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NCT07068074RecruitingPhase 3

Comparing the Effectiveness of Less Invasive Procedures With the Current Standard of Care for the Treatment of Older Adults With Early-Stage Melanoma

A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

This phase III trial compares the effect of wide local excision (WLE) alone to usual care with WLE plus sentinel lymph node (SLN) biopsy for the treatment of older adults with early-stage melanoma. A WLE is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue. This is sometimes followed by a SLN biopsy, in which lymph nodes that tumor cells could spread to are removed as well. Using WLE alone may be just as effective as usual care in treating older adults with early-stage melanoma.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
428 (estimated)
First submitted
17 Jun 2025
Start date
17 Apr 2026
Primary completion date
1 Jan 2031
Lead sponsor
ECOG-ACRIN Cancer Research Group
Diseases
Melanoma
NCT number
NCT07068074

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 428
  • From 17 Apr 2026 to the primary completion date, 1 Jan 2031
  • 181 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Patient must be ≥ 75 years of age.
  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • 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 newly diagnosed primary cutaneous melanoma with wide local excision (WLE) and sentinel lymph node (SLN) biopsy indicated per the treating physician, pending definitive surgical management.
    • NOTE: For WLE and SLN to be indicated, the patient must have either:
    • Pathologic features that include ≧ Breslow 0.8 mm OR Breslow \< 0.8 mm determined at initial biopsy, with a positive margin, ulceration, lymphovascular invasion, perineural invasion or \> 1 mitosis/mm\^2.
    • OR
  • Risk of SLN metastasis of at least 5%, as calculated using the Melanoma Institute of Australia (MIA) Sentinel Node Metastasis Prediction Tool.
    • Patient must be eligible for WLE and SLN biopsy. Patients for whom SLN biopsy would be contraindicated, difficult to perform (i.e., after prior surgery in the draining basin) or impossible (i.e., after prior lymphadenectomy for another cause) are not eligible.
    • Patient must be eligible for surgery and not have uncontrolled medical condition that in the opinion of the medical or surgical oncologist precludes surgical management.
    • Patient must not have an active infection that precludes enrollment to this study in opinion of treating investigator.
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.
    • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
    • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better.
    • Patient must be English speaking to be eligible for this study in order to complete the patient-reported outcomes (PROs).
    • NOTE: Sites cannot translate the associated quality of life (QOL) forms.

Age in the registry: 75 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (181)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesRecruiting
Lovelace Women's Hospital
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AlbuquerqueUnited StatesRecruiting
Community Hospital of Anaconda
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AnacondaUnited StatesRecruiting
Mission Hope Medical Oncology - Arroyo Grande
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Arroyo GrandeUnited StatesRecruiting
Emory University Hospital/Winship Cancer Institute
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AtlantaUnited StatesRecruiting
Emory Saint Joseph's Hospital
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AtlantaUnited StatesRecruiting
UCHealth University of Colorado Hospital
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AuroraUnited StatesRecruiting
UH Seidman Cancer Center at UH Avon Health Center
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AvonUnited StatesRecruiting
CommonSpirit Saint Joseph Hospital - Bardstown
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BardstownUnited StatesRecruiting
Our Lady of the Lake Physician Group
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Baton RougeUnited StatesRecruiting
LSU Health Baton Rouge-North Clinic
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Baton RougeUnited StatesRecruiting
Bronson Battle Creek
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Battle CreekUnited StatesRecruiting
UHHS-Chagrin Highlands Medical Center
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BeachwoodUnited StatesRecruiting
Sanford Joe Lueken Cancer Center
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BemidjiUnited StatesRecruiting
Central Vermont Medical Center/National Life Cancer Treatment
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Berlin CornersUnited StatesRecruiting
Billings Clinic Cancer Center
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BillingsUnited StatesRecruiting
University of Alabama at Birmingham Cancer Center
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BirminghamUnited StatesRecruiting
Sanford Bismarck Medical Center
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BismarckUnited StatesRecruiting
Bozeman Health Deaconess Hospital
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BozemanUnited StatesRecruiting
United Hospital Center
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BridgeportUnited StatesRecruiting
Roswell Park Cancer Institute
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BuffaloUnited StatesRecruiting
University of Vermont and State Agricultural College
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BurlingtonUnited StatesRecruiting
University of Vermont Medical Center
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BurlingtonUnited StatesRecruiting
Loyola Center for Health at Burr Ridge
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Burr RidgeUnited StatesRecruiting
