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NCT03091660Active, not recruitingPhase 3

S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer

S1602, A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming With Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-muscle Invasive Bladder Cancer

Source: ClinicalTrials.gov · Last updated 23 Mar 2026

Brief summary (registry, in English)

This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1000 (actual)
First submitted
21 Mar 2017
Start date
24 Feb 2017
Primary completion date
31 Dec 2025
Lead sponsor
SWOG Cancer Research Network
NCT number
NCT03091660

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1000
  • From 24 Feb 2017 to the primary completion date, 31 Dec 2025
  • 174 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

  • Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder within 90 days of registration
  • Patients must have had all grossly visible papillary tumors removed within 30 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to registration
  • Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of metastatic disease (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] scan) within 90 days prior to registration; patients with T1 disease must have re-resection confirming =\< T1 disease within 90 days prior to registration
  • Patients must have high-grade bladder cancer as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification
  • Patients must not have pure squamous cell carcinoma or adenocarcinoma
  • Patients' disease must not have micropapillary components
  • Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to registration: CT urogram, intravenous pyelogram, magnetic resonance (MR) urogram, or retrograde pyelograms
  • Patients must not have nodal involvement or metastatic disease
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible
  • Patients must have a Zubrod performance status of 0-2
  • Patients must not have received prior intravesical BCG
  • Patients must not have known history of tuberculosis
  • Patients must be PPD negative within 90 days prior to registration; PPD negativity is defined as \< 10 mm diameter induration (palpable, raised hardened area) in the volar forearm at 48-72 hours following injection with standard tuberculin dose (5 units, 0.1 ml)
  • Patients must be \>= 18 years of age
  • Patients must not be taking oral glucocorticoids at the time of registration
  • Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study
  • Prestudy history and physical must be obtained within 90days prior to registration
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients must be offered the opportunity to participate in specimen banking for future studies to include translational medicine studies

