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Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging (INDICATE)

Loney, Shenise - loneys2@vcu.edu

Urdaneta, Alfredo, I
NCT04423211
HM20021980
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Inclusion Criteria:
* STEP 0: REGISTRATION ELIGIBILITY CRITERIA * Patient must be male and \>= 18 years of age. * Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma * Patient must have biochemical recurrence (BCR) after RP, defined as follows: * If time to BCR, defined as time to first detectable PSA ( \> lower limit of normal for assay used) after RP, is \< 12 months, a minimum PSA level of \>= 0.2 ng/mL and a confirmatory reading of \>= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng/mL are eligible) * If time to BCR, defined as time to first detectable PSA (\> lower limit of normal for assay used) after RP, is \>= 12 months, a minimum absolute PSA of 0.5 ng/mL is required * If the patient has a detectable PSA (\> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum PSA requirement * Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET/CT or PET/MR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT/MRI for soft tissue lesions and/or a bone scan for osseous lesions * Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration * Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields. Baseline PET/CT or PET/MR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration * Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT) * 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 0-2 * Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET/CT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT. * Patient must not be enrolled in another therapeutic clinical trial * Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery * Patients undergoing a PET/MR must meet local institutional safety guidelines for MRI * Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration * Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy * Hemoglobin (Hgb) \>= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration) * Leukocytes \>= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration) * Absolute neutrophil count \>= 1,500/mcL (obtained within 8 weeks prior to Step 0 registration) * Platelets \>= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration) * Total bilirubin \< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, must have a direct bilirubin of \< 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration) * Creatine \< 1.5 x instituional ULN (or measured creatinine clearance \> 30 mL/min) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment) * Patient must not have completed a course of prior pelvic radiation therapy for any reason * Patient must agree not to father children while on study * Patient must be English or Spanish speaking to be eligible for the QOL component of the study * NOTE: Sites cannot translate the associated QOL forms * STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA * Patient must have completed a baseline SOC PET/CT or PET/MR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration * For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative) * For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields \[prostate bed +/- typical whole pelvis\]), the number of extra-pelvic lesions must be known (1 - 5 or \> 5 extra-pelvic lesions)
RADIATION: 3-Dimensional Conformal Radiation Therapy, DRUG: Apalutamide, PROCEDURE: Computed Tomography, DRUG: Degarelix, RADIATION: External Beam Radiation Therapy, OTHER: Fluciclovine F18, DRUG: Goserelin Acetate, PROCEDURE: Intensity-Modulated Proton Therapy, RADIATION: Intensity-Modulated Radiation Therapy, DRUG: Leuprolide Acetate, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, DRUG: Relugolix, RADIATION: Stereotactic Body Radiation Therapy, DRUG: Triptorelin, RADIATION: Volume Modulated Arc Therapy
Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
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Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
AdventHealth Littleton Littleton, Colorado
AdventHealth Parker Parker, Colorado
AdventHealth Porter Denver, Colorado
Alaska Breast Care and Surgery LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Oncology and Hematology LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Women's Cancer Care Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Immanuel Medical Center Omaha, Nebraska
Alegent Health Lakeside Hospital Omaha, Nebraska
Alton Memorial Hospital Alton, Illinois
Anchorage Associates in Radiation Medicine Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Anchorage Oncology Centre Anchorage, Alaska
Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Regional Cancer Center Wausau, Wisconsin
Audie L Murphy VA Hospital San Antonio, Texas
BASS Medical Group - Lennon Walnut Creek, California
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-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 Hospital Coos Bay, Oregon Site Public Contact - (cherie.cox@bayareahospital.org)
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bethesda North Hospital Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
CHI Health Good Samaritan Kearney, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Northwest - Spokane South Spokane, Washington Site Public Contact - (research@ccnw.net)
Cancer Care Northwest-North Spokane Spokane, Washington Site Public Contact - (research@ccnw.net)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.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)
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)
Carlisle Regional Cancer Center Carlisle, Pennsylvania Site Public Contact - (ecog.rss@jimmy.harvard.edu)
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
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
City of Hope Antelope Valley Lancaster, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Comprehensive Cancer Center Duarte, California Scott M. Glaser - (sglaser@coh.org)
City of Hope Corona Corona, California Site Public Contact - (becomingapatient@coh.org)
City of Hope South Pasadena South Pasadena, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Upland Upland, California Site Public Contact - (becomingapatient@coh.org)
Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Cooper Hospital University Medical Center Camden, New Jersey
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)
Crozer Regional Cancer Center at Brinton Lake Glen Mills, Pennsylvania
Crozer-Keystone Regional Cancer Center at Broomall Broomall, Pennsylvania
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware County Memorial Hospital Drexel Hill, Pennsylvania
Dillon Health Center/Shaw Cancer Center Dillon, Colorado
ECU Health Oncology Kenansville Kenansville, North Carolina
ECU Health Oncology Kinston Kinston, North Carolina Site Public Contact - (research@ecuhealth.org)
ECU Health Oncology Richlands Richlands, North Carolina
FHCC at Northwest Hospital Seattle, Washington
Fairbanks Memorial Hospital Fairbanks, Alaska
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fox Chase Cancer Center Philadelphia, Pennsylvania
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center East Norriton, Pennsylvania
Fox Chase Cancer Center Buckingham Furlong, Pennsylvania
Fred Hutchinson Cancer Center Seattle, Washington
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Great Falls Clinic Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Hackensack University Medical Center Hackensack, New Jersey
Health Partners Inc Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (Trisha.England2@mymlc.com)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Hi-Line Sletten Cancer Center Havre, Montana Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Idaho Urologic Institute-Meridian Meridian, Idaho
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Canton Canton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Macomb Macomb, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peru Peru, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Princeton Princeton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Jewish Hospital Louisville, Kentucky
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kadlec Clinic Hematology and Oncology Kennewick, Washington Site Public Contact - (research@kadlecmed.org)
Katmai Oncology Group Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Lake Regional Hospital Osage Beach, Missouri Site Public Contact - (clinicaltrials@lakeregional.com)
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Langlade Hospital and Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver, Washington
Legacy Good Samaritan Hospital and Medical Center Portland, Oregon
Legacy Meridian Park Hospital Tualatin, Oregon
Legacy Mount Hood Medical Center Gresham, Oregon
Legacy Salmon Creek Hospital Vancouver, Washington
Lenox Hill Hospital New York, New York
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Longmont United Hospital Longmont, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Los Angeles General Medical Center Los Angeles, California
Loyola University Medical Center Maywood, Illinois
MD Anderson Cancer Center at Cooper-Voorhees Voorhees Township, New Jersey
MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri
MaineHealth Cancer Care Center of York County Sanford, Maine
MaineHealth Cancer Care and IV Therapy - Sanford Sanford, Maine
MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine
MaineHealth Coastal Cancer Treatment Center Bath, Maine
MaineHealth Maine Medical Center - Biddeford Biddeford, Maine
MaineHealth Maine Medical Center - Portland Portland, Maine
MaineHealth Maine Medical Center- Scarborough Scarborough, Maine
Manhattan Eye Ear and Throat Hospital New York, New York
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Hospital of Carbondale Carbondale, Illinois Site Public Contact - (clinical.research@sih.net)
Memorial Hospital of Laramie County Cheyenne, Wyoming Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Mercy Cancer Center Merced, California
Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri
Mercy Cancer Center - Carmichael Carmichael, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Elk Grove Elk Grove, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Rocklin Rocklin, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Sacramento Sacramento, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Hospital Coon Rapids, Minnesota
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Fort Smith Fort Smith, Arkansas
Mercy Hospital Joplin Joplin, Missouri Site Public Contact - (esmeralda.carrillo@mercy.net)
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
Mercy Hospital Pittsburg Pittsburg, Kansas
Mercy Hospital Saint Louis St Louis, Missouri
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Hospital Springfield Springfield, Missouri
Mercy 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)
Minnesota Oncology - Burnsville Burnsville, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology - Coon Rapids Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology - Edina Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology - Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Chaska Chaska, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mission Hope Medical Oncology - Santa Maria Santa Maria, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Moffitt Cancer Center Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center - McKinley Campus Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center-International Plaza Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Einstein Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Weiler Hospital The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Monticello Cancer Center Monticello, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mount Sinai Chelsea New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Union Square New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai West New York, New York Site Public Contact - (CCTO@mssm.edu)
New York Proton Center New York, New York Site Public Contact - (ichoi@nyproton.com)
North Memorial Medical Health Center Robbinsdale, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Northwell Health Imbert Cancer Center Bay Shore, New York
Northwell Health Physicians Partners Radiation Medicine at Queens Forest Hills, New York
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Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
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Northwestern Medicine Oak Brook Oak Brook, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
OSF Saint Anthony's Health Center Alton, Illinois
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)
Our Lady of the Lake Physician Group Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.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)
Parkland Health Center - Farmington Farmington, Missouri
Parkland Memorial Hospital Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
PeaceHealth Saint John Medical Center Longview, Washington Site Public Contact - (kmakin-bond@peacehealth.org)
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PeaceHealth United General Medical Center Sedro-Woolley, Washington Site Public Contact - (achapman1@peacehealth.org)
Penn Presbyterian Medical Center Philadelphia, Pennsylvania Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu)
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Penrose-Saint Francis Healthcare Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Phelps Health Delbert Day Cancer Institute Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
Phelps Memorial Hospital Center Sleepy Hollow, New York
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Cancer Institute Clackamas Clinic Clackamas, Oregon
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 Regional Cancer Partnership Everett, Washington Site Public Contact - (marilyn.birchman@providence.org)
Providence Regional Cancer System-Aberdeen Aberdeen, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Centralia Centralia, Washington Site Public Contact - (deidre.dillon@providence.org)
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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)
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Queens Cancer Center Rego Park, New York
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Robert Wood Johnson University Hospital Somerset Somerville, New Jersey Site Public Contact - (Siby.Varughese@rwjbh.org)
Rocky Mountain Cancer Centers-Aurora Aurora, Colorado
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Rocky Mountain Cancer Centers-Thornton Thornton, Colorado
Rush MD Anderson Cancer Center Chicago, Illinois Site Public Contact - (Cancer_Studies@rush.edu)
Rush MD Anderson Cancer Center at Rush Lisle Lisle, Illinois Site Public Contact - (Cancer_Studies@rush.edu)
Rush MD Anderson Cancer Center at Rush Oak Park Oak Park, Illinois Site Public Contact - (Cancer_Studies@rush.edu)
Rush-Copley Medical Center Aurora, Illinois Site Public Contact - (RCMC_Cancer_Research@rush.edu)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
SIH Cancer Institute Carterville, Illinois Site Public Contact - (clinical.research@sih.net)
SSM Health Good Samaritan Mount Vernon, Illinois Site Public Contact - (gayla.hall@ssmhealth.com)
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho
Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho
Saint Anthony Hospital Lakewood, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Anthony North Hospital Westminster, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Charles Health System Bend, Oregon Site Public Contact - (nosall@stcharleshealthcare.org)
Saint Francis Cancer Center Greenville, South Carolina Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint Francis Regional Medical Center Shakopee, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint 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 Radiation Oncology Resource Center Lexington, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Joseph's Medical Center Stockton, California
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)
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Saint Mary Corwin Medical Center Pueblo, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Mary's Hospital West Palm Beach, Florida
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De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA) (DEBRA)

