Straub Pearlridge Clinic ‘Aiea, Hawaii | |
| Swedish Medical Center Englewood, Colorado | |
| The Cancer Center of Hawaii-Liliha Honolulu, Hawaii | |
| The Cancer Center of Hawaii-Pali Momi ‘Aiea, Hawaii | |
| The Carle Foundation Hospital Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| The Melanoma and Skin Cancer Institute Englewood, Colorado | Site Public Contact - (ryan.weight@theskincancerinstitute.com) |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | |
| The Women's Imaging Center Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Toledo Clinic Cancer Centers-Maumee Maumee, Ohio | Site Public Contact - (pshoup@toledoclinic.com) |
| Toledo Clinic Cancer Centers-Monroe Monroe, Michigan | |
| Toledo Clinic Cancer Centers-Toledo Toledo, Ohio | |
| 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 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) |
| Trinity Regional Medical Center Fort Dodge, Iowa | |
| 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) |
| UCHealth - Cherry Creek Denver, Colorado | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCSF Cancer Center - San Mateo San Mateo, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Unity Hospital Fridley, Minnesota | |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| 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 Texas Health Science Center at San Antonio San Antonio, Texas | |
| UofL Health Medical Center Northeast Louisville, Kentucky | |
| Upper Valley Medical Center Troy, Ohio | |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | |
| Valley Radiation Oncology Peru, Illinois | |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | |
| Wayne Hospital Greenville, Ohio | |
| Western Illinois Cancer Treatment Center Galesburg, Illinois | |
| Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii | |
| Woodland Memorial Hospital Woodland, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
Cardiovascular Health & Early Stress
Paula Rodriguez Miguelez - prodriguezmig@vcu.edu
NCT06557707
Show full eligibility criteria
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Inclusion Criteria:
Cohort 1
* Men and pre-menopausal women
* 18-30 years old
Cohort 2
* males and females
* 9-17 years old
Exclusion Criteria:
Cohort 1
* Evidence of cardiovascular, pulmonary, renal, hepatic or cerebral diseases
* Evidence of pregnancy or currently nursing.
* Having a history of chronic pain
* Having a history of rheumatoid arthritis
Cohort 2
* Evidence of cardiovascular, pulmonary, renal, hepatic or cerebral diseases
* Evidence of pregnancy or currently nursing.
* Having a history of chronic pain
* Having a history of rheumatoid arthritis OTHER: Childhood stress
Stress
I'm interested
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Show 1 location
Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Paula Rodriguez Miguelez - (prodriguezmig@vcu.edu) |
Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder
Tiffany Pignatello, FNP - study4u@vcu.edu
NCT05886582
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Male or female subjects between 25 and 70 years of age.
* Meet current DSM-5 criteria for Cocaine Use Disorder (CocUD), moderate or severe
* Able to understand and comply with study procedures
* Have positive urine result for cocaine metabolite benzoylecgonine (BE) during at least one screening visit (out of up to three visits, depending on participants' preference) AND/OR self-report of recent cocaine use (approximately past 30 days).
* Have hematology and chemistry laboratory tests that are within normal limits, except that liver function tests must be no more than 2x of the upper limit of normal (if any elevation is above the limit - must be judged by the study physician to be clinically insignificant).
* No clinically significant abnormalities on baseline ECG.
* Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory and fMRI testing.
* Women must either be unable to conceive (i.e., surgically sterilized, sterile, or postmenopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device with spermicide, or condoms). Men will be advised to use condoms. All females must provide negative pregnancy urine tests before study entry, at each visit during the study, and the end of study participation.
* Body Mass Index (BMI) between 18-45kg/M2 and weight of at least 50kg at screening
Exclusion Criteria:
* Have concurrent secondary DSM-5 diagnosis of any psychoactive substance use disorder other than cocaine, alcohol, methamphetamine, nicotine, opioid, or marijuana use disorder.
* Have a DSM-5 axis I psychiatric disorder other than substance use disorder, including but not limited to Bipolar I Disorder, Schizophrenia, or other psychotic disorder that require treatment with antipsychotics, or a neurological disorder requiring ongoing treatment and/or making study participation unsafe. Comorbid PTSD, Generalized Anxiety Disorder and Major Depressive Disorder will be allowed.
* Consistent and regular (as opposed to intermittent, infrequent, or as needed) use of medications contraindicated for concurrent use along with RTG, or would confound the mechanism of RTG action and data interpretation. These include DA antagonists such as antipsychotic medications (especially neuroleptics) or metoclopramide.
* Subjects with evidence or history of any clinically significant medical disorder including biliary obstruction, clinically significant hepatic disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal, or endocrine disease. However, controlled hypertension, controlled hypothyroidism, and cancer in remission over 5 years will not be excluded.
* Have a history of seizures (excluding childhood febrile seizures) or loss of consciousness (e.g. from traumatic brain injury) for more than 30 minutes.
* Have significant current suicidal or homicidal ideation or a suicide attempt within the past 6 months, based on the Columbia Suicide Severity Rating Scale (C-SSRS).
* Be HIV positive by self-report or history.
* Be pregnant or nursing or not using a reliable form of contraception if able to conceive. All females must provide negative pregnancy urine tests before study entry, at each visit during the study, and the end of study participation
* Have any other illness, or condition, which in the opinion of the clinical co-investigator (Arias) would preclude safe and/or successful completion of the study.
* Be allergic to rotigotine.
* Have taken any investigational drug within 45 days prior to baseline
* Demonstrate intolerance to, poor adherence to, or extreme skin irritation by daily application of known placebo "practice" skin patches during the screening phase
* Current/pending criminal charges that may result in incarceration within the next 60 days
* Self-report of allergic or other reactions to sulfites (e.g. in foods) DRUG: Rotigotine Transdermal System [Neupro], DRUG: Placebo
Substance-Related Disorders
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Tiffany Pignatello, NP - (tfitz@vcu.edu) Lori Keyser-Marcus, PhD - (lakeyser@vcu.edu) |
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study (STOP360AG)
Rachael Buckingham, BS - Rachael.buckingham@seattlechildrens.org
NCT05548283
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Inclusion Criteria:
* All genders ≥ 6 years of age at Visit 1
* Documentation of a CF diagnosis
* Clinician intent to treat index CF PEx with a planned 14-day course of IV antimicrobials
* At least one documented Pa positive culture within two years prior to Visit 1
Exclusion Criteria:
* Participant is not pregnant
* No known renal impairment or history of solid organ transplantation
* No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6 weeks prior to Visit 1
* No use of investigational therapies, new CF transmembrane conductance regulator (CFTR) modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to Visit 1
* No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides
* No more than one day of IV aminoglycosides administered for the current PEx treatment prior to Visit 1 DRUG: Beta-lactam antibiotic, DRUG: Aminoglycoside
Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
Cystic Fibrosis, CF, Cystic Fibrosis Pulmonary Exacerbation, aminoglycoside, beta-lactam, β-lactam, STOP, STOP360
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Study Locations
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| Location | Contacts |
|---|---|
| All Children's Hospital St. Petersburg, Florida | Diana Hodge - (dhodge6@jhmi.edu) |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | Yung Hsuan (Irene) Wu - (yhwu@luriechildrens.org) |
| Billings Clinic Billings, Montana | Jerimiah Lysinger - (JLysinger@billingsclinic.org) |
| Boston Children's Hospital, Brigham & Women's Hospital Boston, Massachusetts | Robert Fowler - (Robert.fowler@childrens.harvard.edu) |
| CHOC Children's Hospital Orange, California | Lila Klein - (Lila.klein@choc.org) |
| Children's Hospital Medical Center Of Akron Akron, Ohio | Michelle Parrish - (MParrish@akronchildrens.org) |
| Children's Hospital of New York New York, New York | Hossein Sadeghi - (HS762@cumc.Columbia.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Elizabeth Hartigan - (elizabeth.hartigan@chp.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Jack Serio - (jserio@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Kelly Thornton - (Kelly.Thornton@cchmc.org) |
| Cook Children's Medical Center Fort Worth, Texas | Jill Finto - (jill.finto@cookchildrens.org) |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | Barbara A Rodgers - (Barbara.A.Rodgers@hitchcock.org) |
| Dayton Children's Hospital Dayton, Ohio | Amy Jones - (Jonesa11@childrensdayton.org) |
| Emory University Atlanta, Georgia | Ashleigh Streby - (ashleigh.streby@emory.edu) |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | Andrew James - (andrew.james@corewellhealth.org) |
| Indiana University Medical Center Indianapolis, Indiana | Lisa Bendy - (lbendy@iu.edu) |
| Joe DiMaggio Children's Hospital Hollywood, Florida | Norma (Jean) Barton - (nbarton@mhs.net) |
| John Hopkins Hospital Baltimore, Maryland | Jeanne Pinto - (jpinto4@jh.edu) |
| Lenox Hill Hospital Cystic Fibrosis Center New York, New York | Teresa Demarco - (Tdemarco3@northwell.edu) |
| Long Beach Memorial Medical Center Long Beach, California | Marylee Melendrez - (mmelendrez@memorialcare.org) |
| Maine Medical Center Portland, Maine | Harmony Renna - (Harmony.Renna@mainehealth.org) |
| Medical University of South Carolina Charleston, South Carolina | Ashley Warden - (jonesash@musc.edu) |
| Morristown Medical Center Morristown, New Jersey | Debra Connolly - (Debra.Connolly@atlantichealth.org) |
| Nationwide Children's Hospital Columbus, Ohio | Diana Gilmore - (Diana.Gilmore@nationwidechildrens.org) |
| Nemours Children's Clinic Jacksonville, Florida | Jennifer (Jenn) Gafford - (Jennifer.gafford@nemours.org) |
| New York Medical College at Westchester Medical Center Valhalla, New York | Zachary Messer - (Zachary_Messer@nymc.edu) |
| Northwestern University Chicago, Illinois | Rachel Nelson - (rachel.nelson@northwestern.edu) |
| OSF Saint Francis Medical Center Peoria, Illinois | Ashley Scott - (Ashley.Scott@osfhealthcare.org) |
| Oklahoma Cystic Fibrosis Center Oklahoma City, Oklahoma | CF Center Participant Contact - (cfresearchteam@ouhsc.edu) |
| Oregon Health Sciences University Portland, Oregon | Jenna Bucher - (bucherj@ohsu.edu) |
| Providence Medical Group, Cystic Fibrosis Clinic Spokane, Washington | Joan Milton - (joan.milton@providence.org) |
| Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center Cleveland, Ohio | Primary RC & Participant Contact General Contact - (RainbowCFResearch@UHhospitals.org) |
| Riley Hospital for Children Indianapolis, Indiana | Lisa Bendy - (lbendy@iupui.edu) |
| Rutgers - Robert Wood Johnson Medical School New Brunswick, New Jersey | Sheila Redding, Sheila - (sr1238@rwjms.rutgers.edu) |
| SSM Health Cardinal Glennon Children's Hospital St Louis, Missouri | Freda Branch - (freda.branch@health.slu.edu) |
| Saint Luke's Cystic Fibrosis Center of Idaho Boise, Idaho | Lejla Godusevic - (godusevl@slhs.org) |
| Seattle Children's Hospital Seattle, Washington | Sharon McNamara - (sharon.mcnamara@seattlechildrens.org) |
| The Children's Hospital Alabama, University of Alabama at Birmingham Birmingham, Alabama | Heather Hathorne - (hyhathorne@uabmc.edu) |
| Toledo Children's Hospital Toledo, Ohio | Kelly Hoot - (kelly.hoot@promedica.org) |
| Tucson Cystic Fibrosis Center Tucson, Arizona | Elizabeth Ryan - (elizabethryan@email.arizona.edu) |
| University of Calgary Adult Cystic Fibrosis Clinic (Calgary, AB) Calgary, Alberta | Clare Smith - (Clare.smith@albertahealthservices.ca) |
| University of California San Diego La Jolla, California | Jenna Mielke, - (jmielke@health.ucsd.edu) |
| University of California at Davis Medical Center Sacramento, California | Daniel Diaz-Vigil - (ddiazvigil@ucdavis.edu) |
| University of Cincinnati Medical Center Cincinnati, Ohio | Nicole Hummel - (Nicole.Hummel@UCHealth.com) |
| University of Florida Gainesville, Florida | Melissa Lingis - (melissa.lingis@peds.ufl.edu) |
| University of Iowa Iowa City, Iowa | Mary Teresi - (mary-teresi@uiowa.edu) |
| University of Kansas Medical Center Kansas City, Kansas | Lawrence Scott - (lscott2@kumc.edu) |
| University of Louisville Louisville, Kentucky | Melissa Thomas - (mcthom12@louisville.edu) |
| University of Massachusetts Memorial Health Care Worcester, Massachusetts | Jaclyn Longtine - (Jaclyn.Longtine@umassmed.edu) |
| University of Miami Miami, Florida | Ylber Whitaker - (yiw2@miami.edu) |
| University of Michigan, Michigan Medicine Ann Arbor, Michigan | Dawn Kruse - (dmkruse@med.umich.edu) |
| University of Pennsylvania Philadelphia, Pennsylvania | Melissa Molter - (melissa.molter@pennmedicine.upenn.edu) |
| University of Texas Southwestern Dallas, Texas | Ashley Keller - (Ashley.Keller@UTSouthwestern.edu) |
| University of Texas Southwestern / Children's Health Dallas, Texas | Mary Klosterman - (Mary.Klosterman@UTSouthwestern.edu) |
| University of Washington Medical Center Seattle, Washington | Lauren Bartlett - (lrejman@uw.edu) |
| University of Wisconsin Madison, Wisconsin | Melanie Nelson - (mnelson@pediatrics.wisc.edu) |
| Vanderbilt Children's Hospital Nashville, Tennessee | Brijesh Patel - (brijesh.patel@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | Akilah Pierre-Louis - (akilah.pierrelouis1@vcuhealth.org) |
| Washington University School of Medicine St Louis, Missouri | Irma Bauer - (irmabauer@wustl.edu) |
| West Virginia University - Morgantown Morgantown, West Virginia | Tammy Clark - (tclark@hsc.wvu.edu) |
Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer (STRIKE)
Aishwarya Vijendran - guprotocols@alliancenctn.org
NCT06661720
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Inclusion Criteria:
* • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)
* Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted
* Intermediate-high risk RCC:
* pT2 grade 4 or sarcomatoid features, N0M0
* pT3 any grade N0, M0
* High-risk RCC
* pT4, any grade, N0, M0
* pT, any stage., any grade, N+, M0
* cM1 no evidence of disease (NED) RCC
* Participants who have had resection of primary tumor (radical or partical nephrectomy) and resection or definitive radiation or ablation of solid, isolated, soft tissue metastases (excluding brain and bone lesions) at the time of primary tumor removal (synchronous) or ≤1 year from primary tumor removal (metachronous)
* Surgery (radical or partial nephrectomy or metastasectomy or ablation) \> 4 weeks but =\< 16 weeks prior to study registration with no ongoing complications from surgery
* No evidence of disease at time of randomization as assessed by investigator by either CT or MRI scan of the brain and chest, abdomen and pelvis
* No prior systemic treatment for RCC
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (or Karnofsky \>= 60%)
* Absolute neutrophil count (ANC) \>= 1,000/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 8 g/dL
* Total bilirubin =\< 3 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x upper limit of normal (ULN)
* Calculated (calc.) creatinine clearance \>= 30 mL/min (using Cockcroft Gault equation or the estimated glomerular filtration rate from the modification of diet in renal disease trial)
* Urine protein =\< 1+ on urine analysis (UA) or urine protein creatinine ration (UPCR) \< 2mg/mg
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test is required =\< 14 days prior to registration
* HIV status: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Hepatitis
* Hepatitis B: 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 resolved HBV infection, defined as positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antigen (HbsAg), are eligible
* Hepatitis C: 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
* Cardiac Disease: 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 IIB or better
* No history of myocarditis
* No history of clinically significant pneumonitis
* No uncontrolled hypertension (systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 90 mm Hg) documented on 2 consecutive measurements taken at least 2 hours apart
* No serious non-healing wound, ulcer or bone fracture within 28 days prior to registration
* No serious/active infection requiring parenteral antibiotics
* No moderate or severe hepatic impairment (child-Pugh B or C)
* No significant bleeding disorders within 1 month prior to registration, for example:
* Hematemesis, hematochezia or other gastrointestinal bleeding grade 3 or higher