Mercy Cancer Center - Carmichael
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CarmichaelUnited StatesRecruiting
Mercy San Juan Medical Center
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CarmichaelUnited StatesRecruiting
Duke Cancer Center Cary
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CaryUnited StatesRecruiting
Christiana Care Health System-Concord Health Center
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Chadds FordUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
University of Virginia Cancer Center
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CharlottesvilleUnited StatesRecruiting
Memorial Hospital of Laramie County
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CheyenneUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
Swedish Covenant Hospital
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ChicagoUnited StatesRecruiting
TriHealth Cancer Institute-Anderson
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CincinnatiUnited StatesRecruiting
TriHealth Cancer Institute-Westside
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CincinnatiUnited StatesRecruiting
Good Samaritan Hospital - Cincinnati
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CincinnatiUnited StatesRecruiting
Bethesda North Hospital
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CincinnatiUnited StatesRecruiting
Case Western Reserve University
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ClevelandUnited StatesRecruiting
Billings Clinic-Cody
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CodyUnited StatesRecruiting
Kootenai Health - Coeur d'Alene
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Coeur d'AleneUnited StatesRecruiting
Rocky Mountain Cancer Centers-Penrose
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Colorado SpringsUnited StatesRecruiting
Penrose-Saint Francis Healthcare
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Colorado SpringsUnited StatesRecruiting
Saint Francis Cancer Center
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Colorado SpringsUnited StatesRecruiting
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesRecruiting
Commonwealth Cancer Center-Corbin
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CorbinUnited StatesRecruiting
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
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DaphneUnited StatesRecruiting
Mercy Medical Center
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DurangoUnited StatesRecruiting
CommonSpirit Cancer Center Mercy
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DurangoUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesRecruiting
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
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East NorritonUnited StatesRecruiting
Mercy Cancer Center - Elk Grove
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Elk GroveUnited StatesRecruiting
Christiana Care - Union Hospital
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ElktonUnited StatesRecruiting
UPMC Hillman Cancer Center Erie
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ErieUnited StatesRecruiting
NorthShore University HealthSystem-Evanston Hospital
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EvanstonUnited StatesRecruiting
Fairbanks Memorial Hospital
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FairbanksUnited StatesRecruiting
Thomas Hospital
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FairhopeUnited StatesRecruiting
Southpointe-Sanford Medical Center Fargo
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FargoUnited StatesRecruiting
Sanford Roger Maris Cancer Center
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FargoUnited StatesRecruiting
Sanford Broadway Medical Center
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FargoUnited StatesRecruiting
Sanford South University Medical Center
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FargoUnited StatesRecruiting
Sanford Medical Center Fargo
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FargoUnited StatesRecruiting
Glens Falls Hospital
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Glens FallsUnited StatesRecruiting
NorthShore University HealthSystem-Glenbrook Hospital
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GlenviewUnited StatesRecruiting
CHI Health Saint Francis
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Grand IslandUnited StatesRecruiting
Trinity Health Grand Rapids Hospital
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Grand RapidsUnited StatesSuspended
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand RapidsUnited StatesRecruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grand RapidsUnited StatesRecruiting
Benefis Sletten Cancer Institute
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Great FallsUnited StatesRecruiting
Great Falls Clinic
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Great FallsUnited StatesRecruiting
Hackensack University Medical Center
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HackensackUnited StatesRecruiting
Hackettstown Medical Center
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HackettstownUnited StatesRecruiting
Hi-Line Sletten Cancer Center
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HavreUnited StatesRecruiting
Benefis Helena Specialty Center
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HelenaUnited StatesRecruiting
NorthShore University HealthSystem-Highland Park Hospital
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Highland ParkUnited StatesRecruiting
Loyola Medicine Homer Glen
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Homer GlenUnited StatesRecruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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IrvineUnited StatesRecruiting
Beacon Kalamazoo