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (174)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Queen's Cancer Center - Pearlridge
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‘AieaUnited StatesUnknown status
Pali Momi Medical Center
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‘AieaUnited StatesUnknown status
Hawaii Cancer Care - Savio
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‘AieaUnited StatesUnknown status
Saint Joseph Mercy Hospital
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Ann ArborUnited StatesUnknown status
University Of Michigan Comprehensive Cancer Center
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Ann ArborUnited StatesUnknown status
University of Colorado Hospital
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AuroraUnited StatesUnknown status
Johns Hopkins University/Sidney Kimmel Cancer Center
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BaltimoreUnited StatesUnknown status
Memorial Sloan Kettering Basking Ridge
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Basking RidgeUnited StatesUnknown status
Indu and Raj Soin Medical Center
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BeavercreekUnited StatesUnknown status
Prisma Health Cancer Institute - Spartanburg
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Boiling SpringsUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Boise
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BoiseUnited StatesUnknown status
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesUnknown status
Brigham and Women's Hospital
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BostonUnited StatesUnknown status
Henry Ford Cancer Institute-Downriver
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BrownstownUnited StatesUnknown status
Roswell Park Cancer Institute
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BuffaloUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Caldwell
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CaldwellUnited StatesUnknown status
Saint Francis Medical Center
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Cape GirardeauUnited StatesUnknown status
Centralia Oncology Clinic
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CentraliaUnited StatesUnknown status
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesUnknown status
Ralph H. Johnson VA Medical Center
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CharlestonUnited StatesUnknown status
University of Illinois
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ChicagoUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Marshfield Clinic-Chippewa Center
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Chippewa FallsUnited StatesUnknown status
Prisma Health Cancer Institute - Laurens
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ClintonUnited StatesUnknown status
Henry Ford Macomb Hospital-Clinton Township
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Clinton TownshipUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesUnknown status
Memorial Sloan Kettering Commack
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CommackUnited StatesUnknown status
Bay Area Hospital
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Coos BayUnited StatesUnknown status
UT Southwestern/Simmons Cancer Center-Dallas
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DallasUnited StatesUnknown status
Carle on Vermilion
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DanvilleUnited StatesUnknown status
Henry Ford Medical Center-Fairlane
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DearbornUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Atlanta VA Medical Center
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DecaturUnited StatesUnknown status
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
Prisma Health Cancer Institute - Easley
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EasleyUnited StatesUnknown status
Memorial Sloan Kettering Westchester
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East White PlainsUnited StatesUnknown status
Marshfield Medical Center-EC Cancer Center
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Eau ClaireUnited StatesUnknown status
Crossroads Cancer Center
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EffinghamUnited StatesUnknown status
Carle Physician Group-Effingham
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EffinghamUnited StatesUnknown status
Arnot Ogden Medical Center/Falck Cancer Center
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ElmiraUnited StatesUnknown status
Englewood Hospital and Medical Center
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EnglewoodUnited StatesUnknown status
Farmington Health Center
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FarmingtonUnited StatesUnknown status
Saint Luke's Cancer Institute - Fruitland
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FruitlandUnited StatesUnknown status
University of Florida Health Science Center - Gainesville
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GainesvilleUnited StatesUnknown status
University of Texas Medical Branch
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GalvestonUnited StatesUnknown status
Banner MD Anderson Cancer Center
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GilbertUnited StatesUnknown status
Benefis Healthcare- Sletten Cancer Institute
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Great FallsUnited StatesUnknown status
Prisma Health Cancer Institute - Butternut
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Faris
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GreenvilleUnited StatesUnknown status
Prisma Health Greenville Memorial Hospital
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Eastside
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Greer
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GreerUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada - Henderson
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HendersonUnited StatesUnknown status
Las Vegas Urology - Pebble
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HendersonUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada-Horizon Ridge
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HendersonUnited StatesUnknown status
Urology Specialists of Nevada - Green Valley
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HendersonUnited StatesUnknown status
OptumCare Cancer Care at Seven Hills
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HendersonUnited StatesUnknown status
Las Vegas Urology - Green Valley
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HendersonUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada-Southeast Henderson
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HendersonUnited StatesUnknown status
Island Urology-Hilo
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HiloUnited StatesUnknown status
Queen's Cancer Center - Kuakini
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HonoluluUnited StatesUnknown status
Queen's Cancer Cenrer - POB I
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HonoluluUnited StatesUnknown status
Straub Clinic and Hospital
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HonoluluUnited StatesUnknown status
Hawaii Cancer Care Inc - Waterfront Plaza
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HonoluluUnited StatesUnknown status
University of Hawaii Cancer Center
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HonoluluUnited StatesUnknown status
Island Urology
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HonoluluUnited StatesUnknown status
Queen's Medical Center
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HonoluluUnited StatesUnknown status
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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HoustonUnited StatesUnknown status
M D Anderson Cancer Center
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HoustonUnited StatesUnknown status
Houston Methodist Hospital
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HoustonUnited StatesUnknown status
University of Iowa/Holden Comprehensive Cancer Center
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Iowa CityUnited StatesUnknown status
Baptist MD Anderson Cancer Center
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JacksonvilleUnited StatesUnknown status
Kettering Medical Center
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KetteringUnited StatesUnknown status
Gundersen Lutheran Medical Center
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La CrosseUnited StatesUnknown status
Marshfield Clinic - Ladysmith Center
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LadysmithUnited StatesUnknown status
Sparrow Hospital
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LansingUnited StatesUnknown status
Radiation Oncology Centers of Nevada Central
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Las VegasUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada - Town Center
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Las VegasUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada - Northwest
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Las VegasUnited StatesUnknown status
Hope Cancer Care of Nevada
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Las VegasUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada
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Las VegasUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada-Summerlin
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Las VegasUnited StatesUnknown status
Las Vegas Urology - Cathedral Rock
