NCT05982561Recruiting

Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer

Early is Good Inc.

Start Date

7/26/2023

Completion Date

8/31/2026

Summary

BCDx is a urine-based multi-omic assay for early cancer recurrence detection in patients with a history of bladder cancer. This prospective, blinded study evaluates its efficacy in detecting recurrent NMIBC, offering a noninvasive monitoring solution.

Detailed Description

BCDx is a urine-based multi-omic/multiplex molecular assay offers a promising solution for detecting cancer recurrence. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer. This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel multi-omics test for the detection of recurrent NMIBC in patients with a history of bladder cancer undergoing surveillance.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Patients 18 Years and older * Patients who have been diagnosed with incident or recurrent NMIBC within the past 2 years and undergoing standard of care/routine monitoring cystoscopy. * Patients who are able to provide legally effective informed consent. * Patients who are able to provide minimum 30mL of voided urine. Exclusion Criteria: * Patients planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma.

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Conditions

Bladder Cancer

Locations

Arkansas Urology Research Center

Little Rock, Arkansas 72211

United States

Indiana University School of Medicine

Indianapolis, Indiana 46202

United States

Washington University

St Louis, Missouri 63130

United States