Predicting BCG Response

Description

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

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Study Overview

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Study Details

Study overview

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.

A Novel Multiplex Immunoassay for Predicting Intravesical BCG Response in Patients With Intermediate or High-risk Non-muscle Invasive Bladder Cancer

Predicting BCG Response

Condition
Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Los Angeles

UCLA, Los Angeles, California, United States, 90095

San Francisco

UCSF, San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cedars-Sinai Medical Center,

Charles Rosser, MD, STUDY_DIRECTOR, Nonagen Bioscience Corporation

Hideki Furuya, PhD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

2026-12-30