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Las VegasUnited StatesUnknown status
OptumCare Cancer Care at Fort Apache
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Las VegasUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada - Central Valley
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Las VegasUnited StatesUnknown status
Urology Specialists of Nevada - Central
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Las VegasUnited StatesUnknown status
OptumCare Cancer Care at Oakey
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Las VegasUnited StatesUnknown status
Urology Specialists of Nevada - Northwest
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Las VegasUnited StatesUnknown status
Las Vegas Urology - Pecos
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Las VegasUnited StatesUnknown status
OptumCare Cancer Care at MountainView
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Las VegasUnited StatesUnknown status
Urology Specialists of Nevada - Southwest
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Las VegasUnited StatesUnknown status
Las Vegas Urology - Smoke Ranch
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Las VegasUnited StatesUnknown status
Las Vegas Prostate Cancer Center
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Las VegasUnited StatesUnknown status
Las Vegas Urology - Sunset
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Las VegasUnited StatesUnknown status
UTMB Cancer Center at Victory Lakes
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League CityUnited StatesUnknown status
Los Angeles County-USC Medical Center
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Los AngelesUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesUnknown status
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
Rogue Valley Medical Center
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MedfordUnited StatesUnknown status
Saint Luke's Cancer Institute - Meridian
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MeridianUnited StatesUnknown status
LSU Healthcare Network / Metairie Multi-Specialty Clinic
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MetairieUnited StatesUnknown status
East Jefferson General Hospital
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MetairieUnited StatesUnknown status
Memorial Sloan Kettering Monmouth
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MiddletownUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Marshfield Clinic-Minocqua Center
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MinocquaUnited StatesUnknown status
University of South Alabama Mitchell Cancer Institute
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MobileUnited StatesUnknown status
West Virginia University Healthcare
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MorgantownUnited StatesUnknown status
Good Samaritan Regional Health Center
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Mount VernonUnited StatesUnknown status
Saint Alphonsus Medical Center-Nampa
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NampaUnited StatesUnknown status
Saint Luke's Cancer Institute - Nampa
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NampaUnited StatesUnknown status
Yale University
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New HavenUnited StatesUnknown status
Smilow Cancer Center/Yale-New Haven Hospital
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New HavenUnited StatesUnknown status
Louisiana State University Health Science Center
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New OrleansUnited StatesUnknown status
Ochsner Medical Center Jefferson
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New OrleansUnited StatesUnknown status
University Medical Center New Orleans
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New OrleansUnited StatesUnknown status
Laura and Isaac Perlmutter Cancer Center at NYU Langone
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Henry Ford Medical Center-Columbus
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NoviUnited StatesUnknown status
Kaiser Permanente-Oakland
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OaklandUnited StatesUnknown status
Cancer Care Center of O'Fallon
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O'FallonUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Mercy Hospital Oklahoma City
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Oklahoma CityUnited StatesUnknown status
Saint Alphonsus Medical Center-Ontario
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OntarioUnited StatesUnknown status
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesUnknown status
Stanford Cancer Institute Palo Alto
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Palo AltoUnited StatesUnknown status
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesUnknown status
Mayo Clinic Hospital in Arizona
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PhoenixUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Portland VA Medical Center
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PortlandUnited StatesUnknown status
Renown Regional Medical Center
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RenoUnited StatesUnknown status
Marshfield Medical Center-Rice Lake
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Rice LakeUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
Kaiser Permanente-South Sacramento
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SacramentoUnited StatesUnknown status
Huntsman Cancer Institute/University of Utah
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Salt Lake CityUnited StatesUnknown status
University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesUnknown status
Audie L Murphy VA Hospital
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San AntonioUnited StatesUnknown status
University Hospital
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San AntonioUnited StatesUnknown status
UCSF Medical Center-Mission Bay
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San FranciscoUnited StatesUnknown status
Mayo Clinic in Arizona
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ScottsdaleUnited StatesUnknown status
University of Washington Medical Center - Montlake
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SeattleUnited StatesUnknown status
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesUnknown status
Seattle Cancer Care Alliance
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SeattleUnited StatesUnknown status
Prisma Health Cancer Institute - Seneca
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SenecaUnited StatesUnknown status
LSU Health Sciences Center at Shreveport
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ShreveportUnited StatesUnknown status
South Jordan Health Center
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South JordanUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
Memorial Medical Center
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SpringfieldUnited StatesUnknown status
Mercy Hospital Springfield
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SpringfieldUnited StatesUnknown status
Springfield Clinic
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SpringfieldUnited StatesUnknown status
Marshfield Clinic Stevens Point Center
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Stevens PointUnited StatesUnknown status
Mercy Hospital Saint Louis
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St LouisUnited StatesUnknown status
State University of New York Upstate Medical University
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SyracuseUnited StatesUnknown status
Madigan Army Medical Center
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TacomaUnited StatesUnknown status
Moffitt Cancer Center - McKinley Campus
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TampaUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status
Saint Luke's Cancer Institute - Twin Falls
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Twin FallsUnited StatesUnknown status
Memorial Sloan Kettering Nassau
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UniondaleUnited StatesUnknown status
The Carle Foundation Hospital
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UrbanaUnited StatesUnknown status
Carle Cancer Center
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UrbanaUnited StatesUnknown status
Kaiser Permanente-Vallejo
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VallejoUnited StatesUnknown status
Kaiser Permanente-Walnut Creek
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Walnut CreekUnited StatesUnknown status
Saint John Macomb-Oakland Hospital
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WarrenUnited StatesUnknown status
George Washington University Medical Center
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Washington D.C.United StatesUnknown status
MedStar Washington Hospital Center
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Washington D.C.United StatesUnknown status
Marshfield Clinic-Wausau Center
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WausauUnited StatesUnknown status
Henry Ford West Bloomfield Hospital
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West BloomfieldUnited StatesUnknown status
Marshfield Medical Center - Weston
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WestonUnited StatesUnknown status
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesUnknown status
Marshfield Clinic - Wisconsin Rapids Center
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Wisconsin RapidsUnited StatesUnknown status

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