Director Department of Regulatory Affairs - langerj@nrgoncology.org

Adams, Todd, C
NCT04852887
HM20023504
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Inclusion Criteria:
* • The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry/Step 1 and, for patients treated in the U.S., authorization permitting release of personal health information. * The patient must have an ECOG performance status of 0 or 1. * The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional resection.) * The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination. * Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection). * The following staging criteria must be met postoperatively according to AJCC 8th edition criteria: * By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm). * By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.) * Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen. \*\* For patients with a T1a tumor (less than or equal to 0.5 cm in size) or patients at Canadian provinces or approved international sites where Oncotype DX Recurrence Score testing would not be covered, who do not already have an Oncotype DX Recurrence Score at pre-entry/Step 1, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory. Tumor size sample must be greater than or equal to 0.2 cm for analysis. \*\*\* The Oncotype RS can be run on the biopsy core or surgical specimen. The patient cannot have initiated endocrine therapy prior to tissue collection. * An Oncotype RS is required for eligibility, however, for a patient whose tumor has already had a MammaPrint test completed as part of usual care when being considered for enrollment and is in the binary "Low" category will meet this eligibility criteria and an Oncotype RS does not need to be performed. * The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive. * The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines. * Patients may be premenopausal or postmenopausal at the time of pre-entry/Step 1. For study purposes, postmenopausal is defined as: * Age 56 or older with no spontaneous menses for at least 12 months prior to pre-entry/Step 1; or a documented hysterectomy; or * Age 55 or younger with no spontaneous menses for at least 12 months prior to pre-entry/Step 1 (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or Documented bilateral oophorectomy. * The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry/Step 1 must be no more than 70 days. * The patient must have recovered from surgery with the incision completely healed and no signs of infection. * Bilateral mammogram or MRI within 6 months prior to pre-entry/Step 1. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion.
Exclusion Criteria:
* • Definitive clinical or radiologic evidence of metastatic disease. * pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer. * Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease. * Patient had a mastectomy. * Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor. * Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign. * Non-epithelial breast malignancies such as sarcoma or lymphoma. * Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.) * Paget's disease of the nipple. * Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible.) * Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.) * Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible.) * Treatment plan that includes regional nodal irradiation. * Any treatment with radiation therapy, chemotherapy, or biotherapy, administered for the currently diagnosed breast cancer prior to pre-entry/Step 1. * History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to pre-entry/Step 1. * Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. \*\* Patients are eligible for BR007 if they receive a short course of preoperative endocrine therapy of less than 6 weeks duration (prior to randomization/Step 2) for this diagnosis after the core biopsy (and can continue postoperatively if: * the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18, AND * the patient had not initiated endocrine therapy prior to core biopsy tissue collection. \*\*\* This does not apply to adjuvant endocrine therapy recommended for this diagnosis which may start any time after surgery including prior to registration (Pre-entry/Step 1). * Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible. Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible. * Prior breast or thoracic RT for any condition. * Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. * Pregnancy or lactation at the time of pre-entry/Step 1 or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry/Step 1.) * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications. * Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results. * Use of any investigational product within 30 days prior to pre-entry/Step 1.
OTHER: Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane), DRUG: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
Stage I Breast Cancer
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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)
Adams Cancer Center Gettysburg, Pennsylvania
AdventHealth Altamonte Altamonte Springs, Florida
AdventHealth Littleton Littleton, Colorado
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
AdventHealth Parker Parker, Colorado
AdventHealth Porter Denver, Colorado
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 Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
Allan Blair Cancer Centre Regina, Saskatchewan
Allegheny General Hospital Pittsburgh, Pennsylvania
Allegheny Valley Hospital Natrona Heights, Pennsylvania Site Public Contact - (Dawnmarie.DeFazio@ahn.org)
Allegiance Health Jackson, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Alton Memorial Hospital Alton, Illinois
Altru Cancer Center Grand Forks, North Dakota
American Fork Hospital / Huntsman Intermountain Cancer Center American Fork, Utah Site Public Contact - (officeofresearch@imail.org)
Armes Family Cancer Center Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Arnot Ogden Medical Center/Falck Cancer Center Elmira, New York
Ascension Via Christi Hospitals Wichita Wichita, Kansas Site Public Contact - (research@viachristi.org)
Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Medford Hospital Medford, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Regional Cancer Center Wausau, Wisconsin
Asplundh Cancer Pavilion Willow Grove, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John, New Brunswick
Atrium Health Cabarrus/LCI-Concord Concord, North Carolina
Atrium Health Cleveland/LCI-Cleveland Shelby, North Carolina
Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina
Atrium Health Stanly/LCI-Albemarle Albemarle, North Carolina
Atrium Health Union/LCI-Union Monroe, North Carolina
Atrium Health University City/LCI-University Charlotte, North Carolina
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
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 Health Center-Fond du Lac Fond du Lac, 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 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
Bay Area Breast Surgeons Inc Emeryville, California
Bay Area Tumor Institute Oakland, California
Beacon Kalamazoo Kalamazoo, Michigan
Beaufort Memorial/New River Cancer Center Okatie, South Carolina
Beebe Health Campus Rehoboth Beach, Delaware
Beebe Medical Center Lewes, Delaware
Beebe South Coastal Health Campus Millville, Delaware
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)
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 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)
Boston Medical Center Boston, Massachusetts
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Broadlawns Medical Center Des Moines, Iowa
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)
Brooke Army Medical Center Fort Sam Houston, Texas
CHI Health Good Samaritan Kearney, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Québec, Quebec Site Public Contact - (rechclinique@crchuq.ulaval.ca)
CHUM - Centre Hospitalier de l'Universite de Montreal Montreal, Quebec Site Public Contact - (info.cr.chum@ssss.gouv.qc.ca)
California Pacific Medical Center-Pacific Campus San Francisco, California Site Public Contact - (clinicalresearch@sutterhealth.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 Care and Hematology-Fort Collins Fort Collins, Colorado Site Public Contact - (Roster@nrgoncology.org)
Cancer Center at Saint Joseph's Phoenix, Arizona Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Center of Kansas - Salina Salina, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Wichita Wichita, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer Partners of Nebraska Lincoln, Nebraska Site Public Contact - (research@cancerpartners.com)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Capital Health Medical Center-Hopewell Pennington, New Jersey Site Public Contact - (clinicaltrials@capitalhealth.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)
Caro Cancer Center Caro, Michigan
Carolina Regional Cancer Center Myrtle Beach, South Carolina
CarolinaEast Medical Center New Bern, North Carolina Site Public Contact - (lharrison@carolinaeasthealth.com)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Castle Medical Center Kailua, Hawaii
Cedars Sinai Medical Center Los Angeles, California
Cedars-Sinai Cancer - Tarzana Tarzana, California
Central Maryland Radiation Oncology in Howard County Columbia, Maryland
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Chambersburg Hospital Chambersburg, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Chilton Medical Center Pompton, New Jersey
Christiana Care Health System-Christiana Hospital Newark, Delaware
Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania
Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Cleveland Clinic Akron General Akron, Ohio Site Public Contact - (CancerAnswer@ccf.org)
Cleveland Clinic Cancer Center Mansfield Mansfield, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Cancer Center Strongsville Strongsville, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Foundation Cleveland, Ohio
Cleveland Clinic Mercy Hospital Canton, Ohio
Cleveland Clinic Wooster Family Health and Surgery Center Wooster, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic-Weston Weston, Florida Site Public Contact - (CancerAnswer@ccf.org)
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
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)
Condell Memorial Hospital Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Contra Costa Regional Medical Center Martinez, California
Corewell Health Beaumont Troy Hospital Troy, Michigan
Corewell Health Farmington Hills Hospital Farmington Hills, Michigan
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 William Beaumont University Hospital Royal Oak, Michigan
CoxHealth South Hospital Springfield, Missouri
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Crozer Regional Cancer Center at Brinton Lake Glen Mills, Pennsylvania
Crozer-Keystone Regional Cancer Center at Broomall Broomall, Pennsylvania
Dartmouth Cancer Center - North Saint Johnsbury, Vermont Site Public Contact - (cancer.research.nurse@hitchcock.org)
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Physician LLC - Englewood Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC - Troy Troy, Ohio
Dayton Physicians LLC-Atrium Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Miami Valley South Centerville, Ohio
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware Clinical and Laboratory Physicians PA Newark, Delaware
Delaware Health Center-Grady Cancer Center Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Dillon Health Center/Shaw Cancer Center Dillon, Colorado
Doctor's Hospital of Laredo Laredo, Texas
Doctors Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Dominican Santa Cruz Hospital Santa Cruz, California
Drexel Town Square Health Center Oak Creek, Wisconsin
Dublin Methodist Hospital Dublin, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
Edward Hospital/Cancer Center Naperville, Illinois
Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois Site Public Contact - (Cancerresearch@edward.org)
Edwards Comprehensive Cancer Center Huntington, West Virginia Site Public Contact - (Christina.Cole@chhi.org)
Ehime University Hospital Ehime,
Elmhurst Memorial Hospital Elmhurst, Illinois Site Public Contact - (Jrohde@emhc.org)
Emory Decatur Hospital Decatur, Georgia Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org)
Emory Johns Creek Hospital Johns Creek, Georgia Site Public Contact - (m.lisa.hwang@emory.edu)
Emory Saint Joseph's Hospital Atlanta, Georgia
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Ephrata Cancer Center Ephrata, Pennsylvania
Epic Care Partners in Cancer Care Emeryville, California
Epic Care-Dublin Dublin, California
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Ridges Hospital Burnsville, Minnesota
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
First Physicians Group - Silverstein Institute at Floyd Street Sarasota, Florida Site Public Contact - (researchinstitute@smh.com)
First Physicians Group - Urology Robotic and Minimally Invasive Surgery Sarasota, Florida
First Physicians Group-Sarasota Sarasota, Florida
Florida Cancer Specialists - Bradenton Cancer Center Bradenton, Florida Site Public Contact - (clinicaltrials@flcancer.com)
Florida Cancer Specialists - Sarasota Sarasota, Florida Site Public Contact - (Roster@nrgoncology.org)
Florida Cancer Specialists - Sarasota Downtown Sarasota, Florida
Florida Cancer Specialists - Venice Island Venice, Florida Site Public Contact - (Roster@nrgoncology.org)
Florida Cancer Specialists - Venice Pinebrook Venice, Florida Site Public Contact - (ClinicalTrials@FLCancer.com)
Forbes Hospital Monroeville, Pennsylvania
Fox Chase Cancer Center Philadelphia, Pennsylvania
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center East Norriton, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Fox Chase Cancer Center Buckingham Furlong, Pennsylvania
Franciscan Health Indianapolis Indianapolis, Indiana
Franciscan Health Mooresville Mooresville, Indiana
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Fresno Cancer Center Fresno, California Site Public Contact - (Kpoct@kp.org)
Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin
Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin
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 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)
Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California
Genesis Healthcare System Cancer Care Center Zanesville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
GenesisCare USA - Aventura Aventura, Florida
GenesisCare USA - Aventura FP Aventura, Florida
GenesisCare USA - Plantation Plantation, Florida
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
Grady Memorial Hospital Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Grand View Hospital Sellersville, Pennsylvania
Grant Medical Center Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Greater Baltimore Medical Center Baltimore, Maryland
Greater Dayton Cancer Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Greater Regional Medical Center Creston, Iowa
Gulfport Memorial Hospital Gulfport, Mississippi Site Public Contact - (emede1@lsuhsc.edu)
Gunma University Hospital Gunma,
Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania
HSHS Sacred Heart Hospital Eau Claire, Wisconsin
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Hawaii Cancer Care - Westridge ‘Aiea, Hawaii Site Public Contact - (info@hawaiicancercare.com)
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii Site Public Contact - (i.webster@hawaiicancercare.com)
Hawaii Cancer Care Inc-Liliha Honolulu, Hawaii
Hayworth Cancer Center High Point, North Carolina
Health Central Ocoee, Florida Site Public Contact - (Roster@nrgoncology.org)
Health Partners Inc Minneapolis, Minnesota
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (Trisha.England2@mymlc.com)
Helen F Graham Cancer Center Newark, Delaware
Hematology Oncology Associates of CNY at Camillus Camillus, New York
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York
Hendrick Medical Center Abilene, Texas
Henry Ford Cancer Institute-Downriver Brownstown, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Health Saint John Hospital Detroit, Michigan Site Public Contact - (Kkeenan1@hfhs.org)
Henry Ford Health Warren Hospital Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Hospital Detroit, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Medical Center-Columbus Novi, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Medical Center-Fairlane Dearborn, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Wyandotte Hospital Wyandotte, Michigan Site Public Contact - (nhay@hfhs.org)
Highland Hospital Rochester, New York
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Hiroshima University Hospital Hiroshima,
Hokkaido University Hospital Hokkaido, Site Public Contact - (hassi@med.hokudai.ac.jp)
Holy Name Hospital Teaneck, New Jersey
Hope Women's Cancer Centers-Asheville Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.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 - (Roster@nrgoncology.org)
Houston Methodist San Jacinto Hospital Baytown, Texas Site Public Contact - (Roster@nrgoncology.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
Huntington Memorial Hospital Pasadena, California
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Hyogo Cancer Center Akashi, Hyōgo
IU Health Methodist Hospital Indianapolis, Indiana
IU Health North Hospital Carmel, Indiana
IU Health West Hospital Avon, Indiana
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-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 Site Public Contact - (clinical.trials@daytonncorp.org)
Ingalls Memorial Hospital Harvey, Illinois Site Public Contact - (clinicaltrials@ingalls.org)
Intercoastal Medical Group - Cattleridge II Sarasota, Florida
Intermountain Medical Center Murray, Utah Site Public Contact - (officeofresearch@imail.org)
Iowa Methodist Medical Center Des Moines, Iowa