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KalamazooUnited StatesSuspended
West Michigan Cancer Center
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KalamazooUnited StatesRecruiting
Bronson Methodist Hospital
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KalamazooUnited StatesRecruiting
Beacon Kalamazoo Cancer Center
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KalamazooUnited StatesSuspended
Logan Health Medical Center
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KalispellUnited StatesRecruiting
University of Kansas Cancer Center - Briarcliff
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center - North
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Kansas CityUnited StatesRecruiting
CHI Health Good Samaritan
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KearneyUnited StatesRecruiting
UC San Diego Moores Cancer Center
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La JollaUnited StatesRecruiting
Northwestern Medicine Lake Forest Hospital
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Lake ForestUnited StatesRecruiting
Lakeland Regional Health Hollis Cancer Center
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LakelandUnited StatesRecruiting
Orlando Health Cancer Institute - Lake Mary
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Lake MaryUnited StatesRecruiting
CommonSpirit Saint Anthony Hospital Cancer Center
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LakewoodUnited StatesRecruiting
University of Kansas Cancer Center - Lee's Summit
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Lee's SummitUnited StatesRecruiting
Beebe Medical Center
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LewesUnited StatesRecruiting
CommonSpirit Saint Joseph Hospital - Lexington
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LexingtonUnited StatesRecruiting
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesRecruiting
CommonSpirit Saint Joseph Medical Center - East Lexington
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LexingtonUnited StatesRecruiting
Saint Joseph Radiation Oncology Resource Center
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LexingtonUnited StatesRecruiting
Veterans Affairs Loma Linda Healthcare System
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Loma LindaUnited StatesRecruiting
CommonSpirit Saint Joseph Hospital London
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LondonUnited StatesRecruiting
Monmouth Medical Center
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Long BranchUnited StatesRecruiting
Longmont United Hospital
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LongmontUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesRecruiting
Los Angeles General Medical Center
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Los AngelesUnited StatesRecruiting
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesRecruiting
WVUH-Berkely Medical Center
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MartinsburgUnited StatesRecruiting
Loyola University Medical Center
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MaywoodUnited StatesRecruiting
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
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Melrose ParkUnited StatesRecruiting
Froedtert Menomonee Falls Hospital
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Menomonee FallsUnited StatesRecruiting
Mercy Cancer Center
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MercedUnited StatesRecruiting
Beebe South Coastal Health Campus
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MillvilleUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
NYU Langone Hospital - Long Island
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MineolaUnited StatesRecruiting
Community Medical Center
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MissoulaUnited StatesRecruiting
Mobile Infirmary Medical Center
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MobileUnited StatesRecruiting
West Virginia University Healthcare
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MorgantownUnited StatesRecruiting
Morristown Medical Center
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MorristownUnited StatesRecruiting
CommonSpirit Saint Joseph Hospital Mount Sterling
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Mount SterlingUnited StatesRecruiting
Trinity Health Muskegon Hospital
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MuskegonUnited StatesSuspended
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesRecruiting
Christiana Care Health System-Christiana Hospital
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NewarkUnited StatesRecruiting
Medical Oncology Hematology Consultants PA
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NewarkUnited StatesRecruiting
Helen F Graham Cancer Center
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NewarkUnited StatesRecruiting
Froedtert and MCW Moorland Reserve Health Center
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New BerlinUnited StatesRecruiting
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesRecruiting
Newton Medical Center
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NewtonUnited StatesRecruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
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New YorkUnited StatesRecruiting
Corewell Health Lakeland Hospitals - Niles Hospital
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NilesUnited StatesRecruiting
Cancer and Hematology Centers of Western Michigan - Norton Shores
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Norton ShoresUnited StatesSuspended
Drexel Town Square Health Center
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Oak CreekUnited StatesRecruiting
Health Central
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OcoeeUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
