Actively Recruiting
Predicting BCG Response
Led by Cedars-Sinai Medical Center · Updated on 2026-02-04
400
Participants Needed
5
Research Sites
489 weeks
Total Duration
On this page
Sponsors
C
Cedars-Sinai Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
To date, there are no diagnostics capable of predicting treatment response to intravesical BCG. Because of this severe limitation, nearly 50% of patients treated with BCG fail therapy and will a) require additional intravesical therapy or b) require cystectomy. A urine-based diagnostic that possesses the potential to accurately identify patients who will respond favorably to intravesical BCG is desperately needed.
CONDITIONS
Official Title
Predicting BCG Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically proven Ta, carcinoma in situ (CIS), or T1 stage urothelial bladder cancer diagnosed within 90 days prior to scheduled BCG
- All visible papillary tumors removed or cystoscopy confirming no visible tumors within 30 days prior to scheduled BCG
- For T1 disease, recent cross-sectional imaging showing no nodal involvement or metastatic disease within 90 days prior to scheduled BCG
- Intermediate or high-grade bladder cancer as defined by 2004 WHO/ISUP classification
- No pure squamous cell carcinoma or adenocarcinoma
- No micropapillary components in disease
- No evidence of upper tract cancer confirmed by imaging within 90 days prior to BCG
- No other prior non-bladder malignancy except adequately treated skin cancer, in situ cervical cancer, or certain other cancers in remission
- Patients with localized prostate cancer under active surveillance are eligible
- May have immediate post-operative intravesical instillation of chemotherapy
- Scheduled to receive intravesical BCG within 4 weeks of consent
- Willing and able to provide informed consent and voided urine sample
You will not qualify if you...
- Previous intravesical BCG therapy
- Currently taking oral glucocorticoids
- Planning to receive other cancer therapies concurrently with the study
- Known history of tuberculosis
- Incomplete tumor resection with visible residual disease
- Have had radical cystectomy
- Active urinary tract infection or urinary retention
- Active kidney or bladder stone disease or renal insufficiency (creatinine >2.0 mg/dL)
- Presence of ureteral stents, nephrostomy tubes, or bowel interposition
- Recent genitourinary instrumentation within 7 days prior to consent
- Unable or unwilling to complete BCG induction and maintenance regimen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
3
UCSF
San Francisco, California, United States, 94143
Actively Recruiting
4
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
5
Kyoto University
Kyoto, Kyoto, Japan, 606-8501
Actively Recruiting
Research Team
C
Charles Rosser, MD
CONTACT
A
Amy Oppenheimer
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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