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

Recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT05982561
• Lead Sponsor: Early is Good Inc.

Brief 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.

Study Timeline

• Study Start: 2023-07-26
• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-08-06
• Study First Posted: 2023-08-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of BCDx (the proportion of negatives that are correctly identified as such by the gold standard)	Participants' urine samples will be collected before cystoscopy and analyzed using the BCDx test within 6 months to establish its overall performance characteristics.

Trial Locations

Locations (3)

Arkansas Urology Research Center; 🇺🇸 Little Rock, Arkansas, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States