* Hemoptysis of pulmonary bleeding grade 3 or higher
* Hematuria or other genitourinary bleeding grade 3 or higher
* No history of allogeneic organ transplantation
* No history of allergy of hypersensitivity to study drugs or components
* No condition requiring systemic treatment with either corticosteroid (\> 10 mg daily or prednisone equivalent) within 14 days of treatment initiation or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement doses ≤10 mg daily prednisone equivalent are permitted in absence of active autoimmune disease
* No active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition associated with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to registration
* 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
* No patients with a history of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids \> 10 mg/day, or immunosuppressive drugs) with the following exceptions:
* Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* Brief (\<7 days) use of systemic corticosteroids is allowed when use is considered standard of care
* Patients with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded
* Patients requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded
* Patients with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment BIOLOGICAL: Pembrolizumab, DRUG: Tivozanib, PROCEDURE: Biospecimen Collection, PROCEDURE: MRI, PROCEDURE: Computed Tomography, PROCEDURE: Biopsy, OTHER: Questionnaire Administration
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma (RCC), Stage II Renal Pelvis Cancer AJCC v8, Stage III Renal Pelvis Cancer AJCC v8
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Study Locations
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| 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 | |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| 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 Health Louisville Louisville, Kentucky | Site Public Contact - (Cbcresearch@bhsi.com) |
| 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) |
| 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) |
| 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) |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Richmond Community Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.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) |
| California Pacific Medical Center-Pacific Campus San Francisco, California | Site Public Contact - (clinicalresearch@sutterhealth.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 Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| 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) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| 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 Bay Torrance, California | |
| City of Hope Upland Upland, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope at Irvine Lennar Irvine, California | |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Corewell Health Grand Rapids Hospitals - Butterworth 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) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana Farber-Merrimack Valley Methuen, Massachusetts | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dana-Farber Cancer Institute at Foxborough Foxborough, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth, Massachusetts | |
| Dartmouth Cancer Center - North Saint Johnsbury, Vermont | |
| 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) |
| Divine Providence Hospital Williamsport, Pennsylvania | Site Public Contact - (protocols@AllianceNCTN.org) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Duke Cancer Center Cary Cary, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke Cancer Center Raleigh Raleigh, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.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 | |
| 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) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| 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 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) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| George Washington University Medical Center Washington D.C., District of Columbia | |
| Glens Falls Hospital Glens Falls, New York | |
| Grady Health System Atlanta, Georgia | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hartford HealthCare - Saint Vincent's Medical Center Bridgeport, Connecticut | |
| Hartford Healthcare - Fairfield Fairfield, Connecticut | Site Public Contact - (CancerResearchSupport@hhchealth.org) |
| Hartford Hospital Hartford, Connecticut | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hematology Oncology Associates of CNY at Camillus Camillus, New York | |
| Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York | |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Houston Methodist Cypress Hospital Cypress, Texas | Site Public Contact - (irb@houstonmethodist.org) |
| Houston Methodist Hospital Houston, Texas | |
| Houston Methodist Saint John Hospital Nassau Bay, Texas | Site Public Contact - (protocols@AllianceNCTN.org) |
| Houston Methodist San Jacinto Hospital Baytown, Texas | Site Public Contact - (protocols@AllianceNCTN.org) |
| Houston Methodist Sugar Land Hospital Sugar Land, Texas | |
| Houston Methodist The Woodlands Hospital The Woodlands, Texas | Site Public Contact - (hmthewoodlands@houstonmethodist.org) |
| Houston Methodist West Hospital Houston, Texas | |
| IU Health North Hospital Carmel, Indiana | Site Public Contact - (iutrials@iu.edu) |
| IU Health West Hospital Avon, Indiana | Site Public Contact - (iutrials@iu.edu) |
| 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) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | |
| 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) |
| Kettering Medical Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.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) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lahey Hospital and Medical Center Burlington, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| Lahey Medical Center-Peabody Peabody, Massachusetts | Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org) |
| 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) |
| Mary Greeley Medical Center Ames, Iowa | |
| 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) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital North Colorado Springs, Colorado | |
| 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 Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Methodist Willowbrook Hospital Houston, Texas | Site Public Contact - (protocols@AllianceNCTN.org) |
| Miami Cancer Institute Miami, Florida | |
| Midstate Medical Center Meriden, Connecticut | |
| Mills Health Center San Mateo, 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) |
| 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-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Chelsea New York, New York | |
| Mount Sinai Hospital New York, New York | |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas | Site Public Contact - (Emily.Carvell@bmhcc.org) |
| 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 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) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Overlook Hospital Summit, New Jersey | |
| Palo Alto Medical Foundation Health Care Palo Alto, 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 | |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| 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) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Robert Wood Johnson University Hospital Somerset Somerville, New Jersey | Site Public Contact - (Siby.Varughese@rwjbh.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rush MD Anderson Cancer Center Chicago, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| 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 | |
| Rutgers New Jersey Medical School Newark, New Jersey | |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| 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 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 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 | |
| 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) |
| Sidney and Lois Eskenazi Hospital Indianapolis, Indiana | Site Public Contact - (iutrials@iu.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 | |
| 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 | |
| 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) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stamford Hospital/Bennett Cancer Center Stamford, Connecticut | |
| Sutter Auburn Faith Hospital Auburn, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Sutter Medical Center Sacramento Sacramento, 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) |
| The Cancer Institute of New Jersey Hamilton Hamilton, New Jersey | |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | Site Public Contact - (Gina.Cravey@bsahs.org) |
| The Hospital of Central Connecticut New Britain, Connecticut | |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Tidelands Georgetown Memorial Hospital Georgetown, South Carolina | Site Public Contact - (broe@tidelandshealth.org) |
| 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) |
| 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 Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.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 Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| 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) |
| UCHealth - Cherry Creek Denver, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado | |
| UCHealth Lone Tree Health Center Lone Tree, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | Site Public Contact - (ucstudy@uci.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 UH Avon Health Center Avon, Ohio | |
| 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) |
| 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 Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Butler Health System Butler, Pennsylvania | Site Public Contact - (haneydl@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 | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| USC Norris Oncology/Hematology-Newport Beach Newport Beach, California | |
| 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) |
| 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) |
| United Hospital Center Bridgeport, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| 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 Illinois Chicago, Illinois | |
| 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 Mississippi Medical Center Jackson, Mississippi | |
| 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 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) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| 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) |
| WVUH-Berkely Medical Center Martinsburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut |
A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD (FORTITUDE-3)
Avidity Biosciences, Inc. - medinfo@aviditybio.com
NCT07038200
Show full eligibility criteria
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Inclusion Criteria:
* Clinical and genetic diagnosis of FSHD1 or FSHD2
* Ability to walk independently at pre-specified walking speed (orthoses and ankle braces allowed) for at least 10 meters at screening
* Adequate muscle strength based on QMT composite score
Exclusion Criteria:
* Breastfeeding, pregnancy, or intent to become pregnant during the study
* Unwilling or unable to comply with contraceptive requirements
* Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study
* Blood Pressure \> 140/90 mmHg at Screening
* Treatment with another investigational drug or biological agent within 1 month of Screening or 5 half-lives of the drug, whichever is longer
* Treatment with an oligonucleotide within 9 months of Screening DRUG: AOC-1020, DRUG: Placebo
Facioscapulohumeral Muscular Dystrophy, FSHD, FSHD - Facioscapulohumeral Muscular Dystrophy, FSHD1, FSHD2, Fascioscapulohumeral Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy Type 1, Fascioscapulohumeral Muscular Dystrophy Type 2, Facioscapulohumeral Muscular Dystrophy 1, Facioscapulohumeral Dystrophy, Facio-Scapulo-Humeral Dystrophy, Facioscapulohumeral Muscular Dystrophy 2, Facioscapulohumeral Muscular Dystrophy Type 1 (FSHD1), FSH Muscular Dystrophy, Landouzy Dejerine Dystrophy, Landouzy-Dejerine Muscular Dystrophy, Landouzy-Dejerine Syndrome
Avidity, Avidity Biosciences, del-brax, del brax, delbrax, AOC1020, AOC 1020, delpacibart braxlosiran, FORTITUDE-3, FORTITUDE Phase 3, FORTITUDE, FORTITUDE 3
I'm interested
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Show 14 locations
Study Locations
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| Location | Contacts |
|---|---|
| Duke University Durham, North Carolina | |
| Kansas University Medical Center Kansas City, Kansas | |
| Kennedy Krieger Institute Baltimore, Maryland | |
| Ohio State University Colombus, Ohio | |
| Stanford University Stanford, California | |
| University of California Irvine Orange, California | |
| University of Colorado Aurora, Colorado | |
| University of Florida Gainesville, Florida | |
| University of Iowa Iowa City, Iowa | |
| University of Massachusetts Worcester, Massachusetts | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of Rochester Medical Center Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | |
| Virginia Commonwealth University Richmond, Virginia |
Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
Joyce Ruddley, RN - study4u@vcu.edu
NCT06981195
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Be 18 + years-of-age
• Meet current DSM-5 criteria for opioid use disorder (OUD) with at least moderate severity
• Receiving outpatient treatment for OUD with sublingual buprenorphine film/tablets ranging 8mg to 24mg or with extended-release injectable buprenorphine
• Stabilized on current buprenorphine dosage for at least 4 weeks without intention for dose change within next 3 months.
• Screening urine toxicology positive for buprenorphine and an appropriate norbuprenorphine level as determined by a study clinician
• A screening urine toxicology negative for non-prescribed substances (except cannabinoids) with a negative breath (or oral fluid) alcohol screen
• Screen positive for chronic insomnia on the Insomnia Symptom Questionnaire (ISQ)
• Have an Insomnia Severity Index score at screening and baseline of 13 or higher
• Have no clinically significant medical or psychiatric disorder or condition, based on physical exam and medical history performed by study clinician, that in the judgement of the investigator would prevent participation or heighten safety risks
• Understand the study procedures and provide written informed consent in English language
• Access to necessary resources for completing virtual surveys and monitoring (i.e., computer or smartphone, internet or cell service)
Exclusion Criteria:
• Current diagnosis of sleep-related breathing disorder, narcolepsy, somnambulism, or sleep paralysis
• A positive screen for sleep apnea by the following: Sleep Disorders Screening Battery (STOP-BAG \>5) OR home sleep apnea test using WatchPAT with Apnea Hypopnea Index (AHI) with 3% drop in oxygen saturation \> 10 OR \>50% of respiratory events being central if AHI is between 5-10 OR Oxygen Desaturation \< 88% for \> 10 minutes, OR oxygen desaturation index (ODI) using 3% drop in oxygen saturation \> 10
• Currently receiving treatment for insomnia (behavioral or pharmacologic)
• Currently taking a medication to treat a sleep-related condition (e.g., zolpidem) or unable to discontinue over-the-counter drug or supplement used to treat sleep-related condition
• Currently taking benzodiazepines or other CNS active medications that may increase risk to the participant, per PI discretion (e.g., opioids other than buprenorphine, antipsychotics)
• Current DSM-5 diagnosis (any severity) of alcohol or drug use disorder (e.g., benzodiazepine, stimulant) with non-prescribed substance use within last 3 months; nicotine use disorder is not considered exclusionary
• Cannabis use \> 3 days/week
• Uncontrolled serious psychiatric disorder that would make study participation unsafe (such as Bipolar I Disorder, ADHD, Schizophrenia, schizoaffective disorders, major depressive disorder with psychotic features, or a neurological disorder).
• Uncontrolled neurological, cardiovascular, or pulmonary medical condition such as seizure disorder, recent myocardial infarction, stroke, hospitalization for chronic obstructive pulmonary disease
• Baseline ECG with clinically significant abnormal conduction or with QTc of greater than 450ms
• Significant current suicidal or homicidal ideation (C-SSRS "yes" answers on questions 4 or 5) or a history of suicide attempt within the past 6 months
• Any of the following lab abnormalities: ALT/AST 2 or more times the upper limit of normal, Total bilirubin 2 or more times the upper limit of normal, Creatinine 1.5 or more times the upper limit of normal
• Pregnant or breastfeeding; Females who are having sex that includes penile penetration must be non-pregnant, non-lactating, and either be of non-childbearing potential (e.g., sterilized via hysterectomy, bilateral tubal ligation, or bilateral oophorectomy, or at least 1 year post-menopausal) or of childbearing potential, and agree to use an acceptable form of contraception (e.g., IUD, hormonal implant, hormonal patch/ring/pill, condoms (male or female), etc.)
