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

Phase

N/A

Condition

Bladder Cancer

Urothelial Carcinoma

Urothelial Cancer

Treatment

N/A

Clinical Study ID

NCT05982561

EIG 2023-02

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients 18 Years and older
Patients who have been diagnosed with incident or recurrent NMIBC within the past 2years 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

Exclusion Criteria:

Patients planning to undergo radical cystectomy or chemotherapy-radiation forUrothelial Cell Carcinoma.

Study Design

July 26, 2023

December 31, 2025

Study 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.

Connect with a study center

Arkansas Urology Research Center
Little Rock, Arkansas 72211
United States
Active - Recruiting
Indiana University School of Medicine
Indianapolis, Indiana 46202
United States
Active - Recruiting
Washington University
Saint Louis, Missouri 63130
United States
Active - Recruiting

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