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Brief Title: Predicting BCG Response

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

INTRODUCTION

  • Org Study ID: CR2020-1113-0
  • Secondary ID: N/A
  • NTC ID: NCT04564781
  • Sponsor: Cedars-Sinai Medical Center

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.


  • Overall Status
    Recruiting
  • Start Date
    September 18, 2020
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Sensitivity and specificity of multiplex immunoassay will be confirmed by surveillance cystoscopy.

Primary Outcome 1 - Timeframe: present through 04/30/2026

CONDITION

  • Bladder Cancer

ELIGIBILITY


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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: Cedars-Sinai Medical Center
Los Angeles, California 90048
United States 		Status: Recruiting Contact:
Amy Oppenheim
310-423-3713
Amy.Oppenheim@cshs.org

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