Jefferson Hospital Jefferson Hills, Pennsylvania Site Public Contact - (ddefazio@wpahs.org)
Jefferson Torresdale Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
John H Stroger Jr Hospital of Cook County Chicago, Illinois
Kaiser Permanente - Largo Medical Center Largo, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente Cancer Treatment Center South San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Downtown Commons Sacramento, California Site Public Contact - (kpoct@kp.org)
Kaiser Permanente Dublin Dublin, California
Kaiser Permanente Fresno Orchard Plaza Fresno, California
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Lutherville - Timonium Medical Center Lutherville, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Medical Center-Vacaville Vacaville, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii Site Public Contact - (shelley.a.clark@kp.org)
Kaiser Permanente Northwest Portland, Oregon
Kaiser Permanente Oakland-Broadway Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente San Leandro San Leandro, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente- Marshall Medical Offices Redwood City, California
Kaiser Permanente- Modesto MOB II Modesto, California
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Deer Valley Medical Center Antioch, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fremont Fremont, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fresno Fresno, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Modesto Modesto, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Richmond Richmond, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Riverside Riverside, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Roseville Roseville, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Francisco San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Santa Rosa Santa Rosa, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Santa Teresa-San Jose San Jose, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South Sacramento Sacramento, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South San Francisco South San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Stockton Stockton, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Vallejo Vallejo, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Walnut Creek Walnut Creek, California Site Public Contact - (Kpoct@kp.org)
Kaiser San Rafael-Gallinas San Rafael, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Karmanos Cancer Institute at McLaren Greater Lansing Lansing, Michigan Site Public Contact - (ctoadmin@karmanos.org)
Kent Hospital Warwick, Rhode Island
Kettering Medical Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Kindai University Osaka,
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Kingston Health Sciences Centre Kingston, Ontario Site Public Contact - (cc-clinicaltrials@kgh.kari.net)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kuakini Medical Center Honolulu, Hawaii
Kyoto University Hospital Kyoto,
LDS Hospital Salt Lake City, Utah Site Public Contact - (officeofresearch@imail.org)
LSU Health Sciences Center at Shreveport Shreveport, Louisiana Site Public Contact - (LPost@lsuhsc.edu)
Lafayette Family Cancer Center-EMMC Brewer, Maine
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Langlade Hospital and Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver, Washington Site Public Contact - (oncologyresearch@lhs.org)
Legacy Good Samaritan Hospital and Medical Center Portland, Oregon Site Public Contact - (cancer@lhs.org)
Legacy Meridian Park Hospital Tualatin, Oregon
Legacy Mount Hood Medical Center Gresham, Oregon
Legacy Salmon Creek Hospital Vancouver, Washington
Lenox Hill Hospital New York, New York
Levine Cancer Institute - Rutherford Forest City, North Carolina
Levine Cancer Institute - Union West Matthews, North Carolina
Levine Cancer Institute-Ballantyne Charlotte, North Carolina
Levine Cancer Institute-Rock Hill Rock Hill, South Carolina
Levine Cancer Institute-SouthPark Charlotte, North Carolina
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia Site Public Contact - (underberga@sjchs.org)
Logan Regional Hospital Logan, Utah Site Public Contact - (officeofresearch@imail.org)
Longmont United Hospital Longmont, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.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)
Lourdes Hospital Binghamton, New York
Lowell General Hospital Lowell, Massachusetts
Loyola University Medical Center Maywood, Illinois
Lutheran Hospital - Cancer Centers of Colorado Golden, Colorado Site Public Contact - (peaksresearch@imail.org)
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson League City League City, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson West Houston Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson in Sugar Land Sugar Land, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson in The Woodlands Conroe, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri
MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri
Manhattan Eye Ear and Throat Hospital New York, New York
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina Site Public Contact - (pardeecancerresearch@unchealth.unc.edu)
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-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
Mary Imogene Bassett Hospital Cooperstown, New York Site Public Contact - (CancerClinicalTrials@bassett.org)
Matthews Radiation Oncology Center Matthews, North Carolina Site Public Contact - (kashah@novanthealth.org)
Mayo Clinic Health System in Albert Lea Albert Lea, Minnesota
Mayo Clinic Health System-Franciscan Healthcare La Crosse, Wisconsin
Mayo Clinic Health Systems-Mankato Mankato, Minnesota
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
McKay-Dee Hospital Center Ogden, Utah Site Public Contact - (officeofresearch@imail.org)
McLaren Cancer Institute-Bay City Bay City, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Central Michigan Mount Pleasant, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Clarkston Clarkston, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Flint Flint, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Lapeer Region Lapeer, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Macomb Mount Clemens, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Northern Michigan Petoskey, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren-Port Huron Port Huron, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLeod Regional Medical Center Florence, South Carolina Site Public Contact - (dorie.sturgill@mcleodhealth.org)
MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore, Maryland
MedStar Georgetown University Hospital Washington D.C., District of Columbia
MedStar Good Samaritan Hospital Baltimore, Maryland Site Public Contact - (Barbara.rector@medstar.net)
MedStar Health Bel Air Medical Campus Bel Air, Maryland Site Public Contact - (David.j.perry2@medstar.net)
Medical Center of the Rockies Loveland, Colorado
Medical College of Wisconsin Milwaukee, Wisconsin
Medical Oncology Hematology Consultants PA Newark, Delaware
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
Memorial Hospital of Carbondale Carbondale, Illinois Site Public Contact - (clinical.research@sih.net)
Memorial Medical Center Springfield, Illinois Site Public Contact - (clinicalresearch@sutterhealth.org)
Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey
Memorial Sloan Kettering Bergen Montvale, New Jersey
Memorial Sloan Kettering Cancer Center New York, New York
Memorial Sloan Kettering Commack Commack, New York
Memorial Sloan Kettering Monmouth Middletown, New Jersey
Memorial Sloan Kettering Nassau Uniondale, New York
Memorial Sloan Kettering Westchester Harrison, New York
Mercy Cancer Center - 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 Fitzgerald Hospital Darby, Pennsylvania
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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-Rockville Center Rockville Centre, New York
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 Willowbrook Hospital Houston, Texas Site Public Contact - (Roster@nrgoncology.org)
MetroHealth Medical Center Cleveland, Ohio Site Public Contact - (ababal@metrohealth.org)
Miami Valley Cancer Care and Infusion Greenville, Ohio
Miami Valley Hospital Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital North Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Michigan Healthcare Professionals Clarkston Clarkston, Michigan Site Public Contact - (rudi.ross@profoundresearch.io)
Michigan Healthcare Professionals Farmington Farmington Hills, Michigan Site Public Contact - (rudi.ross@profoundresearch.io)
Michigan Healthcare Professionals Macomb Macomb, Michigan Site Public Contact - (rudi.ross@profoundresearch.io)
Michigan Healthcare Professionals Madison Heights Madison Heights, Michigan Site Public Contact - (rudi.ross@profoundresearch.io)
Michigan Healthcare Professionals Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Michigan Healthcare Professionals Troy Troy, Michigan Site Public Contact - (rudi.ross@profoundresearch.io)
Midwestern Regional Medical Center Zion, Illinois
Minnesota Oncology - Burnsville Burnsville, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mission Hope Medical Oncology - Santa Maria Santa Maria, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Montefiore Medical Center - Moses Campus The Bronx, New York
Montefiore Medical Center-Einstein Campus The Bronx, New York
Montefiore Medical Center-Weiler Hospital The Bronx, New York
Monticello Cancer Center Monticello, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Morristown Medical Center Morristown, New Jersey
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)
Mount Carmel Health Center West Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Carmel New Albany Surgical Hospital New Albany, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Sinai Chelsea New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Comprehensive Cancer Center at Aventura Aventura, Florida Site Public Contact - (yenrique@msmc.com)
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Medical Center Miami Beach, Florida Site Public Contact - (yenrique@msmc.com)
Mount Sinai Queens Astoria, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Union Square New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai West New York, New York Site Public Contact - (CCTO@mssm.edu)
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)
NYU Langone Hospital - Brooklyn Brooklyn, New York Site Public Contact - (david.wallach@nyulangone.org)
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nagoya University Hospital Nagoya,
National Cancer Center Hospital Tokyo, Site Public Contact - (www-admin@ncc.go.jp)
Naval Medical Center - Portsmouth Portsmouth, Virginia
Nebraska Medicine-Bellevue Bellevue, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
Nebraska Medicine-Village Pointe Omaha, Nebraska
New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire
North Coast Cancer Care Sandusky, Ohio
North Memorial Medical Health Center Robbinsdale, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Northeast Radiation Oncology Center Dunmore, Pennsylvania
Northern Westchester Hospital Mount Kisco, New York Site Public Contact - (AMellor@northwell.edu)
Northside Hospital Atlanta, Georgia Site Public Contact - (ClinicalTrials@northside.com)
Northside Hospital-Alpharetta Alpharetta, Georgia Site Public Contact - (clinical.trials@northside.com)
Northside Hospital-Cherokee Canton, Georgia Site Public Contact - (clinical.trials@northside.com)
Northside Hospital-Forsyth Cumming, Georgia Site Public Contact - (clinicaltrials@northside.com)
Northwell Health Cancer Institute at Huntington Greenlawn, New York
Northwell Health Imbert Cancer Center Bay Shore, New York
Northwell Health/Center for Advanced Medicine Lake Success, New York
Northwest Cancer Center - Hobart Hobart, Indiana
Northwest Cancer Center - Main Campus Crown Point, Indiana
Northwest Cancer Center - Valparaiso Valparaiso, Indiana Site Public Contact - (CancerResearch@COMHS.org)
Northwest Oncology LLC Dyer, Indiana
Northwestern Medicine Cancer Center Delnor Geneva, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Glenview Outpatient Center Glenview, Illinois
Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois Site Public Contact - (cancertrials@northwestern.edu)
Northwestern Medicine Orland Park Orland Park, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Novant Health Cancer Institute - Huntersville Huntersville, North Carolina Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Kernersville Kernersville, North Carolina Site Public Contact - (asmarrs@novanthealth.org)
Novant Health Cancer Institute - Matthews Matthews, North Carolina Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Mooresville Mooresville, North Carolina Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Mount Airy Mount Airy, North Carolina Site Public Contact - (asmarrs@novanthealth.org)
Novant Health Cancer Institute - Rowan Salisbury, North Carolina Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Statesville Stateville, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Cancer Institute - Thomasville Thomasville, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Cancer Institute - Wilkesboro North Wilkesboro, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Forsyth Medical Center Winston-Salem, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Presbyterian Medical Center Charlotte, North Carolina Site Public Contact - (kashah@novanthealth.org)
OSF Saint Francis Medical Center Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
OSF Saint Joseph Medical Center Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Ochsner Hematology Oncology North Shore - Covington (West Region) Covington, Louisiana
Ochsner LSU Health - Cancer Treatment Center Shreveport, Louisiana
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
OhioHealth Mansfield Hospital Mansfield, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
OhioHealth Marion General Hospital Marion, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
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 MountainView Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Seven Hills Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oregon Health and Science University Portland, Oregon
Orion Cancer Care Findlay, Ohio
Orlando Health Cancer Institute Orlando, Florida Site Public Contact - (CancerClinicalTrials@orlandohealth.com)
Overlook Hospital Summit, New Jersey
PCR Oncology Arroyo Grande, California Site Public Contact - (research@sncrf.org)
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Pali Momi Medical Center ‘Aiea, Hawaii
Palo Alto Medical Foundation Health Care Palo Alto, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Camino Division Mountain View, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Fremont Fremont, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Santa Cruz Santa Cruz, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Pamela Youde Nethersole Eastern Hospital Hong Kong,
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Health Center - Farmington Farmington, Missouri
PeaceHealth Saint Joseph Medical Center Bellingham, Washington Site Public Contact - (achapman1@peacehealth.org)
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Penrose-Saint Francis Healthcare Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Phelps Health Delbert Day Cancer Institute Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
Phelps Memorial Hospital Center Sleepy Hollow, New York
Piedmont Fayette Hospital Fayetteville, Georgia Site Public Contact - (Roster@nrgoncology.org)
Piedmont Henry Hospital Stockbridge, Georgia
Piedmont Hospital Atlanta, Georgia Site Public Contact - (ORS@piedmont.org)
Piedmont Newnan Hospital Newnan, Georgia Site Public Contact - (ors@piedmont.org)
Pluta Cancer Center Rochester, New York Site Public Contact - (Roster@nrgoncology.org)
Poudre Valley Hospital Fort Collins, Colorado
Premier Blood and Cancer Center Dayton, Ohio
ProHealth D N Greenwald Center Mukwonago, Wisconsin Site Public Contact - (research.institute@phci.org)
ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin
ProMedica Flower Hospital Sylvania, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Cancer Institute Clackamas Clinic Clackamas, Oregon
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 Cancer Center - Pearlridge ‘Aiea, Hawaii
Queen's Medical Center Honolulu, Hawaii
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Rapid City Regional Hospital Rapid City, South Dakota
Reading Hospital McGlinn Cancer Institute at Phoenixville Phoenixville, Pennsylvania
Regional Cancer Center-Lee Memorial Health System Fort Myers, Florida Site Public Contact - (Roster@nrgoncology.org)
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Reid Health Richmond, Indiana Site Public Contact - (clinical.trials@daytonncorp.org)
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Rhode Island Hospital Providence, Rhode Island
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Ridley-Tree Cancer Center Santa Barbara, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Riverside Methodist Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
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Rock Hill Radiation Therapy Center Rock Hill, South Carolina
Rocky Mountain Cancer Centers-Boulder Boulder, Colorado
Rohnert Park Cancer Center Rohnert Park, California Site Public Contact - (Kpoct@kp.org)
Rose Medical Center Denver, Colorado Site Public Contact - (ccrp@co-cancerresearch.org)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
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UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado
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UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa
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UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland
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Cardiac Outcomes With Near-Complete Estrogen Deprivation (CROWN)

