Predicting BCG Response (NCT04564781)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (12 items).
Location: Cedars-Sinai Medical Center — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 Sites)
- Cedars-Sinai Medical Center — Los Angeles, California
- UCLA — Los Angeles, California
- UCSF — San Francisco, California
- University of Texas Southwestern — Dallas, Texas
- University of Queensland — Brisbane,
- Kyoto University — Kyoto,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.