Alegent Health Lakeside Hospital
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OmahaUnited StatesRecruiting
Alegent Health Bergan Mercy Medical Center
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OmahaUnited StatesRecruiting
Alegent Health Immanuel Medical Center
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OmahaUnited StatesRecruiting
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesRecruiting
Orlando Health Cancer Institute
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OrlandoUnited StatesRecruiting
Northwestern Medicine Orland Park
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Orland ParkUnited StatesRecruiting
University of Kansas Hospital-Indian Creek Campus
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Overland ParkUnited StatesRecruiting
University of Kansas Cancer Center-Overland Park
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Overland ParkUnited StatesRecruiting
John Theurer Cancer Center at From Road
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ParamusUnited StatesRecruiting
Camden Clark Medical Center
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ParkersburgUnited StatesRecruiting
NYU Langone Hospital - Suffolk
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PatchogueUnited StatesRecruiting
Fox Chase Cancer Center
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PhiladelphiaUnited StatesRecruiting
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesRecruiting
Cancer Center at Saint Joseph's
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PhoenixUnited StatesRecruiting
UPMC Hillman Cancer Center
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PittsburghUnited StatesRecruiting
Chilton Medical Center
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PomptonUnited StatesRecruiting
Kootenai Clinic Cancer Services - Post Falls
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Post FallsUnited StatesRecruiting
Princeton Community Hospital
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PrincetonUnited StatesRecruiting
Saint Mary Corwin Medical Center
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PuebloUnited StatesRecruiting
Duke Cancer Center Raleigh
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RaleighUnited StatesRecruiting
Corewell Health Reed City Hospital
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Reed CityUnited StatesRecruiting
Beebe Health Campus
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Rehoboth BeachUnited StatesRecruiting
Renown Regional Medical Center
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RenoUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
VCU Massey Cancer Center at Stony Point
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RichmondUnited StatesRecruiting
Mercy Cancer Center - Rocklin
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RocklinUnited StatesRecruiting
Mercy Cancer Center - Sacramento
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SacramentoUnited StatesRecruiting
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint JosephUnited StatesRecruiting
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Saint JosephUnited StatesRecruiting
Kootenai Clinic Cancer Services - Sandpoint
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SandpointUnited StatesRecruiting
Pacific Central Coast Health Center-San Luis Obispo
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San Luis ObispoUnited StatesRecruiting
Mission Hope Medical Oncology - Santa Maria
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Santa MariaUnited StatesRecruiting
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
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SaralandUnited StatesRecruiting
Fred Hutchinson Cancer Center
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SeattleUnited StatesRecruiting
University of Washington Medical Center - Montlake
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SeattleUnited StatesRecruiting
Saint Joseph Medical Center Hematology and Oncology - Silverdale
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SilverdaleUnited StatesRecruiting
Saint Joseph's Medical Center
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StocktonUnited StatesRecruiting
Stony Brook University Medical Center
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Stony BrookUnited StatesRecruiting
Overlook Hospital
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SummitUnited StatesRecruiting
Montefiore Medical Center-Einstein Campus
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The BronxUnited StatesRecruiting
Sanford Thief River Falls Medical Center
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Thief River FallsUnited StatesRecruiting
Community Medical Center
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Toms RiverUnited StatesRecruiting
Munson Medical Center
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Traverse CityUnited StatesRecruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
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West BendUnited StatesRecruiting
Saint Anthony North Hospital
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WestminsterUnited StatesRecruiting
Marshfield Medical Center - Weston
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WestonUnited StatesRecruiting
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesRecruiting
Asplundh Cancer Pavilion
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Willow GroveUnited StatesRecruiting
Christiana Care Health System-Wilmington Hospital
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WilmingtonUnited StatesRecruiting
Woodland Memorial Hospital
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WoodlandUnited StatesRecruiting
University of Michigan Health - West
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WyomingUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.