Sarah Hatcher, MPH - sarah.hatcher@duke.edu

Jordan, Jennifer
NCT05309655
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Inclusion Criteria * Women age ≤55 who were premenopausal at the time of breast cancer diagnosis; (Premenopausal is defined as per NCCN criteria). * Planned breast cancer treatment with NCED (near-complete estrogen deprivation) therapy that includes aromatase inhibitor therapy (or SERD) with medically or surgically induced menopause within three (3) months of initiating NCED (HR-positive tumor) or, for the cohorts not receiving NCED therapy, within three (3) months of planned chemotherapy, surgery or radiation. Index date for three months is defined as final date of treatment with chemotherapy, surgery or radiation which ever happens last (HR-negative tumor). Treatment with a Gonadotropin Releasing Hormone (GnRH) agonist for fertility preservation during chemotherapy is allowed and is not considered part of the NCED antineoplastic therapy. * Women with human epidermal growth factor-2 (HER2) negative and women with human epidermal growth factor-2 (HER2) positive breast cancer are eligible. * Treatment with CDK-inhibitor, PARP inhibitor immunotherapy or biologic (non-chemotherapy) agent as part of anti-neoplastic treatment plan is allowed. These agents are not considered chemotherapy. * Treatment with selective-estrogen receptor degrader (SERD) rather than aromatase inhibitor is allowed. * Diagnosed with Stage I-III breast cancer. * ECOG performance status of 0-2 * Patients with concurrent malignancies are eligible as long as therapies and disease course for these are reasonably expected to not impact cardiovascular function. (Examples of eligible malignancies include: papillary/follicular thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in-situ and early stage cervical cancers, etc.). * Patients with prior COVID-19 are eligible if they have recovered from the illness and are free of COVID-related symptoms other than allowable persistent symptoms: loss of taste and smell and/or grade 1 fatigue. * Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative). * The study will allow up to 30% of patients with MRI non-compatible breast expanders recognizing that baseline CMR will be outside of imaging window. Note: Registration of these participants will require study PI approval (Dr. Jordan or Dr. Thomas).
Exclusion Criteria:
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to adenosine * Active wheezing. * Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices, or some breast expanders. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study. Because some methods of birth control are not 100% reliable, a pregnancy test is required, unless the patient has undergone either a bilateral oophorectomy, hysterectomy or both. * Coronary revascularization in the past 6 months or known severe multi-vessel coronary artery disease previously determined to be not amendable to mechanical intervention. * Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring immediate cardiac catheterization * Allergy or prior sensitivity to gadolinium or other contrasting agents or their excipients. * Men with breast cancer. * Known chronic renal insufficiency or chronic electrolyte abnormalities as determined by the treating physician.
DRUG: Adenosine Stress Cardiac Magnetic Resonance Imaging, DIAGNOSTIC_TEST: Electrocardiogram, DIAGNOSTIC_TEST: Computed Tomography Angiogram, OTHER: Laboratory Testing, BEHAVIORAL: Quality of Life Survey
Breast Cancer, Triple Negative Breast Cancer, Cardiovascular Complications
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Study Locations

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Location Contacts
Duke Cancer Center Durham, North Carolina Sarah Hatcher, MPH - (sarah.hatcher@duke.edu)
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia Nicole Kaopua - (Kaopuakn@vcu.edu)
Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, North Carolina Sarah Hatcher, MPH - (sarah.hatcher@duke.edu)

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR)

Edwards TMTT Clinical Affairs - TMTT_Clinical@edwards.com

Gertz, Zachary
NCT04097145
HM20023593
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Inclusion Criteria:
* Eighteen (18) years of age or older * Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. * Severe or greater tricuspid regurgitation * New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months * Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team * Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
Exclusion Criteria:
* Tricuspid valve anatomy not evaluable by TTE or TEE * Tricuspid valve anatomy precludes proper device deployment and function * Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure) * Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:
• Would prevent proper TR reduction due to interaction of the lead with the leaflets
• Were implanted in the RV within the last 90 days prior to the point of enrollment * Primary non-degenerative tricuspid disease * Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL * Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction * Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment * Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days * Recent Stroke * Active gastrointestinal (GI) bleeding * Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease, including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenic RV * Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days * Any of the following cardiovascular procedures:
• Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment
• Carotid surgery within 30 days prior to the point of enrollment
• Direct current cardioversion within the last 30 days prior to the point of enrollment
• Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment
• Cardiac surgery within 90 days prior to the point of enrollment * Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation * Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis * Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days * Patient is oxygen-dependent or requires continuous home oxygen * Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days) * Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator * Patient is currently participating in another investigational biologic, drug, or device clinical study * Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship * Any patient considered to be vulnerable
DEVICE: Edwards PASCAL System, DRUG: Optimal Medical Therapy, DEVICE: Edwards PASCAL System, DEVICE: Edwards PASCAL System
Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
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Study Locations

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Location Contacts
Ascension St. Vincent Heart Center Cardiovascular Research Institute Indianapolis, Indiana
Banner University Medical Center Phoenix Phoenix, Arizona
Baylor College of Medicine St. Luke's Medical Center Houston, Texas
Baylor Scott & White - The Heart Hospital - Plano Plano, Texas
Carilion Medical Center Roanoke, Virginia
Cedars Sinai Medical Center Los Angeles, California
Columbia University Irving Medical Center/NYPH New York, New York
Cooper Health Systems Camden, New Jersey
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire
Emory University Hospital Midtown / Emory University - St. Joseph's Hospital Atlanta, Georgia
Erlanger Health System Chattanooga, Tennessee
Fairview Health Services Saint Paul, Minnesota
HCA Houston Healthcare Medical Center Houston, Texas
Hamilton Health Services Hamilton, Ontario
Henry Ford Hospital Detroit, Michigan
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Québec, Quebec
Integris Baptist Medical Center Oklahoma City, Oklahoma
Intermountain Medical Center Murray, Utah
Johns Hopkins Baltimore, Maryland
Kaiser Permanente San Francisco San Francisco, California
Lankenau Heart Institute Wynnewood, Pennsylvania
Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset New York, New York
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic Rochester, Minnesota
Medical Center of the Rockies Loveland, Colorado
Medical College of Wisconsin Milwaukee, Wisconsin
Medical University of South Carolina Charleston, South Carolina
Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital The Bronx, New York
Morristown Medical Center Morristown, New Jersey
Mount Sinai Medical Center Miami Beach, Florida
NCH Healthcare System Naples, Florida
Northwestern University Chicago, Illinois
Ochsner Medical Center New Orleans, Louisiana
Oklahoma Cardiovascular Research Group Oklahoma City, Oklahoma
Oklahoma Heart Institute at Hillcrest Medical Center Tulsa, Oklahoma
Oregon Health & Science University Portland, Oregon
Penn State Hershey Hershey, Pennsylvania
Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania Philadelphia, Pennsylvania
Piedmont Healthcare, Inc. Atlanta, Georgia
Pinnacle Health Cardiovascular Institute/UPMC Pinnacle Wormleysburg, Pennsylvania
Providence St. Patrick Hospital Missoula, Montana
Rochester General Hospital Rochester, New York
Rutgers Robert Wood Johnson Medical School New Brunswick, New Jersey
SCPMG - Kaiser San Diego La Jolla, California
Saint Luke's Hospital of Kansas City Kansas City, Missouri
Sanford Medical Center Fargo Fargo, North Dakota
Sarasota Memorial Health Care System Sarasota, Florida
St. Francis Hospital Roslyn, New York
St. George Regional Hospital St. George, Utah
St. Joseph Hospital Bethpage, New York
St. Mary's of Ascension Research Saginaw, Michigan
St. Michael's Hospital Toronto, Ontario
St. Paul's Hospital Iloilo City,
Stanford University Palo Alto, California
State University Of New York at Buffalo Buffalo, New York
Sunnybrook Health Sciences Centre Toronto, Ontario
Swedish Medical Center Englewood, Colorado
Tallahassee Research Institute Tallahassee, Florida
The Cardiac and Vascular Institute Research Foundation Gainesville, Florida
The Christ Hospital Cincinnati, Ohio
The Ohio State University Columbus, Ohio
The University of Texas Health Science Center at Houston Houston, Texas
TriHealth-Bethesda North Hospital Cincinnati, Ohio
Tucson Medical Center HealthCare Tucson, Arizona
UCLA Medical Center Los Angeles, California
UTHealth/Memorial Hermann Hospital Houston, Texas
University of California, Irvine Orange, California
University of California, San Francisco San Francisco, California
University of Iowa Hospitals & Clinics Iowa City, Iowa
University of Michigan Ann Arbor, Michigan
University of North Carolina Chapel Hill, North Carolina
University of Ottawa Heart Institute Ottawa, Ontario
University of Virginia Health System Charlottesville, Virginia
Vanderbilt University Medical Center Nashville, Tennessee
Virginia Commonwealth University Richmond, Virginia
Virginia Mason Medical Center Seattle, Washington
Washington University School of Medicine St Louis, Missouri
Weill Cornell Medicine New York, New York
William Beaumont Hospital - Royal Oak Royal Oak, Michigan

Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment (CRT-DRIVE)

Claudia M Amatruda, PhD - amatruda@xspline.com

NCT05327062
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Eligible subjects shall meet all following criteria:
• Appropriately signed and dated informed consent.
• Age ≥18 years at time of consent.
• CRT indication according to the 2021 ESC guidelines on cardiac pacing and CRT (class I and IIA indication in patients with LBBB QRS morphology) or to 2017 AHA/ACC/HFSA guidelines (COR I).
• Sinus rhythm
• QRS duration ≥130 ms
• Left bundle branch block
• Left ventricular ejection fraction ≤35%
• Symptomatic heart failure NYHA class ≥ II
• Documented stable medical treatment for at least 6 months
• No cardiovascular intervention during the last 6 month Exclusion Criteria are:
• History of persistent or permanent atrial fibrillation
• Previous pacemaker or ICD implantation
• Indication to pacing due to bradycardia
• Patients considered for His bundle pacing or cardiac conduction pacing
• Patients with unstable angina
• Subject experienced a recent myocardial infarction, within 40 days prior to enrollment
• Subject underwent coronary artery bypass graft or valve surgery, within 90 days prior to enrollment
• Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
• Subject is implanted with a left ventricular assist device
• Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
• Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)
• Subject has congenital heart disease
• Subject has a mechanical right-sided heart valve
• Subject has a life expectancy of less than one year in the opinion of the investigator
• Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
• Subject is enrolled in one or more concurrent studies that would confound the results of this study
• Patients who have contraindications to CT scanning.
• Patients with chronic kidney diseases and estimated glomerular filtration rate (eGMR) calculated based on CKD-EPI 2009 < 40 ml/min/1.73m2
Device: CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block
Non-invasive activation mapping, Coronary Sinus
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Amsterdam University Medical Center Amsterdam, Reinoud Knops - (r.e.knops@amsterdamumc.nl)
Duke University Hospital Durham, North Carolina Daniel Friedman - (daniel.friedman@duke.edu)
General Hospital of Bolzano Bolzano, Rainer Oberhollenzer - (rainer.oberhollenzer@sabes.it)
Istituto Cardiocentro Ticino Lugano, Tessin Angelo Auricchio - (angelo.auricchio@eoc.ch)
King's College Hospital London, Aldo Rinaldi - (aldo.rinaldi@kcl.ac.uk)
Maastricht University Medical Center Maastricht, Limburg Kevin Vernooy - (kevin.vernooy@mumc.nl)
Massachusetts General Hospital Boston, Massachusetts Jag Singh - (JSINGH@mgh.harvard.edu)
Ordensklinikum Linz Elisabethinen Hospital Linz, Helmut Puererfellner - (helmut.puererfellner@ordensklinikum.at)
Policlinico Casilino Rome, Leonardo Calò - (leonardo.calo@icloud.com)
Queen Elizabeth Hospital Kota Kinabalu, Francisco Leyva - (cardiologists@hotmail.com)
Rush University Medical Center Chicago, Illinois Parikshit S Sharma - (parikshit_S_Sharma@rush.edu)
Semmelweis University Budapest, Bela Merkely - (merkely.bela@gmail.com)
The University of Chicago Medicine Chicago, Illinois Gaurav Upadhyay - (gupadhyay@medicine.bsd.uchicago.edu)
UKSH Universitätsklinikum Schleswig-Holstein Kiel, Thomas Demming - (thomas.demming@uksh.de)
Univeristat de Barcelona Barcelona, Lluis Mont - (lmont@clinic.cat)
Virginia Commonwealth University School of Medicine Richmond, Virginia Kenneth Ellenbogen - (kenneth.ellenbogen@vcuhealth.org)

Quality of Pediatric Resuscitation in a Multicenter Collaborative (pediRES-Q)

Vinay Nadkarni, MD, MS - nadkarni@chop.edu

NCT02708134
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Inclusion Criteria:
* Patient received chest compressions for at least 1 minute * Patient between gestational age ≥37 weeks and 18 years of age
Exclusion Criteria:
* Patient on veno-arterial extracorporeal membrane oxygenation (ECMO) therapy at beginning of CPR event
Cardiac Arrest, Cardiopulmonary Arrest
Chest compressions, Cardiopulmonary Resuscitation, Pediatric
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Study Locations

