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Predicting Response to BCG for Bladder Cancer

This observational study is looking for a better way to predict how well people with bladder cancer will respond to a treatment called BCG (Bacillus Calmette-Guérin). Currently, it's hard to know who will benefit from BCG, and many patients end up needing more treatment or surgery. This study aims to confirm the accuracy of a special test (multiplex immunoassay) that looks at different markers to see if it can successfully identify patients who will respond well to BCG. You may be able to join if you are 18 to 90 years old, have a specific type of bladder cancer (Ta, carcinoma in situ (CIS), or T1 stage urothelial cell carcinoma) diagnosed within 90 days before your scheduled BCG treatment, and have had any visible tumors removed. The study will track how well this test predicts response until April 30, 2027.

Study design
This is an observational study with a planned enrollment of 400 participants. It is not a randomized study, meaning participants are not assigned to different treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the accuracy of the test until April 30, 2027.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04564781

Predicting BCG Response

Recruiting
Not specifiedAges 18–90Observational
Cedars-Sinai Medical Center
~400 participants
Updated 2026-07-06 on ClinicalTrials.gov

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and specificity of multiplex immunoassay will be confirmed by surveillance cystoscopy.
Measured over present through 04/30/2027

Conditions

Bladder Cancer

Explore related trials

Bladder Carcinoma

NCT04564781

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cedars-Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • University of Queensland

    Brisbane, Australiastudy coordinator listed

    Recruiting

  • University of Texas Southwestern

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Kyoto University

    Kyoto, Japanno site contact published

    Recruiting

  • UCLA

    Los Angeles, Californiano site contact published

    Recruiting

  • UCSF

    San Francisco, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Charles Rosser, MD · STUDY_DIRECTOR · Nonagen Bioscience Corporation
  • Hideki Furuya, PhD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Charles Rosser, MD
[email protected]
3104233713
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Sensitivity and specificity of multiplex immunoassay will be confirmed by surveillance cystoscopy.present through 04/30/2027