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Predicting BCG Response

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04564781
Collaborator
National Cancer Institute (NCI) (NIH), Nonagen Bioscience Corporation (Industry), University of California, San Francisco (Other), University of Rochester (Other), Kyoto University (Other)
400
Enrollment
1
Location
75.4
Anticipated Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Novel Multiplex Immunoassay for Predicting Intravesical BCG Response in Patients With Intermediate or High-risk Non-muscle Invasive Bladder Cancer
    Actual Study Start Date :
    Sep 18, 2020
    Anticipated Primary Completion Date :
    Apr 30, 2026
    Anticipated Study Completion Date :
    Dec 30, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and specificity of multiplex immunoassay will be confirmed by surveillance cystoscopy. [present through 04/30/2026]

    Secondary Outcome Measures

    1. Sensitivity and specificity of multiplex immunoassay will be compared to panel of urinary cytokines. [present through 04/30/2026]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center Los Angeles California United States 90048

    Sponsors and Collaborators

    • Cedars-Sinai Medical Center
    • National Cancer Institute (NCI)
    • Nonagen Bioscience Corporation
    • University of California, San Francisco
    • University of Rochester
    • Kyoto University

    Investigators

    • Study Director: Charles Rosser, MD, Nonagen Bioscience Corporation
    • Principal Investigator: Amit Gupta, MD, Cedars-Sinai Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cedars-Sinai Medical Center
    ClinicalTrials.gov Identifier:
    NCT04564781
    Other Study ID Numbers:
    • CR2020-1113-0
    First Posted:
    Sep 25, 2020
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Mar 21, 2022