Recruiting

BCG Response

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT04564781

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Bladder Cancer

Study ID

NCT04564781

Start date

Sep 18, 2020

Status verified date

Jul, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Charles Rosser, MD

3104233713Charles.rosser@cshs.org

Amy Oppenheimer

3104233713Amy.Oppenheim@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Amy Oppenheim

310-423-3713Amy.Oppenheim@cshs.org

Principal Investigator:

Hideki Furuya, PhD

UCLA

Recruiting

Los Angeles, California, United States, 90095

UCSF

Recruiting

San Francisco, California, United States, 94143

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Perla Lopez

214-648-9195perla.lopez@utsouthwestern.edu

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-07-06.