Predicting BCG Response

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Charles Rosser, MD; Phone Number: 3104233713; Email: Charles.rosser@cshs.org
• Study Contact Backup: Name: Amy Oppenheimer; Phone Number: 3104233713; Email: Amy.Oppenheim@cshs.org

Study Locations

• Japan
  • Kyoto, Japan, 606-8501
    • Recruiting
    • Kyoto University
    • Contact: Yuki Kita, MD
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Amy Oppenheim; Phone Number: 310-423-3713; Email: Amy.Oppenheim@cshs.org
      • Principal Investigator: Hideki Furuya, PhD
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA
      • Contact: Arnold Chin, MD
    • San Francisco, California, United States, 94143
      • Recruiting
      • UCSF
      • Contact: Sima Porten, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with recently diagnosed intermediate or high risk non-muscle invasive bladder cancer, who are destined to undergo intravesical BCG therapy.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of multiplex immunoassay will be confirmed by surveillance cystoscopy.	present through 04/30/2026

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of multiplex immunoassay will be compared to panel of urinary cytokines.	present through 04/30/2026

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Cancer Institute (NCI); University of California, Los Angeles; University of California, San Francisco; Kyoto University; Nonagen Bioscience Corporation
• Investigators: Study Director: Charles Rosser, MD, Nonagen Bioscience Corporation; Principal Investigator: Hideki Furuya, PhD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2020
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: CR2020-1113-0; R01CA198887 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No