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Aichi Children's Health and Medical Center Ōbu,
Akron Children's Akron, Ohio
Albany Medical Center Albany, New York
Alberta Children's Calgary,
All Children's Hospital St. Petersburg, Florida
BC Children's Vancouver, British Columbia
Boston Children's Boston, Massachusetts
Cedars-Sinai Medical Center Los Angeles, California
Children's Colorado Aurora, Colorado
Children's Healthcare of Atlanta (CHOA) Atlanta, Georgia
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Vinay Nadkarni, MD, MS - (nadkarni@chop.edu)
Children's Hospital of Richmond at VCU Richmond, Virginia
Chldren's Hospital of Orange County Orange, California
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio
Cohen Children's Medical Center Queens, New York
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire
Dell Children's Medical Center Austin, Texas
Erasmus MC - Sophia Children's Rotterdam,
Great Ormond Street Hospital London,
Gregorio Marañón General University Hospital Madrid,
IRCCS Ospedale Pediatrico Bambino Gesu Rome,
Instituto Roosevelt Bogotá,
KK Women's & Children's Hospital Singapore,
Kaiser Permanente Fresno, California
Kentucky Children's Hospital Lexington, Kentucky
King Chulalongkorn University Bangkok,
Kobe Children's Hospital (Hyogo Prefectural) Kobe,
Lurie Children's (Children's Hospital of Chicago) Chicago, Illinois
Massachusetts General Hospital Boston, Massachusetts
Medical City Children's Hospital Dallas, Texas
Medical College of Wisconsin Milwaukee, Wisconsin
Medical University of South Carolina Charleston, South Carolina
Morgan Stanley Children's Hospital New York, New York
Mount Sinai Kravis Children's Hospital New York, New York
National Taiwan University Hospital Taipei,
National University Hospital Singapore,
Nationwide Children's Hospital Columbus, Ohio
Nebraska Medical Center Omaha, Nebraska
Nemours Children's Hospital Orlando, Florida
Perth Children's Hospital Perth, Western Australia
Queensland Children's Hospital South Brisbane, Queensland
Rady Children's Hospital San Diego, California
Riley Hospital for Children Indianapolis, Indiana
Sabara Hospital Infantil São Paulo,
Seattle Children's Hospital Seattle, Washington
Seoul National University Bundang Hospital Seongnam,
St. Louis Children's Hospital St Louis, Missouri
Stanford University Palo Alto, California
Starship Children's Hospital Grafton, Auckland
Stollery Children's Hospital Edmonton,
Stony Brook University Hospital Stony Brook, New York
The Children's Hospital at Westmead Westmead, New South Wales
The Children's Hospital of San Antonio San Antonio, Texas
The Johns Hopkins Hospital Baltimore, Maryland
Tokyo Metropolitan Children's Medical Center Tokyo,
University of Chicago, Comer Children's Hospital Chicago, Illinois
University of Iowa Stead Family Children's Hospital Iowa City, Iowa
University of North Carolina Chapel Hill, North Carolina
University of Texas Southwestern Dallas, Texas
Upstate Golisano Children's Hospital Syracuse, New York
Valley Children's Hospital Madera, California

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Gwaltney, Lindsey - lbgwaltney@vcu.edu

Boomer, Laura, A
NCT05235165
HM20024392
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Inclusion Criteria:
* Patients must be \< 50 years at the time of enrollment. * Patients must have =\< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \>= 3 mm and all of which must be =\< 3 cm size. * Note: Patient must have eligibility confirmed by rapid central imaging review. * Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon. * Patients must have a histological diagnosis of osteosarcoma. * Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease. * Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery. * Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation. * Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
Exclusion Criteria:
* Patients with unresectable primary tumor. * Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi). * Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion. * Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team. * Patients with evidence of extrapulmonary metastatic disease. * Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment. * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, OTHER: Questionnaire Administration, PROCEDURE: Thoracoscopy, PROCEDURE: Thoracotomy
Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Osteosarcoma
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Study Locations

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Location Contacts
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)
Ann M Wierman MD LTD Las Vegas, Nevada
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Banner Children's at Desert Mesa, Arizona
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.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)
C S Mott Children's Hospital Ann Arbor, Michigan
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carilion Children's Roanoke, Virginia Site Public Contact - (wpmccarty@carilionclinic.org)
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
Cedars-Sinai Medical Center Los Angeles, California Site Public Contact - (Cancer.trial.info@cshs.org)
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 at Montefiore The Bronx, New York Site Public Contact - (aaraiza@montefiore.org)
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 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)
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)
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 - 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)
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
Eastern Maine Medical Center Bangor, Maine
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)
HIMA San Pablo Oncologic Hospital Caguas,
Hackensack University Medical Center Hackensack, New Jersey
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)
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 Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Anaheim Anaheim, 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-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
King Faisal Specialist Hospital and Research Centre Riyadh,
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Las Vegas Cancer Center-Henderson Henderson, Nevada
Las Vegas Cancer Center-Medical Center Las Vegas, Nevada
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)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Emanuel Children's Hospital Portland, Oregon
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)
Maimonides Medical Center Brooklyn, New York
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
Mayo Clinic in Rochester Rochester, Minnesota
Medical City Dallas Hospital Dallas, Texas
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
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)
Michigan State University East Lansing, Michigan
Miller Children's and Women's Hospital Long Beach Long Beach, California
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
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)
Morristown Medical Center Morristown, New Jersey
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
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)
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
Nicklaus Children's Hospital Miami, Florida
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington Site Public Contact - (Memorial-ClinicalTrials@yvmh.org)
Northern Nevada Radiation Oncology Reno, Nevada
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)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oncology Las Vegas - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oncology Las Vegas - Tenaya Las Vegas, Nevada Site Public Contact - (research@sncrf.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)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Overlake Medical Center Bellevue, Washington
PCR Oncology Arroyo Grande, California Site Public Contact - (research@sncrf.org)
Penn State Children's Hospital Hershey, Pennsylvania
Perth Children's Hospital Perth, Western Australia
Phoenix Childrens Hospital Phoenix, Arizona
Presbyterian Hospital Albuquerque, New Mexico Site Public Contact - (wburman@phs.org)
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 Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
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)
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)
Royal Children's Hospital Parkville, Victoria
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 Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Jude 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 Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)
Starship Children's Hospital Grafton, Auckland
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
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)
Tampa General Hospital Tampa, Florida Site Public Contact - (syapchanyk@tgh.org)
Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas
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
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health Muskegon Hospital Muskegon, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University Medical Center of Southern Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
University of Alberta Hospital Edmonton, Alberta Site Public Contact - (pedsoncologyresearch@ahs.ca)
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Michigan Health - West Wyoming, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
University of Michigan Rogel Cancer Center Ann Arbor, Michigan Site Public Contact - (CancerAnswerLine@med.umich.edu)
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of Missouri Children's Hospital Columbia, Missouri Site Public Contact - (snwq62@health.missouri.edu)
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Vermont and State Agricultural College Burlington, Vermont
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)
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 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)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Valley Medical Center Renton, Washington Site Public Contact - (research@valleymed.org)
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)
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
West Virginia University Healthcare Morgantown, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Westchester Medical Center Valhalla, New York Site Public Contact - (ctsucontact@westat.com)
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)

Marco Carini, Prof. - carini@unifi.it

NCT05363657
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Inclusion Criteria:

• Radiological diagnosis of renal tumor susceptible to active treatment or AS/WW.
• Age ?18 years
• Informed consent signed
Exclusion Criteria:

• Patient refuse to participate in clinical research.
• Urothelial renal carcinoma.
Procedure: Partial Nephrectomy (PN), Procedure: Radical Nephrectomy (RN), Procedure: Ablation therapy (AT), Diagnostic Test: Active Surveillance (AS)
Kidney Cancer
Kidney cancer, Partial Nephrectomy, Radical Nephrectomy, Ablation Techniques, Active Surveillance, Recurrence Free Survival, Watchful Waiting
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AOUI Verona Verona, Alessandro Antonelli - (alessandro.antonelli@me.com)
Amsterdam University Medical Centers Amsterdam, Axel Bex - (a.bex@nki.nl)
Azienda Ospedaliera Policlinico "G. Martino", Universit? di Messina. Messina, Vincenzo Ficarra - (vficarra@unime.it)
Bristol Urological Institute Bristol, Francis Keeley - (Francis.Keeley@nbt.nhs.uk)
Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital Firenze, Andrea Mari - (andrea.mari@unifi.it)
Division of Urology, University of Genoa,Policlinico San Martino Hospital Genova, Carlo Terrone - (carlo.terrone@med.uniupo.it)
European Health Center Otwock, Lukasz Nyk - (ukinyk@poczta.fm) Hubert Kamecki - (hubert@kamecki.pl)
Fundaci? Puigvert Barcelona, Joan Palou - (ipalou@fundacio-puigvert.es)
Guy's Hospital London, Ben Challacombe - (benchallacombe@doctors.org.uk)
Hospital Universitario Ram?n y Cajal, University of Alcal Madrid, Vital Hevia - (vital.hevia.uro@gmail.com)
Humanitas Hospital Rozzano, Nicolomaria Buffi - (nicolo.buffi@hunimed.eu)
Institute Oncology Veneto (IOV) Padova, Angelo Porreca - (angeloporreca@gmail.com)
Institute of Urology, University of Southern California. Los Angeles, California Giovanni E Cacciamani - (giovanni.cacciamani@med.usc.edu)
Istituto Nazionale dei Tumori Fondazione Senatore "G. Pascale" Napoli, Sisto Perdona' - (s.perdona@istitutotumori.na.it)
Jikei University School of Medicine Minato-ku, Tokyo, Shin Egawa - (s-egpro@jikei.ac.jp)
Loyola University Medical Center, Edward Hines VA Hospital Chicago, Illinois Gopal Gupta - (GOGUPTA@lumc.edu)
Medical University of Vienna, Vienna General Hospital Vienna, Shahkrokh F Shariat - (shahrokh.shariat@meduniwien.ac.at)
N.N. Blokhin National Medical Research Center of Oncology Moscow, Vsevolod Matveev - (vsevolodmatveev@mail.ru)
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Warsaw, Roman Sosnowski - (roman.sosnowski@gmail.com)
Ng Teng Fong General Hospital Singapore, Vineet Gaauhaar - (vineetgaauhaar@gmail.com)
Onze Lieve Vrouw Hospital Leuven, Geert De Naeyer - (geertdenaeyer@yahoo.com)
Policlinico Istituto Europeo di Oncologia (IEO) Milano, Ottavio De Cobelli - (Ottavio.DeCobelli@ieo.it)
Policlinico Riuniti, Universit? di Foggia. Foggia, Giuseppe Carrieri - (giuseppe.carrieri@unifg.it) Gian Maria Busetto - (gianmaria.busetto@unifg.it)
Policlinico S. Orsola Malpighi Bologna, Riccardo Schiavina - (rschiavina@yahoo.it)
San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital Milano, Umberto Capitanio - (umbertocapitanio@gmail.com)
Santa Casa da Miseric?rdia de Fortaleza Fortaleza, Francisco Hidelbrando A Mota Filho - (fha.motafilho@gmail.com)
Stanford University Palo Alto, California Benjamin I Chung - (bichung@stanford.edu)
Swedish Hospital Seattle, Washington James Porter - (porter@swedishurology.com)
Universit? degli Studi di Torino, Ospedale S. Luigi Gonzaga. Torino, Francesco Porpiglia - (porpiglia@libero.it)
Universit? degli studi di Torino, Ospedale Molinette Torino, Paolo Gontero - (paolo.gontero@unito.it)
University Hospitals Leuven Leuven, Maarten Albersen - (maarten.albersen@uzleuven.be)
University of Bruxelles Bruxelles, Simone Albisinni - (albisinni.simone@gmail.com)
University of California San Diego, Moores Cancer Center San Diego, California Ithaar Derweesh - (iderweesh@gmail.com)
University of Patras Patras, Evangelos Liatsikos - (liatsikos@yahoo.com)
University of Pennsylvania Philadelphia, Pennsylvania Philip Pierorazio - (Phillip.Pierorazio@pennmedicine.upenn.edu)
Urology, Andrology & Kidney Transplantation Unit, University of Bari Bari, Pasquale Ditonno - (pasquale.ditonno@uniba.it)
VCU Health System Richmond, Virginia Riccardo Autorino - (ricautor@gmail.com)

Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer

Iovance Biotherapeutics Study Team lungcelltherapy.com - Clinical.Inquiries@iovance.com

Poklepovic, Andrew, S
NCT04614103
HM20023194
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Inclusion Criteria:
* Patients who are over 70 years of age may be allowed to enroll after discussion with the Medical Monitor. * Have historically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC without EGFR, ALK, or ROS1 genomic alterations. * For patients who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate health authority approved targeted therapy is required. * Patients must have documented radiographic disease progression on or after the first-line therapy, including concurrent or sequential ICI and platinum-based chemotherapy ± bevacizumab. No more than 1 prior line is allowed if ICI and platinum-based chemotherapy were administered concurrently and no more than 2 prior lines are allowed for sequential administration of platinum-based chemotherapy and ICI as 2 separate lines. * LN-145 manufacture is allowed for patients who have residual resectable disease after completion of the platinum-based chemotherapy component of the front-line ICI and platinum-based chemotherapy combination and meet all eligibility criteria except documented disease progression. These patients must intend to receive TIL therapy after disease progression * Prior systemic therapy in the adjuvant or neoadjuvant setting, or as part of definitive chemoradiotherapy, will count as a line of therapy if the patient had disease progression during or within 12 months after the completion of such therapy. * At least 1 resectable lesion for TIL production and at least one remaining measurable lesion, as defined by RECIST v1.1 * Have adequate organ function * LVEF \> 45%, NYHA Class 1 * Have adequate pulmonary function * ECOG performance status of 0 or 1 * Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy
Exclusion Criteria:
* Patients who have EGFR, ALK or ROS1 driver mutations * Patients who have symptomatic, untreated brain metastases. * Patients who have had allogeneic organ transplant or prior cell therapy within the past 20 years * Patients who have any form of primary immunodeficiency * Patients who are on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent. * Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment * Patients who have had another primary malignancy within the previous 3 years * Participation in another interventional clinical study within 21 days
BIOLOGICAL: LN-145, BIOLOGICAL: LN-145
Metastatic Non Small Cell Lung Cancer
LN-145, Cell Therapy, Autologous Adoptive Cell Therapy, Cellular Immuno-therapy, Tumor Infiltrating Lymphocytes, TIL, IL-2, Non Small Cell Lung Cancer, NSCLC, Second line Lung Cancer, Bronchial Neoplasms, Carcinoma, Lung Disease, Metastatic Lung Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic NSCLC, Lung Carcinoma, PD-L1, Stage IV Lung Cancer, Stage IV Non-Small Cell Lung Cancer, Stage IV NSCLC, Systemic Therapy, 2nd line therapy, Second line therapy, CPI, Immune checkpoint inhibitor (ICI), NSCLC Recurrent, Recurrent Lung Cancer, Recurrent Lung Carcinoma
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Study Locations

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AdventHealth Cancer Institute Orlando, Florida
Advocate Aurora Health Park Ridge, Illinois
Allegheny General Hospital Pittsburgh, Pennsylvania
Atrium Health Wake Forest University Health Sciences Winston-Salem, North Carolina
Augusta University Augusta, Georgia
Avera Medical Group Cancer Institute Sioux Falls, South Dakota
Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro,
Azienda Ospedaliera Universitaria Careggi Florence,
Banner Health MD Anderson Gilbert, Arizona
Baptist Cancer Center Memphis, Tennessee
C.H. Regional Reina Sofia Córdoba,
CHRU de Poitiers La Miletrie Poitiers,
CHU Nantes Nantes,
CHU Nice Nice,
Centre Hospitalier Lyon Sud Pierre-Bénite,
Centre Hospitalier Universitaire Vaudois Lausanne Lausanne, Canton of Vaud
Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec
Charite- Universitätsklinikum Berlin Berlin,
Christiana Care Health System Newark, Delaware
City of Hope Duarte, California
Clinical Universitaria de Navarra Pamplona,
Consorcio Hospital General Universitario de Valencia Valencia,
Dana Farber Cancer Institute Boston, Massachusetts
Fondazione IRCCS Policlinico San Matteo di Pavia Pavia,
Fox Chase Cancer Center Philadelphia, Pennsylvania
Gachon Unversity Gil Medical Center Incheon,
Gustave Roussy Cancer Campus Villejuif,
Guy's Hospital London,
H Lee Moffitt Cancer Center and Research Institute Tampa, Florida
Henry Ford Health System West Bloomfield, Michigan
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis Amsterdam,
Hollywood Private Hospital Ramsay Nedlands, Western Australia
Hospital Clinic de Barcelona Barcelona,
Hospital Clinico Universitario de Valencia Valencia,
Hospital Regional Universitario de Malaga Málaga,
Hospital Universitario 12 de Octubre Madrid,
Hospital Universitario A Coruna A Coruña, LA Coruna
Hospital Universitario La Paz Madrid,
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal Madrid,
Hospital Universitario Ramon y Cajal Madrid,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario de Salamanca Salamanca,
Houston Methodist Houston, Texas
IRCCS Fondazione del Piemonte per l'Oncologia Piemonte,
Icahn School of Medicine at Mount Sinai New York, New York
Institut Paoli Calmettes Marseille,
Instituto Oncologico Rosell Barcelona,
Karmanos Cancer Institute Detroit, Michigan
MD Anderson Cooper Camden, New Jersey
Memorial Sloan Kettering Cancer Center New York, New York
National Cancer Centre Singapore Singapore,
New York University Langone Medical Center New York, New York
Novant Health - Charlotte Charlotte, North Carolina
Novant Health - Winston-Salem Winston-Salem, North Carolina
Ohio State University Comprehensive Cancer Center Columbus, Ohio
Oregon Health and Science University Portland, Oregon
Princess Margaret Cancer Centre Toronto, Ontario
Roswell Park Cancer Institute Buffalo, New York
Royal Marsden Hospital London,
Rush University Medical Center Chicago, Illinois
Samsung Medical Center Seoul,
Sanford Cancer Center Sioux Falls, South Dakota
Sanford Roger Maris Cancer Center Fargo, North Dakota
Sarah Cannon Research Institute Nashville, Tennessee
Seattle Cancer Care Alliance Seattle, Washington
Severance Hospital, Yonsei University Seoul,
St. Vincent's Hospital Fitzroy, Victoria
Sylvester Comprehensive Cancer Center Plantation, Florida
Texas Oncology-Baylor Charles A. Sammons Cancer Center The Woodlands, Texas
The Christie NHS Foundation Trust Manchester,
UC San Diego Moores Cancer Center La Jolla, California
Universitatsklinikum Bonn Bonn, North Rhine-Westphalia
Universitatsklinikum Mannheim Mannheim,
University College London London,
University Hospital of Zurich/ Universitätsspital Zürich Zurich,
University of Cincinnati Medical Center Cincinnati, Ohio
University of Florida Health Cancer Center Gainesville, Florida
University of Illinois Hospital & Health Sciences System Chicago, Illinois
University of Kentucky-Markey Cancer Center Lexington, Kentucky
University of Louisville Louisville, Kentucky
University of Maryland Towson, Maryland
University of Minnesota Minneapolis, Minnesota
University of Nebraska Medical Center Omaha, Nebraska
University of North Carolina Chapel Hill, North Carolina
University of Oklahoma Oklahoma City, Oklahoma
University of Rochester Medical Center Rochester, New York
University of Southern California Los Angeles, California
University of Tennessee Medical Center Knoxville, Tennessee
Universitätsklinikum Carl Gustav Carus, MK I Dresden,
VCU Medical Center (Virginia Commonwealth University) Richmond, Virginia
Westmead Hospital Westmead, New South Wales

Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant

Sherry Boyett, RN - sherry.boyett@vcuhealth.org

NCT05424003
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Inclusion Criteria:
* Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.) * Liver transplant surgery within 8-24 weeks prior to randomization * Fasting glucose \> 125 mg/dL or presence of diabetes (HbA1c≥6.5% or use of diabetes medications) or pre-diabetes (HbA1c \>5.7%) * Ability to provide informed consent * Discharged from the hospital following LT surgery * Tolerating diet * Normal graft function\* (determined by treating hepatologist/surgeon based on clinical status and hepatic panel) * Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols \*\* (i.e. calcineurin inhibitors + mycophenolate) * Eligible female patients will be (1) non-pregnant, evidenced by a negative urine pregnancy test, (2) non-lactating, (3)surgically sterile or post-menopausal, or they will agree to continue to use an accepted method of birth control during the study
Exclusion Criteria:
* BMI≤ 27kg/m2 * GFR (Glomerular Filtration Rate) ≤ 25 ml/min/1.73m2 * Type 1 autoimmune diabetes (by anti-GAD (glutamic acid decarboxylase) or history of ketoacidosis) * History of gastroparesis * Familial or personal history of medullary thyroid cancer or MEN (Multiple Endocrine Neoplasia) 2 * History of pancreatitis * History of active malignancy post- LT with the exception of non-melanoma skin cancers * History of uncontrolled or unstable diabetic retinopathy or maculopathy * Acute cellular rejection * Hepatic artery thrombosis * Medical non-compliance * Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening * History of hypersensitivity to semaglutide or its excipients * Women who are nursing, pregnant, or planning to become pregnant during the study, or are not using adequate contraceptive measures
DRUG: Semaglutide Pen Injector, DRUG: Placebo
NAFLD
Liver Transplant
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Virginia Commonwealth University Richmond, Virginia

Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia (SCIMS Main)

Ashraf Gorgey, MPT, PhD, FACSM, FACRM - Ashraf.Gorgey@va.gov

NCT05423600
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Inclusion Criteria:

• A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.
• Participants must have a companion that will be able to help him/her throughout the study.
• Greater than 1-year post SCI, neurologic level of C8 or above.
• American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.
• Visible muscle contraction response to NMES wrist extensors, bilaterally.
• Agreement to use telehealth services for delivery of research exercise training by study staff. Possesses appropriate technology to engage in telehealth including a personal web camera, computer, microphone, speakers, and high-speed broadband internet connection, valid email address (needed to obtain VA issued video conferencing software), and telephone number used to obtain login credentials for the In-Home Video Software - Cisco Jabber Video for Telepresence Software.
• Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation.
Exclusion Criteria:

• Unhealed fracture in upper or lower extremities.
• Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or valid evaluation of outcome measures.
• High resting blood pressure greater than 140/80 mmHg.
• Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
• Pregnancy (female participants). A home pregnancy test will be conducted to role out any pregnancy before the study at the McGuire VAMC. The test will be repeated every month during the course of the study.
• Implanted pacemakers and/or implanted defibrillator devices.
• Other exclusion criteria may include the presence of implanted electrical device, cancer, thrombosis, pacemaker, defibrillator, or seizures. Patients who are currently on or receive anti-platelet or anticoagulant medications will be excluded from the trial.
• Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
• Other exclusion criteria at the discretion of the medical team may include:
• Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI
• Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke.
• Unresolved deep vein thrombosis.
• Psychiatric or cognitive impairments that preclude adherence to the intervention.
• Known cardiac pathology that precludes safe participation.
• Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin.
• Presence of pressure sores stage three or greater.
• Presence of a symptomatic urinary tract infection.
• Severe spasticity as assessed by the Modified Ashworth Scale.
• Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.
PROCEDURE: BES + TS, PROCEDURE: Experimental: BES+sham TS
Tetraplegia/Tetraparesis
Spinal Cord Injury
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Richmond VA Medical Center Richmond, Virginia
Sheltering Arms Physical Rehabilitation Centers Richmond, Virginia
Virginia Commonwealth University Richmond, Virginia

Children's Bipolar Network Treatment Trial I (CBN)

David J Miklowitz, PhD - dmiklowitz@mednet.ucla.edu

NCT05427123
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Inclusion Criteria:
* Youth 9-19 years old * Youth diagnosed with Bipolar disorder (I, II, Other Specified) or Cyclothymic Disorder by the study team during the diagnostic interview screening * Youth is able to read and communicate in English to the degree necessary to be able to assent and participate (with help) in their treatment and assessments appropriate for ages 9 and up * Youth has a caregiver able to participate in ongoing basis in assessment and treatment * The participating caregiver can reliably read and communicate in English for purposes of study consenting, assessment, and treatment, unless preferred language translation services are regularly available.
Exclusion Criteria:
* Youth has DSM-5 diagnosis of autism spectrum disorder * Youth has DSM-5 diagnosis of substance or alcohol abuse with impairment within 3 mos. * Youth has a medical or psychiatric disorder that is life-threatening or requires immediate hospitalization or emergency medical or therapeutic treatment * Evidence of recent sexual or physical abuse of the youth by legally responsible caregivers * Evidence of recent intimate partner violence between caregivers responsible for the youth's care
OTHER: Medication or psychosocial treatment
Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder, Mood Instability, Child Mental Disorder, Adolescent - Emotional Problem
medication, psychosocial, treatment, longitudinal, naturalistic, assessment
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University of California, Los Angeles, Max Gray Child and Adolescent Mood Disorders Program (CHAMP) Los Angeles, California David J Miklowitz, PhD - (dmiklowitz@mednet.ucla.edu) Megan C Ichinose, PhD - (michinose@mednet.ucla.edu)
University of Colorado Anschutz Medical Campus, Helen and Arthur E. Johnson Depression Center Aurora, Colorado
University of Pittsburgh Child and Adolescent Bipolar Spectrum Services Clinic (CABS) Pittsburgh, Pennsylvania
Virginia Commonwealth University Medical Center Richmond, Virginia

GiST (GiST)

Vences, Karina - venceskm@vcu.edu

Goldman, Myla
NOT REQUIRED
HM20022775
Diseases of Nervous System and Sense Organs (320-389)
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Virginia Commonwealth University Richmond, Virginia Vences, Karina - (venceskm@vcu.edu)

Uptake of NCI Research Tested Intervention Program to Increase CRC Screening in Rural Setting

Preston, Michael - prestonm2@vcu.edu

Preston, Michael
16928
HM20019703
Rectum, Colon
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Virginia Commonwealth University Richmond, Virginia Preston, Michael - (prestonm2@vcu.edu)

Community Outreach and Engagement Key Informant Interviews

Cummings, Yvonne - yvonne.cummings@vcuhealth.org

Sheppard, Vanessa, B.
15900
HM20018062
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Virginia Commonwealth University Richmond, Virginia Cummings, Yvonne - (yvonne.cummings@vcuhealth.org)

A Cognitive Task Analysis of Pediatric Hematology/Oncology Faculty

DiazGranados, Deborah - diazgranados@vcu.edu

Helou, Marieka, Ann
15801
HM20017417
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Virginia Commonwealth University Richmond, Virginia DiazGranados, Deborah - (diazgranados@vcu.edu)

CASTOR-2: Identifying Subclinical Cardiotoxicity Following RT for Locally Advanced Lung Cancer (CASTOR-2)

Kontos, Emily - kontosej@vcu.edu

Thomas, Georgia
15564
HM20017432
Lung
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Virginia Commonwealth University Richmond, Virginia Kontos, Emily - (kontosej@vcu.edu)

Killer Immunoglobulin-Like Receptor Interactions to Optimize Natural Killer Cell Function in SCT

Roberts, Catherine, H. - croberts2@vcu.edu

Toor, Amir, A
15122
HM20016672
Other Hematopoietic
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Virginia Commonwealth University Richmond, Virginia Roberts, Catherine, H. - (croberts2@vcu.edu)

Biomarkers of Malignant and Non-Malignant Pleural Effusion

Narron, Kyle, A - Kyle.Narron@vcuhealth.org

Shojaee, Samira
15081
HM20012669
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Virginia Commonwealth University Richmond, Virginia Narron, Kyle, A - (Kyle.Narron@vcuhealth.org)

Unpacking Multilevel Drivers of Cardiotoxicity Disparities in Breast Cancer Survivors

Sutton, Arnethea - abrahamal@vcu.edu

Sheppard, Vanessa, B.
16953
HM20019941
Breast
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Virginia Commonwealth University Richmond, Virginia Sutton, Arnethea - (abrahamal@vcu.edu)

Cognitive Support Technology for Postsecondary Students with Traumatic Brain Injuries

Getzel, Elizabeth, E - lgetzel@vcu.edu

Getzel, Elizabeth, E
17135
HM20019040
External Causes of Injury and Poisoning (800-999)
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Virginia Commonwealth University Richmond, Virginia Getzel, Elizabeth, E - (lgetzel@vcu.edu)

Prognostic Gene Expression Profiling and Adjuv Therapy in Stage IIB-C & IIIA-B Cutaneous Melanoma

Gnanasigamani Manogaram, Merlin Margaret - gnanasigamam@vcu.edu

Poklepovic, Andrew, S
17390
HM20021149
Melanoma, skin
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Virginia Commonwealth University Richmond, Virginia Gnanasigamani Manogaram, Merlin Margaret - (gnanasigamam@vcu.edu)

Feasibility, Acceptability, and Preliminary Effectiveness of the ICAN QUIT Tobacco Program at VCUH

Hunley, Rachel - rachel.hunley@vcuhealth.org

Hayes, Rashelle
17440
HM20020118
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Virginia Commonwealth University Richmond, Virginia Hunley, Rachel - (rachel.hunley@vcuhealth.org)

Assessing Electronic Cigarette Nicotine Flux (Project 2 Flux Study)

ctrrecruit@vcu.edu

Breland, Alison
19170
HM20018580
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Virginia Commonwealth University Richmond, Virginia

Longitudinal Survey and Behavior Assessment of Experienced E-cigarette Users (P4 @ VCU)

ctrrecruit@vcu.edu

Breland, Alison
19168
HM20018209
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Virginia Commonwealth University Richmond, Virginia

Salad Bars in the National School Lunch Program

ctrrecruit@vcu.edu

Bean, Melanie, K.
19167
HM20012226
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Virginia Commonwealth University Richmond, Virginia

Predicting Effects of Tobacco Product Flavor Regs Among Black/African American Menthol Smokers

ctrrecruit@vcu.edu

Cobb, Caroline
19166
HM20022619
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Virginia Commonwealth University Richmond, Virginia

Effects of E-Cigarette Nicotine Delivery on Abuse Liability in Smokers

ctrrecruit@vcu.edu

Cobb, Caroline
19165
HM20018290
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Virginia Commonwealth University Richmond, Virginia

Massey Adult Community Cigar Study

ctrrecruit@vcu.edu

Cobb, Caroline
19162
HM20013308
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Virginia Commonwealth University Richmond, Virginia

Noninvasive Assessment of Esophageal Varices in Patients with Unresectable Hepatocellular Carcinoma

ctrrecruit@vcu.edu

Wedd, Joel
19108
HM20023235
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Virginia Commonwealth University Richmond, Virginia