• Currently taking prescription or over-the counter drugs or dietary supplements known to significantly inhibit CYP3A4 (such as clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir); or CYP3A4 inducers (such as phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids)
• Currently taking lemborexant or any previous medically adverse reaction to lemborexant or other dual orexin receptor antagonists
• Currently incarcerated or pending incarceration
DRUG: Placebo, DRUG: Lemborexant 10 MG
Opioid Use Disorder, Opioid Use, Insomnia, Orexin Antagonist
buprenorphine, lemborexant
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| Location | Contacts |
|---|---|
| VCU Institute for Drug and Alcohol Studies Richmond, Virginia |
TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age (TIDES 2)
Beth A Smith, MD - balucas@buffalo.edu
NCT07048574
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Inclusion Criteria:
• Child with a diagnosis of Cystic fibrosis (CF) actively followed by the CF care team at a participating site
• Child is age 18 months thru 11 years
• English and/or Spanish speaking
• Parent/legal guardian willing and able to give informed consent, and for minor participants ages 7 thru 11 years able to give assent.
Exclusion Criteria:
* Unable or unwilling to participate in study procedures, or at Site PI discretion. Cystic Fibrosis (CF)
Cystic Fibrosis, Children, Mental health screening, Depression, Anxiety, CFTR modulators, Neuropsychiatric adverse events
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| Location | Contacts |
|---|---|
| Brown University Health Providence, Rhode Island | |
| Children's Hospital Colorado Aurora, Colorado | Emily Muther, PhD - (Emily.Muther@childrenscolorado.org) |
| Children's Hospital of Orange County Orange, California | Adrianne Alpern, PhD - (aalpern@choc.org) |
| Children's Hospital of Richmond at Virginia Commonwealth University Richmond, Virginia | Michael S Schechter, MD, MPH - (michael.schechter@vcuhealth.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Stephanie Filigno, PhD - (stephanie.filigno@cchmc.org) |
| Indiana University Indianapolis, Indiana | Emma M Tillman, PhD, PharmD - (emtillma@iu.edu) |
| Joe DiMaggio Hollywood, Florida | Alexandra L Quittner, PhD - (aquittner@mhs.net) |
| Massachusetts General Hospital Boston, Massachusetts | Anna M Georgiopoulos, MD - (AGEORGIOPOULOS@mgh.harvard.edu) |
| Nemours Foundation Orlando, Florida | David Fedele, PhD - (David.Fedele@nemours.org) |
| Seattle Children's Hospital Seattle, Washington | Freda Liu, PhD - (freda.liu@seattlechildrens.org) |
| UT Southwestern Dallas, Texas | Meghna Sathe, MD - (meghna.sathe@utsouthwestern.edu) |
| University at Buffalo Buffalo, New York | Danielle M Goetz, MD - (dgoetz@upa.chob.edu) |
| University of North Carolina School of Medicine Chapel Hill, North Carolina | Mary Beth Prieur, PhD - (mary_grimley@med.unc.edu) |
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial
ctrrecruit@vcu.edu
NCT06770582
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Inclusion Criteria:
* Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without radiographic evidence of regional nodal disease or metastatic disease (N0, M0) on CT, MRI, or positron emission tomography (PET)/CT scan who would otherwise be treated with cystectomy off-trial. Patients should have cystectomy recommended disease but do not need to be medically operable for a cystectomy to be eligible for the trial.
* NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible
* High grade T1 disease history that must meet at least ONE of the three criteria below:
* Histologically confirmed recurrence with high-grade T1 urothelial carcinoma (+/- focal carcinoma in situ \[CIS\]) in the bladder following initial transurethral resection of bladder tumor (TURBT) and at least one induction course of intravesical therapy. Adequate induction course is defined as ≥ 5 doses of intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy when BCG is not available.
* T1 with pathologic high-risk features (lymphovascular invasion \[LVI\] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features) post initial TURBT. (No prior intravesical therapy required)
* Persistent high-grade T1 urothelial carcinoma at repeat TURBT (+/- focal CIS) in the bladder. (No prior intravesical therapy required)
* Restaging TURBT must be performed and must meet ALL of the following criteria below:
* If there is absence of muscularis propria in the initial TURBT, there must be uninvolved muscularis propria in the restaging TURBT.
* All grossly visible papillary tumors must be removed
* Note: If the restaging TURBT is performed outside of the enrolling institution, an office cystoscopy should be performed by a Urologist who will be following the patient as part of the clinical trial
* No pure squamous cell carcinoma or adenocarcinoma of the bladder
* No neuroendocrine (small or large cell) features
* No diffuse carcinoma in situ determined on cystoscopy and biopsy (i.e. extensive carcinoma in situ that is not just tumor-associated CIS in the opinion of the site investigator)
* No prostatic urethral involvement
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* 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), tubal ligation or who is not postmenopausal
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
* Platelets ≥ 100,000 cells/mm\^3
* Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 9 g/dl is acceptable)
* Adequate renal function defined as creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula, ≤ 1.5 × upper limit of normal (ULN) or creatinine levels \> 1.5 × institutional ULN
* Total bilirubin ≤ institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN
* All adverse events of their most recent therapy/intervention must have resolved to \< grade 3 or returned to baseline prior to registration
* No history of pelvic radiation therapy
* No prior systemic chemotherapy or immunotherapy for urothelial carcinoma. Prior treatment with local intravesical therapy including BCG or chemotherapy is allowed
* No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation
* No live vaccine administered within 30 days of registration. All non live vaccines (including the coronavirus disease \[COVID\] vaccine) are allowed at any time during the study. Timing should minimize confusion with drug-related toxicities where possible
* Patients must have recovered from acute cardiac illness
* New York Heart Association Functional Classification II 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 IV antibiotics
* No active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
* No history of idiopathic pulmonary fibrosis, organizing pneumonia, (non-infectious) pneumonitis that required steroids or current pneumonitis
* No history of allogeneic bone marrow transplant or prior solid organ transplant
* No active tuberculosis
* No evidence of hydronephrosis
* No history of upper tract urothelial carcinoma within 24 months of registration
* No patients with a prior diagnosis of prostate cancer who have not received definitive treatment for their prostate cancer (e.g. on active surveillance)
* 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
* No glucocorticoids except physiologic doses are allowed. The use of doses of corticosteroids (defined as 10 mg prednisone or equivalent) is acceptable
* No history of allergic reaction to the drug excipients PROCEDURE: Biospecimen Collection, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Fluorouracil, DRUG: Gemcitabine, PROCEDURE: Magnetic Resonance Imaging, DRUG: Mitomycin, BIOLOGICAL: Pembrolizumab, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy
Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage I Bladder Cancer AJCC v8
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| Location | Contacts |
|---|---|
| AIS Cancer Center at San Joaquin Community Hospital Bakersfield, California | |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia | |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| 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 Proton Therapy Center Atlanta, Georgia | Site Public Contact - (allyson.anderson@emory.edu) |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| 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 Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| 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) |
| 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) |
| Grady Health System Atlanta, Georgia | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Los Angeles General Medical Center Los Angeles, California | Site Public Contact - (uscnorrisinfo@med.usc.edu) |
| Louisiana Hematology Oncology Associates LLC Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Mary Bird Perkins Cancer Center Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Mary Bird Perkins Cancer Center - Gonzales Gonzales, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Mary Bird Perkins Cancer Center - Metairie Metairie, Louisiana | |
| Mary Greeley Medical Center Ames, Iowa | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.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-West Lakes Clive, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.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) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Mount Sinai Medical Center Miami Beach, Florida | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Rush MD Anderson Cancer Center Chicago, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@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) |
| Shaw Cancer Center Edwards, Colorado | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| 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) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UPMC Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania | |
| UPMC Cancer Center-Washington Washington, Pennsylvania | Site Public Contact - (Roster@nrgoncology.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 Washington Hospital Radiation Oncology Washington, Pennsylvania | Site Public Contact - (cancer@washingtonhospital.org) |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| UPMC-Shadyside Hospital Pittsburgh, Pennsylvania | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| 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 Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| 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 | |
| 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) |
PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients (MAGProm)
Vicky Crawford - vcrawford@endomag.com
NCT06610539
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Inclusion Criteria:
* Patient is willing and able to give informed consent for participation in the study
* Patient is aged 18 years or older at the time of consent
* Patients undergoing planned breast conserving surgery (for example, lumpectomy or partial mastectomy) and SLNB with Magtrace
Exclusion Criteria:
* The patient is pregnant or lactating
* The patient has had prior breast radiation to the ipsilateral breast
* The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
* The patient has recevied a Feraheme (ferumoxytol) injection within the past 6 months
* The patient has intolerance or hypersensitivity to iron or dextran compounds or to Magtrace
* The patient has iron overload disease
* The patient has discoloration on the breast (such as tattoo, birthmark, tanning, rash etc.), that in the Investigator's opinion, could impact the clinical trial results, specifically the assessment of any skin discoloration, or plans to have a tattoo on the breast post-operatively. Breast Cancer
Magtrace, Sentinel Lymph Node Biopsy
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| Location | Contacts |
|---|---|
| VCU Massey Comprehensive Cancer Center Richmond, Virginia |
A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
ctrrecruit@vcu.edu
NCT06124157
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Inclusion Criteria:
* Patients must be \> 365 days and \< 18 years (for AIEOP-BFM), \> 365 days and \< 22 years (for Children's Oncology Group \[COG\]) and \> 365 days and \< 46 years (for ALLTogether sites) at the time of enrollment
* Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB
* Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during Induction therapy. ABL-class Ph-like B-ALL gene rearrangements should be documented by a clinically-validated assay and enrolled on study by day 1 of Blinatumomab Block 1. Accepted methods of detection include fluorescence in situ hybridization (FISH) using break-apart of colocalization signal probes, singleplex or multiplex reverse-transcription polymerase chain reaction (RT-PCR), whole-transcriptome or panel-based ribonucleic acid (RNA) sequencing (e.g., Hematologic Cancer Fusion Analysis, TruSight RNA Pan-Cancer Panel or equivalent). Confirmation of 5' fusion partner genes is not required for study enrollment
* Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and/or other standard cytotoxic chemotherapy
* Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine
* Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)
* Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of ≤ 2 or Karnofsky and Lansky performance scores ≥ 50%. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age
* For pediatric patients (age 1-17 years): a glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\^2, as determined by one of the following methods (must be performed within 7 days prior to enrollment unless otherwise indicated):
* Estimated GFR (eGFR) ≥ 50 mL/min/1.73 m2
* Measured GFR ≥ 50 mL/min/1.73 m\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard
* For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on body weight
* Direct bilirubin \< 2.0 mg/dL (34.2 micromoles/L) (must be performed within 7 days prior to enrollment unless otherwise indicated)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10 x upper limit of normal (ULN) (must be performed within 7 days prior to enrollment unless otherwise indicated)
* \* Shortening fraction of ≥ 27% by echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \[repeat if necessary\]) OR
* Left Ventricular Ejection fraction of ≥ 50% by radionuclide angiogram or echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \[repeat if necessary\]) AND
* Corrected QT Interval, QTc \< 480mSec (must be obtained within 21 days prior to enrollment and start of protocol therapy \[repeat if necessary\])
* Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis before study enrollment
Exclusion Criteria:
* Known history of chronic myeloid leukemia (CML)
* ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
* ALL developing after a previous cancer treated with cytotoxic chemotherapy
* Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
* Down syndrome (trisomy 21)
* Pregnancy and breast feeding
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A negative pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment
* Lactating females who plan to breastfeed their infants
* Sexually active male and female patients of reproductive potential who have not agreed to use an effective contraception method for the duration of treatment according to protocol
* NOTE: Patients who could become pregnant or could father a child must use effective contraception during protocol treatment and for 30 days after the last dose of dasatinib or 14 days after the last dose of imatinib dose or per institutional standard of care for multiagent chemotherapy, whichever is longer
* Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib
* Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block
* Patients with known Charcot-Marie-Tooth disease
* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with central nervous system (CNS) involvement
* Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible. Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved
* HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment
* 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 PROCEDURE: Biospecimen Collection, BIOLOGICAL: Blinatumomab, PROCEDURE: Bone Marrow Biopsy, DRUG: Calaspargase Pegol, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Dasatinib, DRUG: Daunorubicin, DRUG: Doxorubicin, PROCEDURE: Echocardiography Test, DRUG: Imatinib, DRUG: Leucovorin, DRUG: Mercaptopurine, DRUG: Methotrexate, PROCEDURE: Multigated Acquisition Scan, DRUG: Pegaspargase, DRUG: Prednisolone, DRUG: Prednisone, RADIATION: Radiation Therapy, DRUG: Thioguanine, DRUG: Vincristine
B Acute Lymphoblastic Leukemia
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| Location | Contacts |
|---|---|
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Atrium Health Navicent Macon, Georgia | Site Public Contact - (andrew.weatherall@atriumhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.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) |
| 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 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 and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| 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 Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.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) |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| 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) |
| Duke University Medical Center Durham, North Carolina | |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| 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 | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Morristown Medical Center Morristown, New Jersey | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.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) |
| New York Medical College Valhalla, New York | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Primary Children's Hospital Salt Lake City, Utah | |
| 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 Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.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 Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Pediatric Hospital San Juan, | |
| 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 Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.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 - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| 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) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma
ctrrecruit@vcu.edu
NCT05304585
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Inclusion Criteria:
* All patients must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular Characterization Initiative (Part A) prior to enrollment and treatment on ARST2032 (this trial).
* Patients must be =\< 21 years at the time of enrollment.
* Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable). RMS types included under ERMS include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Enrollment in APEC14B1 is required for all patients.
* All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remains unchanged regardless of any second-look operation that may be performed.
* Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease.
* Patients will be eligible for the low-risk stratum (Regimen VAC/VA) if they have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III (orbit only) disease.
* Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling (SIRLNS) is required for all patients \>= 10 years of age with paratesticular tumors who do not have gross nodal involvement on imaging.
* Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors.
* Clinically or radiographically enlarged nodes must be sampled for histologic evaluation.
* Patients must have a Lansky (for patients =\< 16 years of age) or Karnofsky (for patients \> 16 years of age) performance status score of \>= 50. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing performance score.
* Peripheral absolute neutrophil count (ANC) \>= 750/uL (within 7 days prior to enrollment).
* Platelet count \>= 75,000/uL (transfusion independent) (within 7 days prior to enrollment).
