Clinical trial NCT04564781: Predicting BCG Response
Official title: A Novel Multiplex Immunoassay for Predicting Intravesical BCG Response in Patients With Intermediate or High-risk Non-muscle Invasive Bladder Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Nonagen Bioscience Corporation
name: University of California, San Francisco
name: Kyoto University
name: University of California, Los Angeles
First posted: 2020-09-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of multiplex immunoassay will be confirmed by surveillance cystoscopy.
timeFrame: present through 04/30/2027
Secondary outcomes:
measure: Sensitivity and specificity of multiplex immunoassay will be compared to panel of urinary cytokines.
timeFrame: present through 04/30/2027
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Kyoto
country: Japan
facility: Kyoto University
Study officials:
affiliation: Nonagen Bioscience Corporation
name: Charles Rosser, MD
role: STUDY_DIRECTOR
affiliation: Cedars-Sinai Medical Center
name: Hideki Furuya, PhD
role: PRINCIPAL_INVESTIGATOR
References: