BCG Prediction Assay, multiplex immunoassay for predicting intravesical BCG response

What is the Purpose of this Study?

1.To examine the sensitivity and specificity of the multiplex immunoassay directed at a bladder cancer-associated signature in voided urine samples ability s to predict treatment response in patients with intermediate/high risk NMIBC treated with intravesical BCG. 2.To compare the sensitivity and specificity of the multiplex immunoassay to a panel of 12 cytokines ( IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17, TNF-α, granulocyte-macrophage colony-stimulating factor (GM-CSF) and interferon (IFN)-γ) ability to predict treatment response in patients with intermediate/high risk NMIBC treated with intravesical BCG. 3.To develop a BCG prediction risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data.

Eligibility

* 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

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

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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center

More about this Clinical Trial

What is the full name of this clinical trial?

IIT-BCGPREDICTIONASSAY: BCG Prediction Assay: A Novel Multiplex Immunoassay for Predicting Intravesical BCG Response in Patients with Intermediate or High-Risk Non-Muscle InvasIVe Bladder Cancer

Study Details

Disease Type/Condition

Urinary Bladder

Principal Investigator

Furuya, Hideki

Co-Investigators

Charles Rosser

Age Group

Adult

Phase

III (Cancer Control)

IRB Number

STUDY00000914

ClinicalTrials.gov ID

NCT04564781

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org