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine (within 7 days prior to enrollment) based on age/gender as follows:
* Age: 1 month to \< 6 months; Maximum serum creatinine (mg/dL): 0.4 (male) : 0.4 (female)
* Age: 6 months to \< 1 year; Maximum serum creatinine (mg/dL): 0.5 (male) : 0.5 (female)
* Age: 1 to \< 2 years; Maximum serum creatinine (mg/dL): 0.6 (male) : 0.6 (female)
* Age: 2 to \< 6 years; Maximum serum creatinine (mg/dL): 0.8 (male) : 0.8 (female)
* Age: 6 to \< 10 years; Maximum serum creatinine (mg/dL): 1 (male) : 1 (female)
* Age: 10 to \< 13 years; Maximum serum creatinine (mg/dL): 1.2 (male) : 1.2 (female)
* Age: 13 to \< 16 years; Maximum serum creatinine (mg/dL): 1.5 (male) : 1.4 (female)
* Age \>= 16 years; Maximum serum creatinine (mg/dL): 1.7 (male) : 1.4 (female)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and
* If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \< 3 x ULN for age.
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L.
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L
* If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \< 3 x ULN for age
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
* 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 who have received prior chemotherapy and/or radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted.
* Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.
* Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment.
* Patients unable to undergo radiation therapy, if necessary, as specified in the protocol.
* Evidence of uncontrolled infection.
* 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: Biopsy Procedure, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, BIOLOGICAL: Dactinomycin, PROCEDURE: Magnetic Resonance Elastography, PROCEDURE: Positron Emission Tomography, RADIATION: Radiation Therapy, DRUG: Vincristine
Embryonal Rhabdomyosarcoma, Fusion-Negative Alveolar Rhabdomyosarcoma, Spindle Cell/Sclerosing Rhabdomyosarcoma
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Show 177 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Atrium Health Navicent Macon, Georgia | Site Public Contact - (andrew.weatherall@atriumhealth.org) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| 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) |
| 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) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| 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 | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| 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 Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| 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) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| 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) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| 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) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| 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 | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| 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) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center -San Diego San Diego, California | |
| 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 | |
| Northwestern Medicine Central DuPage Hospital Winfield, Illinois | Site Public Contact - (Claudine.Gamster@CadenceHealth.org) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Primary Children's Hospital Salt Lake City, Utah | |
| 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 | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| 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 | |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| 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) |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Starship Children's Hospital Grafton, Auckland | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sydney Children's Hospital Randwick, New South Wales | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| 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) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| 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 Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| 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 Rochester Rochester, New York | |
| 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) |
| Wesley Medical Center Wichita, Kansas | Site Public Contact - (WesleyResearch@wesleymc.com) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Perf-Fix Study for Chronic Tympanic Membrane Repair
Nicole Orth - north@namsa.com
NCT06083181
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Inclusion Criteria:
* Willing and able to provide informed consent, legally authorized representative (LAR) consent, or LAR consent and assent when age appropriate
* Females and males at least 5 years old
* Perforation involves \>25% of the tympanic membrane
* Perforation has not spontaneously closed after 4 weeks of watchful waiting
* Perforation is not actively healing
* Perforation can be visualized by an endoscope or microscope
* Ear wax does not occlude the perforation
Exclusion Criteria:
* Perforation is marginal (a perforation that has an area with no tympanic membrane between the perforation and the bony canal)
* Active otitis media, with or without effusion
* Otorrhea from the middle ear for more than 3 months
* History of cleft palate
* Receiving radiation therapy or taking corticosteroids, immunosuppressive agents, or chemotherapy
* Currently taking systemic antibiotics, antibiotic ear drops, and/or steroid ear drops
* Current bacterial or viral infection
* Fever (Temperature \>100°F) at time of index procedure
* Diagnosed with cholesteatoma mass in the tympanic cavity
* Known history of malignant ear canal tumors within 3 years of screening for eligibility
* Abrasions/lacerations to the external auditory canal
* Significant medical condition that could prevent full participation in the procedures required for the study
* Investigator feels the subject will be unable to cooperate with the application procedure
* Parent/LAR feels the subject will be unable to cooperate with the application procedure
* Allergy to shellfish
* Known to be or could be pregnant
* Adults lacking capacity to consent DEVICE: Perf-Fix Otologic Gel Patch
Tympanic Membrane Perforation
tympanic membrane, eardrum, pediatric, tympanoplasty, myringoplasty
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Show 7 locations
Study Locations
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| Location | Contacts |
|---|---|
| Advanced ENT & Allergy Louisville, Kentucky | Rhonda Dase - (rdase@advancedentandallergy.com) |
| Carolina Ear & Hearing Clinic Raleigh, North Carolina | Courtney Gray - (execadmin@carolinaear.us) |
| Eastern Virginia Medical School Norfolk, Virginia | Laura Stone - (stonelj@evms.edu) |
| House Institute Los Angeles, California | Sean Lang - (slang@hifla.org) |
| Mass Eye and Ear Boston, Massachusetts | Michael Cheung - (MCHEUNG0@MEEI.HARVARD.EDU) |
| South Louisiana Ear, Nose, and Throat Mandeville, Louisiana | Ashley Allelo - (aallelo@southlouisianamd.com) |
| Virginia Commonwealth University Richmond, Virginia | Dmytro Nerobeiev - (Dmytro.Nerobeiev@vcuhealth.org) |
Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms
Brett Brooks - bret.brooks@vcuhealth.org
NCT07071350
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Inclusion Criteria:
* age 18 or older
* History of military service
* Self-Reported hx of 1 or more mild TBI
* Most recent TBI more than 1 year ago
* Significant Persistent Post-Concussion Symptom burden (Neurobehavioral Symptom Inventory \[NSI\] total score greater than or equal to 20).
* Current Sleep Difficulties
* Fluent English
* Able to provide Informed Consent
Exclusion Criteria:
* Any TBI with severity greater than mild (i.e., Moderate or Severe TBI defined as initial injury loss of consciousness (LOC) duration \>30 minutes, posttraumatic amnesia (PTA) duration \>24 hours, or traumatic hemorrhage on head computerized tomography (CT) and determined by the study investigator based on information gathered during administration of the study's validated TBI structured interview instrument.
* Conditions or medications that can affect HRV measurement (pacemaker or an implant that stimulates your heart (e.g., cardioverter-defibrillator or ICD); heart transplant or heart surgery within the last year, including bypass or other surgery, but not including a stent)
* Hx of stroke
* Mental conditions that may impede adherence (e.g., dementia, psychotic disorder, panic disorder) OTHER: HRV Coherence Ratio, BEHAVIORAL: NSI, BEHAVIORAL: Pittsburgh Sleep Quality Index (PSQI), BEHAVIORAL: Quantitative Sleep Measures, BEHAVIORAL: Patient Global Impression of Change (PGIC), BEHAVIORAL: Cognitive Performance/NIH Toolbox Cognitive Battery, OTHER: Pain Interference/TBI-QoL Pain Interference Short-Form, BEHAVIORAL: Patient Health Questionnaire-9 (PHQ-9), BEHAVIORAL: PTSD Checklist for DSM-5 (PCL-5), OTHER: HRV Biofeedback (HRV-B), OTHER: Psychoeducational (Edu) Comparator Intervention
Autonomic Nervous System Disease, Concussive Injury, Mild Traumatic Brain Injury, Post Traumatic Stress Disorder, Persistent Post Concussion Syndrome
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Bret Brooks - (brooksbm2@vcu.edu) Jennifer Weggen - (weggenj@vcu.edu) |
A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy (OrigAMI-3)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT06750094
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Inclusion Criteria:
* Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
* Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing
* Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
* Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
* Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
* Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy
Exclusion Criteria:
* Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
* Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI
* Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
* Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments
* Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
* Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET) BIOLOGICAL: Amivantamab, BIOLOGICAL: Cetuximab, BIOLOGICAL: Bevacizumab, DRUG: 5-fluorouracil, DRUG: Leucovorin calcium/Levoleucovorin, DRUG: Irinotecan
Colorectal Neoplasms
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Show 226 locations
Study Locations
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| Location | Contacts |
|---|---|
| AZ Groeninge Kortrijk, | |
| AZ Maria Middelares Ghent, | |
| Actualidad Basada en la Investigación del Cáncer Guadalajara, | |
| Adana City Hospital Adana, | |
| AdventHealth Cancer Institute Orlando, Florida | |
| Aichi Cancer Center Nagoya, Aichi-ken | |
| Alliance Cancer Specialists at Main Line Penn Wynne, Pennsylvania | |
| Ankara Bilkent Sehir Hastanesi Ankara, | |
| Antoni van Leeuwenhoek Amsterdam, | |
| Arizona Oncology Associates PC NAHOA Prescott, Arizona | |
| Asan Medical Center Seoul, | |
| Asian Institute Of Gastroenterology Hyderabad, | |
| Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia Vitória, | |
| Assuta MC Tel Aviv, | |
| Astera Cancer Care East Brunswick, New Jersey | |
| Azienda Ospedaliero Universitaria Pisana Pisa, | |
| Azienda Sanitaria Universitaria Friuli Centrale ASU FC Udine, | |
| B P Poddar Hospital and Medical research Limited Kolkata, | |
| Bakirkoy Training and Research Hospital Istanbul, | |
| Banner MD Anderson Cancer Center Gilbert, Arizona | |
| Beijing Cancer Hospital Beijing, | |
| Beijing Friendship Hospital Capital Medical University Beijing, | |
| Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku Bialystok, | |
| Birmingham Heartlands Hospital Birmingham, | |
| CBCC Global Research Bakersfield, California | |
| CHU de Poitiers Poitiers, | |
| COI Centro Oncologico Internacional Tijuana Tijuana, | |
| Cancer And Hematology Centers of Western Michigan PC Grand Rapids, Michigan | |
| Cancer and Blood Specialty Clinic Los Alamitos, California | |
| Castle Hill Hospital Hull, | |
| Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman Liège, | |
| Centro Oncologico Personalizado Cope S De R L De C V Mexico City, | |
| Centro Oncologico de Chihuahua Chihuahua City, | |
| Centrul Medical Unirea SRL Brasov, | |
| Chang Gung Memorial Hospital Taoyuan, | |
| Charite Universitatsmedizin Berlin Campus Virchow Klinikum Berlin, | |
| Chiang Mai University Chiang Mai, | |
| Chiba Cancer Center Chiba, Chiba | |
| Christian medical Vellore, | |
| Clinica Univ. de Navarra Pamplona, | |
| Clinica de Oncologie Sf Nectarie Craiova, | |
| Concord Hospital Concord, | |
| Cuidados Oncologicos Querétaro, | |
| Deenanath Mangeshkar Hospital and Research Centre Pune, | |
| Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital Ankara, | |
| ETZ TweeSteden Tilburg, | |
| Eastern Connecticut Hematology & Oncology Assoc. Norwich, Connecticut | |
| Erasmus MC Rotterdam, | |
| Florida Cancer Specialists East West Palm Beach, Florida | |
| Florida Cancer Specialists North Region St. Petersburg, Florida | |
| Florida Cancer Specialists South Fort Myers, Florida | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fred Hutchinson Cancer Research Center Seattle, Washington | |
| Fudan University Shanghai Cancer Center Shanghai, | |
| Fundacao Antonio Prudente A C Camargo Cancer Center São Paulo, | |
| Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base São José do Rio Preto, | |
| Fundacao Pio XII Barretos, | |
| Fundação Doutor Amaral Carvalho Jaú, | |
| Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo São Paulo, | |
| Fundação Universidade de Caxias do Sul Caxias do Sul, | |
| Gansu Provincial Cancer Hospital Lanzhou, | |
| Ganzhou Cancer Hospital Ganzhou, | |
| Gazi University Hospital Ankara, | |
| Grady Memorial Hospital Delaware, Ohio | |
| Guangdong Provincial People's Hospital Guangzhou, | |
| Gulhane Egitim ve Arastirma Hastanesi Ankara, | |
| Hadassah Medical Center Jerusalem, | |
| Harbin Medical University Cancer Hospital Harbin, | |
| Hattiesburg Clinic Hattiesburg, Mississippi | |
| Health Pharma Queretaro SA de CV Querétaro, | |
| Henry Ford Hospital Detroit, Michigan | |
| Hopital Haut Leveque Pessac, | |
| Hosp Univ Vall D Hebron Barcelona, | |
| Hosp. Clinico Univ. de Valencia Valencia, | |
| Hosp. Gral. Univ. Gregorio Marañon Madrid, | |
| Hosp. Univ. 12 de Octubre Madrid, | |
| Hosp. Univ. Ramon Y Cajal Madrid, | |
| Hosp. Virgen Del Rocio Seville, | |
| Hosp. de La Santa Creu I Sant Pau Barcelona, | |
| Hospital Kuala Lumpur Kuala Lumpur, | |
| Hospital Nossa Senhora da Conceicao S A Porto Alegre, | |
| Hospital Pulau Pinang George Town, Pulau Pinang | |
| Hospital Raja Permaisuri Bainun Ipoh, | |
| Hospital Santa Izabel Santa Casa de Misericordia da Bahia Salvador, | |
| Hospital Umum Sarawak Kuching, | |
| Hospital Universitario Dr Jose Eleuterio Gonzalez Nuevo León, | |
| Hubei Cancer Hospital Wuhan, | |
| Huizhou Central People's Hospital Huizhou, | |
| Hunan Cancer Hospital Changsha, | |
| Illinois CancerCare Peoria, Illinois | |
| Institut Jules Bordet Anderlecht, | |
| Institut Kanser Negara Clinical Research Center Putrajaya, | |
| Institut Sainte Catherine Avignon, | |
| Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca Cluj-Napoca, | |
