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Recruiting NCT05982561
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Trial Parameters
Condition Bladder Cancer
Sponsor Early is Good Inc.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-07-26
Completion 2025-07-31
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.
Eligibility Criteria
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.