Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
870 participants
INTERVENTIONAL
2023-02-07
2030-10-31
Brief Summary
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Bacillus Calmette-Guérin (BCG) and Gemcitabine in People With High-Grade Non-Muscle Invasive Bladder Cancer That Came Back After BCG Treatment
NCT04179162
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NCT05644041
Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer
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Gemcitabine and Docetaxel Therapy in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Gemcitabine + Docetaxel
Gemcitabine
Intravesical once a week for 6 consecutive weeks followed by monthly instillations during maintenance for 2 years
Docetaxel
Intravesical once a week for 6 consecutive weeks followed by monthly instillations during maintenance for 2 years
Arm B
BCG
Bacillus Calmette Guerin
intravesical once a week for 6 consecutive weeks during induction followed by weekly instillations for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 months
Interventions
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Gemcitabine
Intravesical once a week for 6 consecutive weeks followed by monthly instillations during maintenance for 2 years
Docetaxel
Intravesical once a week for 6 consecutive weeks followed by monthly instillations during maintenance for 2 years
Bacillus Calmette Guerin
intravesical once a week for 6 consecutive weeks during induction followed by weekly instillations for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage) on transurethral resection of bladder tumor (TURBT) obtained within 90 days prior to randomization.
* Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization. If the treating urologist did not perform the TURBT as outlined in Section 3.1.3, the treating urologist must perform a cystoscopy within 28 days prior to randomization to confirm the absence of visible papillary disease.
* Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT.
* Patients with high grade T1 disease must have undergone a restaging TURBT within 90 days prior to Step 1 randomization.
NOTE: Patients with high grade T1 disease who undergo a restaging TURBT that shows no residual cancer in the restaging TURBT specimen are eligible.
* Patient must not have pure squamous cell carcinoma or adenocarcinoma.
* Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell).
* Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Patient must have ECOG Performance Status 0-2.
* Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy.
* 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 adequate organ and marrow function as defined below (these labs must be obtained ≤ 28 days prior to randomization):
Leukocytes ≥ 3,000/mcL Leukocytes:\_\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_\_\_\_ Absolute neutrophil count (ANC) ≥ 1,500/mcL ANC:\_\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_\_\_\_ Platelets ≥ 70,000/mcL Platelets:\_\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_\_\_\_ Total Bilirubin ≤ institutional upper limit of normal (ULN) Total Bilirubin:\_\_\_\_\_\_\_\_\_\_ Institutional ULN:\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_\_\_\_ AST(SGOT)/ALT(SGPT) ≤ 3.0 × institutional ULN AST:\_\_\_\_\_\_\_ Institutional ULN:\_\_\_\_\_\_\_\_\_ Date of Test:\_\_\_\_\_\_\_ ALT: \_\_\_\_\_\_\_Institutional ULN:\_\_\_\_\_\_\_\_\_
* 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.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Patients with 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.
Exclusion Criteria
NOTE: If a patient's renal function does not permit the administration of intravenous contrast, either a CT scan or MRI of the abdomen/pelvis without intravenous contrast is acceptable.
NOTE: Patients with a history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e., either cytology, biopsy, or imaging) that demonstrates no evidence of residual disease are eligible.
\- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.
A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Patient of child bearing potential? \_\_\_\_\_\_ (Yes or No) Date of blood test or urine study: \_\_\_\_\_\_\_\_\_\_\_
* Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. In addition,patients on Arm A must continue contraception measures for six months after the last dose of GEMDOCE for patients of child-bearing potential and continue for three month after the last dose of GEMDOC for male patients with partners of child-bearing potential. All patients must not breastfeed during their time on protocol treatment.
* Patient must not have a history of severe hypersensitivity reactions to docetaxel or drugs formulated with polysorbate 80.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
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Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
CARTI Cancer Center
Little Rock, Arkansas, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
Mercy Cancer Center - Carmichael
Carmichael, California, United States
Mercy San Juan Medical Center
Carmichael, California, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Mercy Cancer Center
Merced, California, United States
Mercy Cancer Center - Rocklin
Rocklin, California, United States
Mercy Cancer Center - Sacramento
Sacramento, California, United States
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States
BASS Medical Group - Lennon
Walnut Creek, California, United States
Woodland Memorial Hospital
Woodland, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Boulder Community Foothills Hospital
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
Saint Francis Cancer Center
Colorado Springs, Colorado, United States
The Women's Imaging Center
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Southwest Oncology PC
Durango, Colorado, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Walter Knox Memorial Hospital
Emmett, Idaho, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Saint Anthony's Health
Alton, Illinois, United States
Saint Mary's Hospital
Centralia, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
North Shore Medical Center
Skokie, Illinois, United States
Reid Health
Richmond, Indiana, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic - Ames
Ames, Iowa, United States
McFarland Clinic - Boone
Boone, Iowa, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, United States
Flaget Memorial Hospital
Bardstown, Kentucky, United States
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, United States
Saint Joseph Hospital
Lexington, Kentucky, United States
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, United States
Saint Joseph Hospital East
Lexington, Kentucky, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Saint Joseph London
London, Kentucky, United States
Saint Joseph Mount Sterling
Mount Sterling, Kentucky, United States
Mercy Health - Paducah Cancer Center
Paducah, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States
Ochsner LSU Health - Cancer Treatment Center
Shreveport, Louisiana, United States
Maine Medical Partners Urology
South Portland, Maine, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
Cox Cancer Center Branson
Branson, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
Lake Regional Hospital
Osage Beach, Missouri, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Mercy Hospital Washington
Washington, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, United States
CHI Health Good Samaritan
Kearney, Nebraska, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Jersey City Medical Center
Jersey City, New Jersey, United States
Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Albany Medical Center
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
East White Plains, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, United States
Saint Elizabeth Boardman Hospital
Boardman, Ohio, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, United States
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, United States
Armes Family Cancer Center
Findlay, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Orion Cancer Care
Findlay, Ohio, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Greater Dayton Cancer Center
Kettering, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Dayton Physicians LLC - Troy
Troy, Ohio, United States
Saint Joseph Warren Hospital
Warren, Ohio, United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Portland VA Medical Center
Portland, Oregon, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center-Rockledge
Rockledge, Pennsylvania, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Ralph H Johnson VA Medical Center
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
MUSC Health Florence Medical Center
Florence, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Lexington Medical Center
West Columbia, South Carolina, United States
MD Anderson in The Woodlands
Conroe, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Michael E DeBakey VA Medical Center
Houston, Texas, United States
MD Anderson West Houston
Houston, Texas, United States
MD Anderson League City
League City, Texas, United States
UTMB Cancer Center at Victory Lakes
League City, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
Jefferson Healthcare
Port Townsend, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
FHCC South Lake Union
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Saint Michael Cancer Center
Silverdale, Washington, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, United States
Billings Clinic-Cody
Cody, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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References
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Koti M, Robert Siemens D. A Step Closer to Predicting Progression After Bacillus Calmette-Guerin Immunotherapy in High-risk Non-muscle-invasive Bladder Cancer. Eur Urol. 2023 Nov;84(5):447-448. doi: 10.1016/j.eururo.2023.06.017. Epub 2023 Jul 1.
Other Identifiers
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NCI-2022-04864
Identifier Type: OTHER
Identifier Source: secondary_id
EA8212
Identifier Type: -
Identifier Source: org_study_id
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