| Institutul Regional de Oncologie Iasi Iași, | |
| Instytut Centrum Zdrowia Matki Polki Lodz, | |
| Ironwood Cancer and Research Center Chandler, Arizona | |
| Istituto Clinico Humanitas Rozzano, Lombardy | |
| Istituto Dei Tumori Di Milano Milan, | |
| Istituto Oncologico Veneto - IRCCS Padua, | |
| Jolimont Haine Saint Paul La Louviere, | |
| Kaohsiung Medical University Chung Ho Memorial Hospital Kaohsiung City, | |
| Karolinska Universitetssjukhuset Stockholm, | |
| Kindai University Hospital Ōsaka-sayama, | |
| Klinikum der Universitaet Muenchen Munich, | |
| Korea University Anam Hospital Seoul, | |
| Krankenhaus NorthWest Frankfurt am Main, | |
| Kyungpook National University Chilgok Hospital Deagu, | |
| Liaoning Cancer Hospital and Institute Shenyang, Liaoning | |
| Linkou Chang Gung Memorial Hospital Taoyuan District, | |
| Los Angeles Cancer Network Glendale, California | |
| MD Anderson Cancer Center Houston, Texas | |
| Mahamana Pandit Madan Mohan Malviya Cancer Centre Varanasi, | |
| Markhot Ferenc Oktatokorhaz es Rendelointezet Eger, | |
| Marmara University Pendik Training Hospital Istanbul, | |
| Mary Bird Perkins Cancer Center Baton Rouge, Louisiana | |
| Meander Medisch Centrum Amersfoort, | |
| MedStar Franklin Square Medical Center Rosedale, Maryland | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Montefiore Einstein Comprehensive Cancer Center The Bronx, New York | |
| Mount Sinai Medical Center Campus Miami Beach, Florida | |
| Mount Vernon Cancer Centre Northwood, | |
| NYU Langone Medical Center NYU Hematology Associates New York, New York | |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warsaw, | |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach Gliwice, | |
| National Cancer Center Hospital Tokyo, | |
| National Cancer Center Hospital East Kashiwa, | |
| National Center for Tumor Diseases NCT Heidelberg, | |
| National Cheng Kung University Hospital Tainan, | |
| National Hospital Organization Osaka National Hospital Osaka, | |
| National Taiwan University Hospital Taipei, | |
| Nebraska Cancer Specialists Omaha, Nebraska | |
| Necmettin Erbakan University Meram Medical Faculty Konya, | |
| Neolife Medical Center Bucharest Bucharest, | |
| New York Cancer and Blood Specialists Shirley, New York | |
| Oncocenter Timișoara, | |
| Oregon Health and Science University Portland, Oregon | |
| Osaka International Cancer Institute Osaka, Osaka | |
| Pan American Center for Oncology Trials LLC San Juan, | |
| Pecsi Tudomanyegyetem Pécs, | |
| Peking University First Hospital Beijing, | |
| Pelican Impex SRL Oradea, | |
| Perlmutter Cancer Center at NYU Long Island Mineola, New York | |
| Piedmont Cancer Institute Atlanta, Georgia | |
| Ponderas Academic Hospital Bucharest, | |
| Prince of Wales Hospital Hong Kong, | |
| Providence Medical Foundation Fullerton, California | |
| Providence Regional Cancer System Lacey, Washington | |
| Queen Elizabeth Hospital Birmingham, | |
| Queen Mary Hospital Hong Kong, | |
| Rabin Medical Center Petah Tikva, | |
| Radboud University Medical Center Nijmegen, | |
| Rajiv Gandhi Cancer Institute And Research Centre New Delhi, National Capital Territory of Delhi | |
| Ramathibodi Hospital Bangkok, Bangkok | |
| Rambam Medical Center Haifa, | |
| Rocky Mountain Cancer Centers Littleton, Colorado | |
| Royal Marsden Hospital London, | |
| SCRI Oncology Partners Nashville, Tennessee | |
| SPZOZ Ministerstwa Spraw Wewnetrznych z Warminsko Mazurskim Centrum Onkologii w Olsztynie Olsztyn, | |
| SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego Opole, | |
| Safdarjung Hospital New Delhi, | |
| Sahlgrenska Universitetssjukhuset Gothenburg, | |
| Sakarya University Training and Research Hospital Sakarya, | |
| Samsung Medical Center Seoul, | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital Yonsei University Health System SeodaemunGu, Seoul Teugbyeolsi | |
| Sheba Medical Center Ramat Gan, | |
| Shizuoka Cancer Center Nagaizumi-cho,Sunto-gun, | |
| Siriraj Hospital Bangkok, | |
| Skanes universitetssjukhus Lund, | |
| Songklanagarind Hospital Songkhla, | |
| Spitalul Memorial Baneasa Bucharest, | |
| St Bartholomew's Hospital London, | |
| St James University Hospital Leeds, | |
| St. Bernard's Medical Center Jonesboro, Arkansas | |
| Sun Yat Sen University Cancer Center Guangzhou, Guangdong | |
| Szegedi Tudomanyegyetem Szeged, | |
| Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza Brzozów, | |
| Södersjukhuset Stockholm, | |
| Taichung Veterans General Hospital Taichung, | |
| Taipei Veterans General Hospital Taipei, | |
| Tata Memorial Hospital Mumbai, Maharashtra | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| Tennessee Oncology Nashville, Tennessee | |
| Tennessee Oncology Nashville, Tennessee | |
| Texas Oncology - San Antonio San Antonio, Texas | |
| Texas Oncology DFW Dallas, Texas | |
| Texas Oncology West Texas Abilene, Texas | |
| The Cancer Institute Hospital of JFCR Kōtō City, | |
| The Catholic University of Korea Seoul St Mary s Hospital Seoul, | |
| The First Affiliated Hospital of NanChang University Nanchang, Jiangxi | |
| The First Bethune Hospital of Jilin University Changchun, Jilin | |
| The Second Affiliated Hospital of Zhejiang University Hangzhou, | |
| The Sixth Affiliated Hospital Sun Yat sen University Guangzhou, | |
| The University of Osaka Hospital Suita, | |
| Thomas Jefferson University Philadelphia, Pennsylvania | |
| Tianjin Medical University Cancer Institute and Hospital Tianjin, | |
| Torrance Memorial Physicians Network Torrance, California | |
| UCLA Los Angeles, California | |
| USC Norris Comprehensive Cancer Center Los Angeles, California | |
| UT Health East Texas HOPE Cancer Center Tyler, Texas | |
| UT Southwestern Medical Center Dallas, Texas | |
| UZ Antwerpen Edegem, | |
| Universitair Ziekenhuis Leuven Leuven, | |
| University Cancer and Blood Center LLC Athens, Georgia | |
| University College Hospital London, | |
| University Hospital of Cleveland Cleveland, Ohio | |
| University Malaya Medical Centre Kuala Lumpur, Kuala Lumpur | |
| University Of Pittsburgh Medical Center UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | |
| University of Colorado Denver Anschultz Medical Campus Aurora, Colorado | |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | |
| Universitätsmedizin der Johannes Gutenberg Universität Mainz Mainz, | |
| Uniwersyteckie Centrum Kliniczne Gdansk, | |
| Uppsala University Uppsala, | |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Virginia Cancer Specialists Arlington, Virginia | |
| Warringal Private Hospital Heidelberg, | |
| Washington University School of Medicine St Louis, Missouri | |
| West China Hospital of Sichuan University Chengdu, | |
| Western Health Sunshine Hospital St Albans, | |
| Winship Cancer Institute Emory University Atlanta, Georgia | |
| Wojewodzki Szpital Specjalistyczny Biała Podlaska, | |
| Yitzhak Shamir Medical Center Beer Yaakov, | |
| Zhejiang Cancer Hospital Hangzhou, |
Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI) (CLEAR-AKI)
Novartis Pharmaceuticals - novartis.email@novartis.com
NCT05996835
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Inclusion Criteria:
• Signed informed consent must be obtained in accordance with local regulations.
• ≥ 18 to ≤ 85 years of age
• Admitted to ICU or intermediate care unit/ high dependency care unit (HDU)
• Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on: * Suspected or confirmed infection AND * Acute increase of SOFA score of 2 or more (excluding renal component). The baseline SOFA score should be assumed to be zero unless the participant is known to have pre-existing (acute or chronic) organ dysfunction before the onset of infection
• Diagnosis of AKI Stage 1 or greater per the following criterion at randomization: An absolute increase in serum or plasma creatinine by ≥ 0.3 mg/dL (≥ 26.5 µmol/L) within 48 hours or presumed to have occurred in the previous 48 hours as compared to the reference serum creatinine. * For participants with hospital-acquired AKI, a stable serum creatinine obtained in the hospital prior to AKI diagnosis should be used as the reference serum creatinine. * For participants presenting from community, the reference serum creatinine should be estimated using the following order of preference:
• The most recent value within 3 months of the hospital admission. If not available:
• The most recent value between 3 and 12 months prior to hospital admission. If not available:
• At hospital admission Exclusion criteria
• Not expected to survive for 24 hours
• Not expected to survive for 30 days due to medical conditions other than SA-AKI
• History of CKD with a documented estimated GFR \<30 mL/min prior to admission to hospital
• eGFR \<45mL/min at admission without any other reference serum eGFR within last 12-months
• Receiving RRT or a decision has been made to initiate RRT within 24 hours after randomization
• Weight is less than 40 kg or more than 125 kg.
• Limitations to the use of mechanical ventilation, RRT or vasopressors/inotropes (N.B. limitations on Cardiopulmonary resuscitation (CPR)e.g., do-not-resuscitate orders are not an exclusion criterion unless associated with likely poor outcome in next 24 hours)
• Sepsis diagnosis according to sepsis inclusion criteria for a period longer than 72 hours prior to ICU admission
• AKI diagnosis according to AKI inclusion criteria over 48 hours after admission to ICU
• Inability to administer study drug within 24 hours of diagnosis of AKI according to AKI inclusion criteria
• Presence of AKI, in the Investigator's opinion, as suggested by clinical manifestation, e.g., prolonged oliguria or severe renal dysfunction on admission without a history of CKD, for a period longer than 24 hours prior to study drug administration
• Evidence of recovery from AKI based on the investigator's clinical judgement prior to randomization
• AKI is most likely attributable to other causes than sepsis, such as nephrotoxic drugs (Non-steroidal anti-inflammatory drugs (NSAIDs), contrast, aminoglycosides, etc.) or renal perfusion-related (acute abdominal aortic aneurysm, dissection, renal artery stenosis), urinary obstruction
• Documented (biopsy proven) or suspected history of acute or sub-acute kidney diseases such as rapidly progressive glomerular nephritis (RPGN) and acute interstitial nephritis (AIN)
• Patients who are post-nephrectomy
• Patients with permanent incapacitation
• Patients who are thrombocytopenic at screening (platelet count \<50,000 per microliter) who have active/uncontrolled bleeding or who present current or past conditions indicating high risk for bleeding in the opinion of the investigator (e.g. coagulopathies, previous history of major non-traumatic bleeding etc.)
• Immunosuppressed patients * History of immunodeficiency diseases * Receiving immunosuppressant treatment or on chronic high doses (high-dose therapy exceeding 2 weeks of treatment) of steroids equivalent to prednisone/prednisolone 0.5 mg/kg/day, including solid organ transplant patients. Patients with septic shock treated with corticosteroids (as per the Surviving Sepsis Guidelines) can be included.
• Patients with known or presumed latent or active TB based on clinical history or imaging e.g. patients on TB preventive therapy or close/household contacts of pulmonary TB patients
• Known active hepatitis B or C infection (clinical diagnosis or positive infection serology), or advanced chronic liver disease, confirmed by a Child-Pugh score of 10-15 (Class C)
• Acute pancreatitis with no established source of infection
• Active hematological malignancy (previous hematological malignancies that are not actively treated are allowable)
• Burns requiring ICU treatment
• Sepsis attributed to confirmed COVID-19
• Use of other investigational drugs within 5 half-lives of enrollment, within 30 days (e.g., small molecules) or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations
• History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes
• Any medical conditions that could significantly increase risk of participants' safety by participating in this study according to investigator's judgement
• Women with a positive pregnancy test, pregnancy or breast feeding
• Women of childbearing potential, unless they are using highly effective methods of contraception for the entire duration of the trial.
BIOLOGICAL: TIN816 70 mg lyophilisate powder, OTHER: Placebo
Acute Kidney Injury Due to Sepsis
Sepsis, acute kidney injury, anti-inflammatory, immunosuppression, intensive care unit
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Show 122 locations
Study Locations
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| Location | Contacts |
|---|---|
| Baylor Scott and White Dallas, Texas | Daniela Gonzalez - (Daniela.Gonzalez1@BSWHealth.org) |
| Baystate Medical Center Springfield, Massachusetts | Lesley Desouza - (Lesley.desouza@baystatehealth.org) |
| Beth Israel Deaconess Med Center Boston, Massachusetts | Carlo Ottanelli - (cottanel@bidmc.harvard.edu) |
| Emory Johns Creek Hospital Johns Creek, Georgia | Amy Anderson - (amy.anderson@emory.edu) |
| Endeavor Health Glenview, Illinois | Catherine Futoransky - (cfutoransky@northshore.org) |
| Good Samaritan Hospital Corvallis, Oregon | Kristen Moylan - (kmoylan@samhealth.org) |
| Henry Ford Hospital Detroit, Michigan | |
| Inova Fairfax Hospital Falls Church, Virginia | Kedir Seid - (Kedir.Seid@inova.org) |
| Lahey Hospital and Medical Center Burlington, Massachusetts | Caroline Schissel - (caroline.schissel@lahey.org) |
| Massachusetts General Hospital Boston, Massachusetts | Sydney Olafsen - (solafsen@mgh.harvard.edu) |
| Mayo Clinic Rochester Rochester, Minnesota | Mitchell Strand - (Strand.Mitchell@mayo.edu) |
| Montefiore Medical Center The Bronx, New York | Brenda Lopez - (brenda.lopez@einsteinmed.edu) |
| Montefiore Medical Center The Bronx, New York | Daniel Ceusters - (dceuster@montefiore.org) |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Novartis Investigative Site London, | |
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| Ohio State University Medical Center Columbus, Ohio | Sarah Karow - (Sarah.Karow@osumc.edu) |
| Providence Med Resch Center and Chindren Hosp Spokane, Washington | |
| Stanford Healthcare Stanford, California | Kelley Logan - (kalogan@stanford.edu) |
| Temple University Philadelphia, Pennsylvania | Ellen Bedenko - (ellen.bedenko@temple.edu) |
| U Of Pittsburgh Med Ctr Pittsburgh, Pennsylvania | Tina Vita - (vitatm@upmc.edu) |
| UC San Francisco Medical Center San Francisco, California | Aqsa Khan - (aqsa.khan@ucsf.edu) |
| Univ Of Iowa Hospitals And Clinics Iowa City, Iowa | Mc Lean Sunderland - (mclean-sunderland@uiowa.edu) |
| Univ Of Iowa Hospitals And Clinics Iowa City, Iowa | |
| University of Alabama Birmingham, Alabama | Aleena Asif - (aleenaasif@uabmc.edu) |
| Utah Intermountain Medical Center Murray, Utah | Jose Romero - (Jose.Romero1@imail.org) |
| Virginia Commonwealth University Richmond, Virginia | Shawn Fenner - (shawn.fenner@vcuhealth.org) |
| Wake Forest Univ School of Medicine Winston-Salem, North Carolina | Tanmay Sura - (tsura@wakehealth.edu) |
DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With a Single Agent Chemotherapy
Boehringer Ingelheim - clintriage.rdg@boehringer-ingelheim.com
NCT05990738
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Inclusion Criteria:
• Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).
• Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
• Histologically or cytologically confirmed small cell lung cancer (SCLC). Patients with tumours with mixed histology are eligible only if SCLC component is predominant and represent at least 50% of the overall tumour tissue.
• Extensive stage - small cell lung cancer (ES-SCLC) that progressed or recurred following platinum-based treatment, and anti- programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) as applicable.
• Patients must be eligible for single agent chemotherapy treatment (used in the trial) according to label.
• Availability of archival tumour tissue sample.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Further inclusion criteria apply.
Exclusion Criteria:
• Previous treatment in this trial.
• Current enrolment in another investigational device or drug trial, or \<30 days since ending another investigational device or drug trial(s).
• Untreated or symptomatic brain metastases. Participants with treated, stable brain metastases are eligible provided they meet the following criteria: * Radiotherapy or major surgery for brain metastases was completed at least 2 weeks (for radiotherapy) or 4 weeks (for major brain metastases surgery) prior to the first administration of BI 764532. * Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant central nervous system (CNS) disease.
• Presence of leptomeningeal carcinomatosis.
• Prior participation in clinical trials of BI 764532, including receiving standard of care in these trials OR prior treatment with T cell engager (TcE) or cell therapies targeting delta-like ligand 3 (DLL3).
• Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, CTCAE Grade 2 neuropathy, or Grade 2 endocrinopathies controlled by replacement therapy).
• Major surgery (major according to the investigator's assessment) within 28 days prior to first administration of BI 764532 or planned during treatment period, e.g. hip replacement.
• Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except
• effectively treated non-melanoma skin cancers
• effectively treated carcinoma in situ of the cervix
• effectively treated ductal carcinoma in situ
• other effectively treated malignancy that is considered cured by local treatment Further exclusion criteria apply.
DRUG: BI 764532, DRUG: Topotecan, DRUG: Single agent chemotherapy
Small Cell Lung Carcinoma (SCLC)
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| Location | Contacts |
|---|---|
| East Carolina University Greenville, North Carolina | |
| HOP Civil Strasbourg, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| INS Curie Paris, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| INS Gustave Roussy Villejuif, | Boehringer Ingelheim - (france@bitrialsupport.com) |
| Leicester Royal Infirmary Leicester, | Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com) |
| Mayo Clinic - Florida Jacksonville, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Polish Mother's Memorial Hospital - Research Institute Lodz, | Boehringer Ingelheim - (polska@bitrialsupport.com) |
| Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg Heidelberg, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| University of Kansas Cancer Center Kansas City, Kansas | |
| University of Miami Miami, Florida | Boehringer Ingelheim - (unitedstates@bitrialsupport.com) |
| Universitätsklinikum Carl Gustav Carus Dresden Dresden, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Universitätsklinikum Erlangen Erlangen, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Universitätsklinikum Würzburg AÖR Würzburg, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz, | Boehringer Ingelheim - (deutschland@bitrialsupport.com) |
| Virginia Commonwealth University Richmond, Virginia |
The Vanguard Study: Testing a New Way to Screen for Cancer
ctrrecruit@vcu.edu
NCT06995898
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Inclusion Criteria:
* Ages 45-75 years old
* Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment
* Agree to allow collection of information from their medical records for study-related purposes
* Understand and be able to complete informed consent and participant questionnaires in English, Spanish, or Arabic
* Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion
Exclusion Criteria:
* Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years
* Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ) or nonmelanoma skin cancer are eligible
* Ongoing cancer diagnostic work-up
* Ongoing participation in another study of an investigational cancer screening test or technology
* Currently breastfeeding or pregnant, or planning to become pregnant in the next year PROCEDURE: Biospecimen Collection, DEVICE: Device Usage, OTHER: Electronic Health Record Review, PROCEDURE: Multi-Cancer Detection Test, PROCEDURE: Multi-Cancer Detection Test, OTHER: Questionnaire Administration
Bladder Carcinoma, Breast Carcinoma, Colorectal Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Liver Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Prostate Carcinoma
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Study Locations
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| Location | Contacts |
|---|---|
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (ctsucontact@westat.com) |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | Site Public Contact - (CTOResearch@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 Sterling Heights, Michigan | Site Public Contact - (ctsucontact@westat.com) |
| Henry Ford Medical Center - Detroit Northwest Detroit, Michigan | Site Public Contact - (kkeenan1@hfhs.org) |
| Henry Ford Medical Center - Livonia Livonia, Michigan | Site Public Contact - (kkeenan1@hfhs.org) |
| Henry Ford Medical Center - Plymouth Plymouth, Michigan | Site Public Contact - (kkeenan1@hfhs.org) |
| Henry Ford Medical Center - Royal Oak Royal Oak, Michigan | Site Public Contact - (kkeenan1@hfhs.org) |
| Henry Ford Medical Center - Troy Troy, Michigan | Site Public Contact - (kkeenan1@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Cottage Grosse Pointe Farms, Michigan | |
| 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) |
| Inova Fair Oaks Hospital Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Schar Cancer Institute Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente-Division of Research Pleasanton, California | |
| Kaiser Permanente-Franklin Denver, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Lone Tree Lone Tree, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Rock Creek Lafayette, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Keefe Memorial Hospital Cheyenne Wells, Colorado | Site Public Contact - (cmillsap@keefemh.org) |
| Medical Center of the Rockies Loveland, Colorado | |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Sentara Martha Jefferson Hospital Charlottesville, Virginia | |
| Sentara Norfolk General Hospital Norfolk, Virginia | |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (ctsucontact@westat.com) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.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) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)
ctrrecruit@vcu.edu
NCT05638295
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Inclusion Criteria:
* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-E5 based on the presence of an actionable mutation as defined in EAY191
* Patient must be enrolled on the ComboMATCH Registration Protocol (EAY191) at the time of registration/randomization to the EAY191-E5 study
* Patient must be \>= 18 years of age
* Patient must have a KRAS G12C alteration as determined by the ComboMATCH screening assessment
* Patient must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191-E5)
* NOTE: The current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website: www.ctsu.org (final URL pending)
* NOTE: Novel/Dynamic aMOI can be submitted for review per the process described in the ComboMATCH registration protocol
* Patient must have cytologically/histologically confirmed advanced/metastatic solid tumor
* Patient must have progressed on at least one line of standard of care therapy in the advanced/metastatic setting
* NOTE: Patients who have progressed on a prior human epidermal growth factor receptor (EGFR) inhibitor will meet this criterion
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 (or Karnofsky performance status \>= 60%)
* Patient must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) documented by imaging obtained within 28 days prior to registration/randomization
* Patient must not have any serious active infection within 4 weeks prior to EAY191-E5 registration/randomization (e.g., requiring hospitalization and/or intravenous \[IV\] antibiotics) or currently receiving oral or IV antibiotics for the treatment of infection. Patients receiving prophylactic antibiotics are eligible
* Patient must have the ability to retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption
* Patient must not have any history of or current evidence of non-infectious interstitial lung disease (ILD)/pneumonitis
* Patient must not have a history of allergic reactions attributed to either of the study agents or to agents of similar chemical or biologic composition
* Patient must have completed full treatment cycle 21 days prior to EAY191-E5 registration/randomization if they have received prior chemotherapy, biological cancer therapy, radiation therapy or an investigational agent/device. Patients must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from any adverse events due to prior cancer therapy (with the exception of alopecia)
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration/randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for at least 6 months after the last dose of protocol treatment. Patients must not breastfeed while receiving protocol treatment and for one week (7 days) after the last dose of AMG 510 (sotorasib) and 2 months after the last dose of panitumumab
* Patients must not have neuropathy ≥ grade 2 within 14 days prior to registration/randomization
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
* Human immunodeficiency virus (HIV)-infected patients no effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* 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 history, 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 trail, patients should be class 2B or better
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 28 days prior to protocol registration/randomization)
* Aspartate aminotransferase (AST) (serum (glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (\[SGPT\]) \< 3 x institutional upper limit of normal (obtained ≤ 28 days prior to protocol registration/randomization)
* Creatinine =\< 1.5 x institutional ULN OR creatinine clearance \> 50 mL/min/1.73 m\^2 for patients with creatinine levels \> 1.5 mg/dL as per Cockcroft-Gault (obtained ≤ 28 days prior to protocol registration/randomization)
* COHORT I: Patient must not have colorectal cancer or non-small cell lung cancer
* COHORT I: Patient must not have been previously treated with a KRAS G12C inhibitor
* COHORT II: Patient must have progressed after treatment at the recommended phase II dose (RP2D) of any KRAS G12C inhibitor
* NOTE: Patients on cohort 1 who experience progression on Regimen 2 (AMG 510 \[sotorasib\] alone) may be eligible to enroll on cohort 2 and receive combination treatment with panitumumab and AMG 510 (sotorasib). Patients must meet performance status requirements and laboratory values as above and must be begin treatment within 7 days of enrollment. Migration to cohort 2 must take place within 6 months of progression, with no intervening anti-cancer therapy given.
* NOTE: Cohort migration following disease progression is dependent on a slot being available. MATCHBox makes the new treatment assignment following initiation of a step 2 registration for this treatment trial
* COHORT II: Patient must not have been previously treated with a KRAS G12C inhibitor in combination with an EGFR inhibitor PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Panitumumab, DRUG: Sotorasib
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
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| 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) |
| 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 - Oak Lawn Oak Lawn, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.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) |
| 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) |
| 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) |
| Bristol Regional Medical Center Bristol, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| 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) |
| Carle BroMenn Medical Center Normal, 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) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.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) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Corewell Health Beaumont Troy Hospital Troy, Michigan | |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Dearborn Hospital Dearborn, Michigan | |
| Corewell Health Farmington Hills Hospital Farmington Hills, Michigan | |
| Corewell Health William Beaumont University Hospital Royal Oak, Michigan | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dayton Physician LLC - Englewood Dayton, Ohio | |
| 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 Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| ECOG-ACRIN Cancer Research Group Philadelphia, Pennsylvania | Kristen R. Spencer - (Kristen.Spencer@nyulangone.org) |
| 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 Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| Kettering Medical Center Kettering, Ohio | |
| 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) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Loyola University Medical Center Maywood, Illinois | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin | Site Public Contact - (oncologyclinicaltrials@mhemail.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 - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| National Institutes of Health Clinical Center Bethesda, Maryland | |
| 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) |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | |
| 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) |
| 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) |
| 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) |
| Rapid City Regional Hospital Rapid City, South Dakota | Site Public Contact - (research@monument.health) |
| Regional Cancer Center at Johnson City Medical Center Johnson City, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| 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 Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| 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 Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| 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) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Angeles Clinic and Research Institute - West Los Angeles Office Los Angeles, California | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| ThedaCare Cancer Care - Berlin Berlin, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - New London New London, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Shawano Shawano, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Waupaca Waupaca, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Medical Center - Neenah Neenah, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| 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) |
| 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 | |
| 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 Hollywood Hollywood, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Illinois Chicago, Illinois | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| 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 South Alabama Mitchell Cancer Institute Mobile, Alabama | Site Public Contact - (pfrancisco@usouthal.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) |
| VA Palo Alto Health Care System Palo Alto, California | |
| 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) |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wellmont Holston Valley Hospital and Medical Center Kingsport, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| West Virginia University Charleston Division Charleston, West Virginia |
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
BCC Enroll - BCCEnroll@pennstatehealth.psu.edu
NCT05489887
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Inclusion Criteria:
• Diagnosis: Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites. Subjects with the following disease stages at diagnosis are eligible, if they meet the other specified criteria:
• Subjects with newly diagnosed neuroblastoma with INRGSS Stage M disease with either of the following features:
• MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR
• 365 days to ≥ 547 days of age without MYCN amplification, but unfavorable biologic features such as unfavorable histology (INPC) or diploid tumor (DNA index=1) or the presence of any segmental chromosome aberration (SCA) (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q); OR
• Age \> 547 days of age regardless of biologic features Subjects with newly diagnosed neuroblastoma with INRGSS Stage MS disease with either of the following:
• MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals); OR
• 365 days to ≥ 547 days (18 months) of age without MYCN amplification, but unfavorable biologic features such as unfavorable histology (INPC) or diploid tumor (DNA index=1) or SCA as above Subjects with newly diagnosed neuroblastoma INRGSS Stage L2 disease with either of the following:
• MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals); OR
• 18 months to \<5 years of age without MYCN amplification, but with unfavorable histology (INPC); OR
• ≥5 years of age without MYCN amplification, but with undifferentiated or poorly differentiated INPC Subjects with newly diagnosed neuroblastoma INRGSS Stage L1 disease that is incompletely resected with MYCN amplification. Subjects \> 547 days of age initially diagnosed with INRGSS Stage L1, L2 or MS disease who progressed to Stage M without prior chemotherapy may enroll within 4 weeks of progression to Stage M. Subjects ≥ 365 days of age initially diagnosed with MYCN amplified INRGSS Stage L1 disease who progress to Stage M without systemic therapy may enroll within 4 weeks of progression to Stage M.
• Subjects must be age ≤ 21 years at initial diagnosis.
• Subjects must be \>12 months of age at enrollment.
• Adequate cardiac function defined as:
• Shortening fraction of ≥ 27% by echocardiogram, or
• Ejection fraction of ≥ 50% by radionuclide evaluation or echocardiogram.
• Adequate liver function must be demonstrated, defined as:
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND
• ALT (SGPT) \< 5 x upper limit of normal (ULN) for age
• Subjects must have adequate renal function defined as an estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70. The Bedside Schwartz equation is: \[(0.413) X (Height in cm)\] / SCr
• A negative serum pregnancy test is required for female participants of childbearing potential (≥13 years of age or after onset of menses)
• Both male and female post-pubertal study subjects must be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of \<1% per year when used consistently and correctly) from the time of informed consent until 6 months after study treatment discontinuation. Such methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (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, sexual abstinence.
• Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Exclusion Criteria:
• Subjects who are less than 1 year of age
• Subjects who are 12-18 months of age with INRGSS Stage M and all stage L2 subjects with favorable biologic features (i.e., nonamplified MYCN, favorable pathology, and DNA index \> 1) are not eligible.
• Subjects who have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy.
• Treatment with immunosuppressive treatment (topical, inhaled and short-term emergency steroids excluded) within 4 weeks prior to enrollment
• Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and/or chronic oxygen requirement. In addition, room air pulse oximetry \< 94% and/or abnormal pulmonary function tests if these assessments are clinically indicated.
• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.)
• Subjects receiving any investigational drug concurrently.
• Subjects with any other medical condition, including but not limited to malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study
• Subjects with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of investigational medicinal products (IMPs) or to significantly increase the severity of the toxicities experienced from trial treatment.
DRUG: Naxitamab
High-risk Neuroblastoma
naxitimab, induction
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Show 23 locations
Study Locations
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| Location | Contacts |
|---|---|
| Arkansas Children's Hospital Little Rock, Arkansas | Susan Hall - (HallSF@archildrens.org) |
| Arnold Palmer Hospital for Children Orlando, Florida | Marie Frankos - (marie.frankos@orlandohealth.com) |
| Augusta University Health Augusta, Georgia | Kimberly Gray - (kigray@augusta.edu) |
| CHUQ Québec, Quebec | Valérie-Ève Julien - (Valerie-Eve.Julien@crchudequebec.ulaval.ca) |
| CIUSSS de l'Estrie-CHUS Sherbrooke, Quebec | Cassandra Leblanc Desrochers - (cassandra.leblanc-desrochers.ciussse-chus@ssss.gouv.qc.ca) |
| Cardinal Glennon Children's Hospital St Louis, Missouri | Gina Martin - (gina.martin@health.slu.edu) |
| Children's Hospital and Clinics of Minnesota Minneapolis, Minnesota | Nel Siemsen - (Nel.Siemsen@childrensmn.org) |
| Connecticut Children's Hospital Hartford, Connecticut | Nicole McCracken - (NMccracken@connecticutchildrens.org) |
| Dell Children's Blood and Cancer Center Austin, Texas | Rhea Robinson, RN - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | Andrea Siu, MPH - (andrea.siu@kapiolani.org) |
| Kentucky Children's Hospital Lexington, Kentucky | Brittany Fuller - (blfull2@email.uky.edu) |
| Levine Children's Hospital Charlotte, North Carolina | Jontyce Green, RN - (jontyce.green@atriumhealth.org) |
| Medical University of South Carolina Charleston, South Carolina | Liz Shewfelt - (shewfelt@musc.edu) |
| Nicklaus Children's Miami Miami, Florida | Jose RodriguezAlonso - (Jose.RodriguezAlonso@Nicklaushealth.org) |
| Penn State Milton S. Hershey Medical Center and Children's Hospital Hershey, Pennsylvania | Suzanne Treadway - (streadway@hmc.psu.edu) |
| Rady Children's Hospital San Diego, California | Sherri Brandsen - (sbrandsen@rchsd.org) |
| Randall Children's Hospital Portland, Oregon | Aaron White - (AJWHITE@lhs.org) |
| UCSF Benioff Children's Hospital Oakland- Oakland, California | Group Contact - (PedOncRschOAK@ucsf.edu) |
| UHC Sainte-Justine Montreal, Quebec | Guillaume Leblanc - (guillaume.leblanc.hsj@ssss.gouv.qc.ca) |
| University of Alabama, Children's Alabama Birmingham, Alabama | Jennifer Ward, MD - (jennifer.ward@aah.org) |
| University of Florida Gainesville, Florida | Ashley Bayne - (abayne@UFL.EDU) |
| Virginia Commonwealth University Richmond, Virginia | Mary Madu - (memadu@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina |
Pulmonary Hypertension Association Registry (PHAR)
Elizabeth Joseloff, PhD - PHAR@PHAssociation.org
NCT04071327
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Inclusion Criteria:
* All age groups
* Written informed consent
* Pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), or pediatric PH due to developmental lung disease
* Within 6 months of first outpatient visit at a PH Care Center
Exclusion Criteria:
* Diagnosis of WSPH Group 2 pulmonary hypertension
* Diagnosis of WSPH Group 3 pulmonary hypertension, except PH due to developmental lung disease
* Diagnosis of WSPH Group 5 pulmonary hypertension Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Hypertension
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Show 52 locations
Study Locations
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| Location | Contacts |
|---|---|
| Allegheny General Hospital Pittsburgh, Pennsylvania | Amresh Raina, MD - (amresh.raina@ahn.org) Kimberly Curry, RN - (kimberly.curry@ahn.org) |
| AnMed Health Anderson, South Carolina | Abhijit Raval, MD - (drravallung@gmail.com) Kelly Dickson, RRT - (kelly.dickson@anmedhealth.org) |
| Arizona Pulmonary Specialists, Ltd. Phoenix, Arizona | |
| Aurora St. Luke's Medical Center Milwaukee, Wisconsin | Michelle Cicona - (michelle.cicona@aurora.org) |
| Baylor Scott & White Plano, Texas | Sahil Bakshi, MD - (sahil.bakshi@bswhealth.org) Lucy Knight - (lucy.knight@bswhealth.org) |
| Children's Hospital Colorado Aurora, Colorado | Dunbar Ivy, MD - (dunbar.ivy@childrenscolorado.org) Kathleen Miller-Reed - (kathleen.miller-reed@childrenscolorado.org) |
| Cincinnati Children's Hospital Cincinnati, Ohio | Russel Hirsch, MD - (russel.hirsch@cchmc.org) Alyssa Rhode, BS - (alyssa.rhode@cchmc.org) |
| Columbia University Medical Center/NewYork-Presbyterian Hospital New York, New York | Erika S. Berman Rosenzweig, MD - (esb14@cumc.columbia.edu) Daniela Brady, FNP - (dm2069@cumc.columbia.edu) |
| Cottage Health System - Santa Barbara Pulmonary Associates Santa Barbara, California | Jeffrey S. Sager, MD, MS - (jsager@sblung.com) Caitlin Torchia, RN - (ctorchia@sbch.org) |
| Duke University Medical Center Durham, North Carolina | Kishan Parikh, MD - (kishan.parikh@duke.edu) Noely Martinez-Overby, CMA - (noely.martinez-overby@duke.edu) |
| Froedtert & Medical College of Wisconsin Milwaukee, Wisconsin | Kenneth W. Presberg, MD - (kpresber@mcw.edu) Amy Kimber, APNP - (akimber@mcw.edu) |
| Ft. Sanders Regional Medical Center Knoxville, Tennessee | Regina Overton-Barnes, APN - (rbarnes@statcaremed.net) |
| Henry Ford Hospital Detroit, Michigan | Rana L. Awdish, MD - (rawdish1@hfhs.org) Sheri Renaud, RN - (srenaud9@hfhs.org) |
| Indiana University Health Indianapolis, Indiana | Michael Duncan, MD - (mduncan3@iuhealth.org) Melissa Astin, BSN - (mastin@iuhealth.org) |
| Inova Fairfax Hospital Falls Church, Virginia | Oksana A. Shlobin, MD - (oksana.shlobin@inova.org) Edwinia Battle, BSN, CCRC - (edwinia.battle@inova.org) |
| Johns Hopkins University Baltimore, Maryland | Stephen C. Mathai, MD, MHS - (smathai4@jhmi.edu) Julie Shamberger, RN - (jshambe2@jhmi.edu) |
| KU Medical Center Kansas City, Kansas | Timothy Williamson, MD - (twillia1@kumc.edu) |
| Kentuckiana Pulmonary Associates Louisville, Kentucky | |
| LSU Healthcare Network Clinic New Orleans, Louisiana | Matthew Lammi, MD - (mlammi@lsuhsc.edu) Paula Lauto, RN - (plauto@lsuhsc.edu) |
| Mayo Clinic Rochester, Minnesota | Robert P. Frantz, MD - (frantz.robert@mayo.edu) |
| Mayo Clinic Florida Jacksonville, Florida | Charles D. Burger - (burger.charles@mayo.edu) Kristine Gundian, CRC - (gundian.kristine@mayo.edu) |
| Northside Hospital Atlanta, Georgia | Paul Boyce, MD, MPH - (paul.boyce@northside.com) Tamara Wakhisi - (tamara.wakhisi@northside.com) |
| Ochsner Medical Center New Orleans, Louisiana | Stacy Mandras, MD - (smandras@ochsner.org) Angela Penning - (angela.penning@ochsner.org) |
| Rhode Island Hospital Providence, Rhode Island | Corey E. Ventetuolo, MD, MS - (corey_ventetuolo@brown.edu) Amy Palmisciano, BSN - (apalmisciano@lifespan.org) |
| Seattle Children's Hospital Seattle, Washington | Delphine Yung, MD - (delphine.yung@seattlechildrens.org) Anne Davis, RN - (anne.davis@seattlechildrens.org) |
| Sentara Heart Hospital Norfolk, Virginia | Melinda Bullivant, MSN, RN, CCRC - (mmbulliv@sentara.com) |
| Stanford University Stanford, California | Doris Stanley, BS - (dstandley@stanford.edu) Patricia Del Rosario, RN - (pdelrosa@stanford.edu) |
| Texas Children's Hospital Houston, Texas | Nidhy Varghese, MD - (npvarghe@texaschildrens.com) Elise Whalen, MSN - (ecbockov@texaschildrens.com) |
| The Oregon Clinic Portland, Oregon | Jeffrey C. Robinson, MD - (jerobinson@orclinic.com) Stephanie Persons, BS - (spersons@orclinic.com) |
| UC Davis Health Sacramento, California | Nikhil Jaha - (nkjaha@ucdavis.edu) Cynthia Perry-Baker - (clpbaker@ucdavis.edu) |
| UC Health Cincinnati, Ohio | Jean M. Elwing, MD - (elwingj@ucmail.uc.edu) Jennifer Gilkison, RN, BSN - (gilkisjr@ucmail.uc.edu) |
| UC Health - Anschutz Medical Campus Aurora, Colorado | David Badesch, MD - (david.badesch@cuanschutz.edu) Kelly Hannon, RN - (kelly.hannon@cuanschutz.edu) |
| UCSF Benioff Children's Hospital San Francisco, California | Jeffrey Fineman, MD - (jeff.fineman@ucsf.edu) Jasmine Becerra - (jasmine.becerra@ucsf.edu) |
| UCSF Medical Center San Francisco, California | Teresa De Marco, MD - (teresa.demarco@ucsf.edu) Amanda Schnell Heringer, RN, CNS - (amanda.schnellheringer@ucsf.edu) |
| UNC Chapel Hill Chapel Hill, North Carolina | H. James Ford, MD - (hjford@med.unc.edu) Laura Nowicki, RN - (laura_nowicki@med.unc.edu) |
| UT Southwestern Medical Center Dallas, Texas | Sonja D. Bartolome, MD - (sonja.bartolome@utsouthwestern.edu) Balaji Kolasani - (balaji.kolasani@utsouthwestern.edu) |
| University of Connecticut Health Farmington, Connecticut | Raymond Foley, DO - (r.foley@uchc.edu) |
| University of Iowa Hospitals & Clinic Iowa City, Iowa | |
| University of MD Medical Group, PA Baltimore, Maryland | Gautam V. Ramani, MD - (gramani@som.umaryland.edu) Lioubov Poliokova - (lpoliako@som.umaryland.edu) |
| University of Minnesota Health Minneapolis, Minnesota | Thenappan Thenappan, MD - (tthenapp@umn.edu) Gretchen Piechel - (gpeichel@umn.edu) |
| University of Pennsylvania Philadelphia, Pennsylvania | Steven M. Kawut, MD, MS - (kawut@upenn.edu) Randi Goodman - (randi.goodman@pennmedicine.upenn.edu) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Marc A. Simon, MD, MS - (simonma@upmc.edu) Abby Sung - (sunga3@upmc.edu) |
| University of Rochester Medical Center Rochester, New York | R. James White, MD, PhD - (jim_white@urmc.rochester.edu) Allison Light-Mills, PhD - (allison_light@urmc.rochester.edu) |
| University of Utah Health Salt Lake City, Utah | John J. Ryan, MD - (john.ryan@hsc.utah.edu) Brittany Penn - (brittany.penn@hsc.utah.edu) |
| University of Virginia Charlottesville, Virginia | Sula Mazimba, MD - (sm8sd@hscmail.mcc.virginia.edu) Allison Raymond, RN, CCRC - (AEH4M@hscmail.mcc.virginia.edu) |
| University of Washington Seattle, Washington | Peter Leary, MD, PhD - (learyp@uw.edu) Genecelle Delossantos - (gen7@medicine.washington.edu) |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | James R. Runo, MD - (jrr@medicine.wisc.edu) Amy Chybowski, NP - (amy.chybowski@uwmf.wisc.edu) |
| VCU Medical Center Richmond, Virginia | Daniel Grinnan, MD - (daniel.grinnan@vcuhealth.org) Charnetta Lester - (charnetta.robinson@vcuhealth.org) |
| Vanderbilt Children's Hospital Nashville, Tennessee | Eric D. Austin, MD, MSc - (eric.austin@vumc.org) Karen Chaffin, NP - (karen.e.chaffin@vumc.org) |
| Vanderbilt University Medical Center Nashville, Tennessee | Anna R. Hemnes, MD - (anna.r.hemnes@vumc.org) |
| Washington University in St. Louis St Louis, Missouri | Murali M. Chakinala, MD - (chakinalam@wustl.edu) Ellen Newton-Lovato, RN - (elovato@wustl.edu) |
| Weill Cornell Medical Center New York, New York | Evelyn M. Horn, MD - (horneve@med.cornell.edu) Rosemarie Gadioma - (gadioma@nyp.org) |
A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
Jayson Garmizo - jayson.garmizo@immunitybio.com
NCT02138734
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Inclusion Criteria
• Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
• Cohort A: Histologically confirmed CIS (with or without Ta/T1 disease); Cohort B: Histologically confirmed high-grade papillary disease (Ta/T1 only).
• Patients are eligible if the diagnostic biopsy was done within 3 months of treatment start and a cystoscopy demonstrating no resectable disease was done within 6 calendar weeks (inclusive of 48 days) of treatment start (residual CIS is acceptable; patients with T1 disease must undergo repeat resection if muscularis propria is not present in each biopsy sample). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment.
• Upper tract imaging within 6 months prior to study entry must not be suspicious for upper tract malignancy.
• Currently eligible for intravesical BCG therapy.
• Age ≥ 18 years.
• Performance status: ECOG performance status of 0, 1, or 2.
• BCG-naive disease as defined as either of the following:
• Have not received prior intravesical BCG; or
• Previously received BCG, but stopped receiving more than 3 years before date of randomization.
