A test to predict response to bladder cancer treatment
A Novel Multiplex Immunoassay for Predicting Intravesical BCG Response in Patients With Intermediate or High-risk Non-muscle Invasive Bladder Cancer
Cedars-Sinai Medical Center · NCT04564781
This study is testing a new urine test to see if it can help predict which bladder cancer patients will benefit from a specific treatment called BCG therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center (other) |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT04564781 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a urine-based diagnostic tool that can accurately predict which patients with bladder cancer will respond favorably to intravesical Bacillus Calmette-Guérin (BCG) therapy. Currently, there are no reliable diagnostics available, leading to a high failure rate of nearly 50% among patients treated with BCG. The study will involve patients who have been diagnosed with specific stages of urothelial cell carcinoma and have undergone necessary preliminary treatments. By identifying responders, the study seeks to improve treatment outcomes and reduce unnecessary procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with specific stages of bladder cancer who are scheduled to receive BCG treatment.
Not a fit: Patients with pure squamous cell carcinoma or adenocarcinoma, or those with upper tract cancer, will not benefit from this study.
Why it matters
Potential benefit: If successful, this diagnostic tool could significantly improve treatment outcomes for bladder cancer patients by identifying those who are likely to benefit from BCG therapy.
How similar studies have performed: While there is a significant need for predictive diagnostics in bladder cancer treatment, this specific approach appears to be novel and untested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder diagnosed within 90 days prior to scheduled BCG * Patients must have had all grossly visible papillary tumors removed within 30 days prior to scheduled BCG or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to scheduled BCG * Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of nodal involvement or metastatic disease (CT scan or MRI scan) within 90 days prior to scheduled BCG * Patients must have intermediate or high-grade bladder cancer as defined by 2004 WHO/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 BCG: CT urogram, intravenous pyelogram, MR urogram, or retrograde pyelograms. * No other prior non-bladder 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. * Participants may be treated with immediate post-operative intravesical instillation of a chemotherapeutic agent * Scheduled to undergo intravesical BCG therapy within 4 weeks of signing consent. * Willing and able to give written informed consent (see Appendix 1) * Willing to provide voided urine sample Exclusion Criteria: * Previous intravesical BCG therapy * 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. * Patients must not have known history of tuberculosis. * Have incomplete TUR, i.e., visible residual disease * Have had radical cystectomy * Have a known active urinary tract infection or urinary retention * Have active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwise repeat. * Have ureteral stents, nephrostomy tubes or bowel interposition * Have recent genitourinary instrumentation (within 7 days prior to signing consent) * Be unable or unwilling to complete BCG induction and maintenance regimen
Where this trial is running
Los Angeles, California and 4 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
- UCLA — Los Angeles, California, United States (RECRUITING)
- UCSF — San Francisco, California, United States (RECRUITING)
- University of Texas Southwestern — Dallas, Texas, United States (RECRUITING)
- Kyoto University — Kyoto, Kyoto, Japan (RECRUITING)
Study contacts
- Principal investigator: Hideki Furuya, PhD — Cedars-Sinai Medical Center
- Study coordinator: Charles Rosser, MD
- Email: Charles.rosser@cshs.org
- Phone: 3104233713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bladder Cancer