A test to predict response to bladder cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• University of Queensland
  Brisbane, Australia Recruiting
• Kyoto University
  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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.