• Laboratory tests performed within 21 days of treatment start:
• Absolute lymphocyte count ≥ Institutional lower limit of normal
• Absolute neutrophil count (AGC/ANC) ≥ 1,000/μL
• Platelets ≥ 100,000/µL \[Patients may be transfused to meet this requirement\]
• Hemoglobin ≥ 8 g/dL \[Patients may be transfused to meet this requirement\]
• Calculated glomerular filtration rate (GFR\*) \>40 mL/min or Serum creatinine ≤ 1.5 x ULN
• Total bilirubin ≤ 2.0 X ULN
• AST, ALT, ALP ≤ 3.0 X ULN
• Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction. PFT \> 50% FEV1 if clinically indicated by the investigator.
• Negative serum pregnancy test if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
• Female participants of childbearing potential must adhere to using a medically accepted method of birth control prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study.
• Provide signed informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations. * using the following Cockcroft-Gault equation to calculate the eGFR for this study: eGFR in mL/min = {(140-age in years) x (weight in kg) x F}/(serum creatinine in mg/dL x 72) Where F =1 if male; and 0.85 if female Exclusion Criteria
• Prior BCG treatment or known hypersensitivity to BCG. Patients who have received more than a single-dose post-operative treatment of mitomycin-C or gemcitabine following the most recent screening TURBT/biopsy are excluded.
• Concurrent use of other investigational agents (not including FDA-authorized drugs for the prevention and treatment of COVID-19).
• History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer or any other cancer within the past 5 years, except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage 1 or 2 cancer from which the patient is currently in complete remission, or stable prostate cancer (under active surveillance or hormone control).
• Symptomatic congestive heart failure (CHF), NYHA (New York Heart Association) Class III or IV or other clinical signs of severe cardiac dysfunction.
• Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.
• History or evidence of uncontrollable CNS disease.
• Known HIV-positive.
• Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
• Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions.
• Ongoing chronic systemic steroid therapy required (\>10 mg oral prednisone daily or equivalent).
• Women who are pregnant or nursing. Female patients of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.
• Psychiatric illness/social situations that would limit compliance with study requirements.
• Other illness that in the opinion of the investigator would exclude the patient from participating in this study.
• Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
• Cohort A: Histologically confirmed CIS (with or without Ta/T1 disease); Cohort B: Histologically confirmed high-grade papillary disease (Ta/T1 only).
• Patients are eligible if the diagnostic biopsy was done within 3 months of treatment start and a cystoscopy demonstrating no resectable disease was done within 6 calendar weeks (inclusive of 48 days) of treatment start (residual CIS is acceptable; patients with T1 disease must undergo repeat resection if muscularis propria is not present in each biopsy sample). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment.
• Upper tract imaging within 6 months prior to study entry must not be suspicious for upper tract malignancy.
• Currently eligible for intravesical BCG therapy.
• Age ≥ 18 years.
• Performance status: ECOG performance status of 0, 1, or 2.
• BCG-naive disease as defined as either of the following:
• Have not received prior intravesical BCG; or
• Previously received BCG, but stopped receiving more than 3 years before date of randomization.
• Laboratory tests performed within 21 days of treatment start:
• Absolute lymphocyte count ≥ Institutional lower limit of normal
• Absolute neutrophil count (AGC/ANC) ≥ 1,000/μL
• Platelets ≥ 100,000/µL \[Patients may be transfused to meet this requirement\]
• Hemoglobin ≥ 8 g/dL \[Patients may be transfused to meet this requirement\]
• Calculated glomerular filtration rate (GFR\*) \>40 mL/min or Serum creatinine ≤ 1.5 x ULN
• Total bilirubin ≤ 2.0 X ULN
• AST, ALT, ALP ≤ 3.0 X ULN
• Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction. PFT \> 50% FEV1 if clinically indicated by the investigator.
• Negative serum pregnancy test if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
• Female participants of childbearing potential must adhere to using a medically accepted method of birth control prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study.
• Provide signed informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations. * using the following Cockcroft-Gault equation to calculate the eGFR for this study: eGFR in mL/min = {(140-age in years) x (weight in kg) x F}/(serum creatinine in mg/dL x 72) Where F =1 if male; and 0.85 if female Exclusion Criteria
• Prior BCG treatment or known hypersensitivity to BCG. Patients who have received more than a single-dose post-operative treatment of mitomycin-C or gemcitabine following the most recent screening TURBT/biopsy are excluded.
• Concurrent use of other investigational agents (not including FDA-authorized drugs for the prevention and treatment of COVID-19).
• History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer or any other cancer within the past 5 years, except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage 1 or 2 cancer from which the patient is currently in complete remission, or stable prostate cancer (under active surveillance or hormone control).
• Symptomatic congestive heart failure (CHF), NYHA (New York Heart Association) Class III or IV or other clinical signs of severe cardiac dysfunction.
• Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.
• History or evidence of uncontrollable CNS disease.
• Known HIV-positive.
• Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
• Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions.
• Ongoing chronic systemic steroid therapy required (\>10 mg oral prednisone daily or equivalent).
• Women who are pregnant or nursing. Female patients of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.
• Psychiatric illness/social situations that would limit compliance with study requirements.
• Other illness that in the opinion of the investigator would exclude the patient from participating in this study.
BIOLOGICAL: BCG+N-803( 50mg BCG/ Instillation+ N-803( 400 μg/instillation). ), BIOLOGICAL: BCG( 50mg/Instillation)
Non-muscle Invasive Bladder Cancer
antitumor, BCG, bladder cancer, cancer, immunotherapy, instillation, interleukin-15, intravesical, naive, non-muscle invasive, transitional cell carcinoma, ALT-803, N-803
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Show 80 locations
Study Locations
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| Location | Contacts |
|---|---|
| Adult & Pediatric Urology Omaha, Nebraska | |
| Advanced Urology Institute Daytona Beach, Florida | Ashley Seigworth - (ashley.seigworth@auihealth.com) |
| Alaska Clinical Research Center Anchorage, Alaska | |
| All India Institute of Medical Sciences, Raipur Rajpura, | Ms. Bhavisha Mundafode - (bhavisha@kvclinicalresearch.com) |
| Apollo Vizag Visakhapatnam, | Ms. Ramyasree - (ramyasree@apolloari.com) |
| Arkansas Urology Little Rock, Arkansas | |
| Associated Medical Professionals of NY Syracuse, New York | Julia Wilson - (juwilson@us-uro.com) |
| Associated Urological Specialists Chicago, Illinois | Karolina Webb - (kwebb@uropartners.com) Cheryl Zinar - (czinar@midlanticurology.com) |
| Associated Urologists of North Carolina Raleigh, North Carolina | Kip Moffett - (kmoffett@auncurology.com) |
| B J Medical College & Civil Hospital, Asarwa, Ahmedaba Ahmedabad, | Mr. Chintan Sheth - (chintan.sheth@skycrapercrs.in) |
| Basavatarakam Indo American Cancer Hospital & Research Institute Banjara Hills, | Sanjeeva Reddy - (sanjeev.indoamerican@gmail.com) |
| Binayak Multispecialty Hospital Kolkata, | Mr. Dipendu Das - (soumendoc.das@gmail.com) |
| Central Ohio Urology Group Gahanna, Ohio | Sarah Faisal - (sarah.faisal@us-uro.com) Benjamin Carey - (BCarey@centralohiourology.com) |
| Chittaranjan National Cancer Institute Kolkata, | Firoz - (clinicalresearch.cnci@gmail.com) |
| Clinical Research Center of Florida Pompano Beach, Florida | |
| Comprehensive Urology Royal Oak, Michigan | Tarek Sangid - (tsangid@urologist.org) |
| Darakh Nursing Home and Kidney Stone Centre Aurangabad, Maharashtra | Prashant Darakh - (prashantdarakh.research@gmail.com) |
| Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire | Olajumoke Babalola - (Olajumoke.A.Babalola@hitchcock.org) Patrick Gaughan - (Patrick.M.Gaughan@hitchcock.org) |
| Eastern Connecticut Hematology & Oncology Associates Norwich, Connecticut | |
| Erlanger Health Chattanooga, Tennessee | Cam Hughes - (Christian.Hughes@erlanger.org) Lauren Stallons, RN, BSN - (Lauren.Stallons@erlanger.org) |
| Erode Cancer Centre Erode, Tamil Nadu | |
| Florida Urology Partners Riverview, Florida | Haydy Rojas - (hrojas@floridaurologypartners.com) |
| Guru Govnid Singh Medical College and Hospital Farīdkot, | Ms. Aanchal Tuteja - (aatuteja13@gmail.com) |
| HCG Bangalore Bengaluru, | MS Apoova - (apoorva.bu@hcgel.com) |
| HCG Cancer Centre Bangalore, | Gowtham K Penmetsa, MBBS, MS - (gowthamkrishnapenmetsa@gmail.com) |
| HCG Manavata Cancer Centre Nashik, | Rahnish Nagarkar, MBBS,MS, DNB - (drraj@manavatacancercentre.com) |
| HCG cancer Centre, Vizag Visakhapatnam, | |
| Hoag Cancer Center Irvine, California | Leila Andres - (Leila.andres@hoag.org) Irma Hernandez - (Irma.Hernandez@hoag.org) |
| Houston Metro Urology Houston, Texas | |
| Inamdar Hospital Pune Pune, | |
| Indriyani Hospital & Cancer Institute Pune, Maharashtra | Dinesh Chaudhari, MBBS, MS - (drdineshoncosurgeon@gmail.com) |
| Integrated Medical Professionals New York, New York | Luis Leanez - (lleanez@manhattanmedicalresearch.com) |
| Jasleen Hospital Nagpur, | |
| KMC Manipal Nagar, | Shikha Parthan - (shikha.parthan@manipal.edu) |
| KR Hospital Mysuru, | |
| Kansas University Medical Center Kansas City, Kansas | |
| Karmanos Cancer Institute Detroit, Michigan | Alexandra Calcaterra - (CalcaterraA@Karmanos.org) |
| Kidney Centre Jasleen Hospital Nagpur, Maharashtra | Ravindra Deshmukh, MBBS,MS,DNB - (dravi962@gmail.com) |
| Lowcountry Urology Clinics North Charleston, South Carolina | Samara Grimes - (sgrimes@lcurology.com) |
| Memorial Healthcare System Pembroke Pines, Florida | Ines Padron - (IPadronCubillan@mhs.net) Melinda Garnello - (MGarnello@mhs.net) |
| MidLantic Urology Bala-Cynwyd, Pennsylvania | Kelly Liberatore - (kliberatore@midlanticurology.com) |
| Moffitt Cancer Center Tampa, Florida | |
| Muljibhai Patel Urological Hospital Gujrāt, | Ruhi Saiyad - (uro.research@mpuh.in) Ms. Manali Prajapati - (uro.research@mpuh.in) |
| NYU Langone Health New York, New York | Maelia Barry - (Maelia.Barry@nyulangone.org) Diana Castro - (Diana.Castro@nyulangone.org) |
| Northwestern University-Feinberg School of Medicine Chicago, Illinois | Claire Carter - (claire.carter@northwestern.edu) |
| Onco Life Cancer Center Pune, | Mr Rutvi - (rutvi@asiaccro.com) |
| Pi Health Cancer Hospital Hyderabad, Telangana | Venugopal Arroju, DM - (venugopal.arroju@picancerhospital.ai) |
| Potomac Urology Alexandria, Virginia | Morgan Gray - (mgray@potomacurology.com) Laura Mendoza - (lmendoza@potomacurology.com) |
| Premier Medical Group of the Hudson Valley Poughkeepsie, New York | Lisa Gray - (lgray@premiermedicalhv.com) |
| Rush University Chicago, Illinois | Amanda Abraham - (amanda_a_abraham@rush.edu) Karen Ohara - (karen_ohara@rush.edu) |
| SP Medical College and Hospital Bikaner, | Shekhar Goyal - (shekhar@siaramresearch.com) |
| Skyline Sherman Oaks Sherman Oaks, California | |
| Skyline Urology Torrance, California | |
| Specialty Clinical Research of St. Louis St Louis, Missouri | |
| Sunninghill Hospital Sandton, | Steve M Cornish, MD - (steven@drcornish.co.za) |
| Swami Harshankaranand JI Hospital and Research Centre Sunderpur, Varanasi | Deepak K Singh, MBBS, MS - (deepakbhu@gmail.com) |
| Texas Oncology Dallas, Texas | Silvia Lara - (silvia.lara@usoncology.com) |
| The Cleveland Clinic Foundation Cleveland, Ohio | Mikayla Baer - (baerm3@ccf.org) |
| The Urology Group Cincinnati, Ohio | Stacy Ranz, LPN - (sranz@urologygroup.com) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Alex Kolesnikov, MPH - (Oleksandr.Kolesnikov@jefferson.edu) |
| UCLA Department of Urology Los Angeles, California | |
| University of Alabama at Birmingham Birmingham, Alabama | |
| University of California San Diego La Jolla, California | Karen Cuervo - (kcuervo@health.ucsd.edu) |
| University of California, Davis Sacramento, California | |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| University of North Carolina Chapel Hill Chapel Hill, North Carolina | |
| University of Washington School of Medicine Seattle, Washington | |
| UroPartners Glenview, Illinois | Karolina Webb - (kwebb@uropartners.com) |
| Urocare Hospital Rajkot, | Mr Joyt - (trialnestlifesciences@gmail.com) |
| Urology Associates Nashville, Tennessee | |
| Urology Austin, PLLC, Research Department Austin, Texas | Rebecca Rodriguez - (rebecca.rodriguez@urologyaustin.com) |
| Urology Group of New Mexico (AccumetRx Clinical Research) Albuquerque, New Mexico | |
| Urology Partners of North Texas Arlington, Texas | |
| Urology San Antonio San Antonio, Texas | Manuel Hernandez - (manuel.hernandez@usa-clinicaltrials.com) Gavon Payne - (gavon.payne@usa-clinicaltrials.com) |
| Urology of Indiana Greenwood, Indiana | Brittiny Currin - (bcurrin@urologyin.com) Sarah Faisal - (sarah.faisal@us-uro.com) |
| Urology of Virginia Virginia Beach, Virginia | Ayanna Knight - (aknight@Urologyofva.net) |
| Uttar Pradesh University of Medical Sciences Uttar, | Suraj Singh - (suraj@helsinkiclinicalsolutions.in) |
| Virginia Commonwealth University Richmond, Virginia | Melanie Hamilton - (mrhamilton2@vcu.edu) |
| Virginia Urology Richmond, Virginia | Ewunik McCarthy - (eamccarthy@uro.com) Jordan Moore - (jnmoore@uro.com) |
| Winthrop University Hospital Mineola, New York |