Status:
RECRUITING
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Lead Sponsor:
Early is Good Inc.
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
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...
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 recurren...
Eligibility Criteria
Inclusion
- 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
- Patients planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma.
Key Trial Info
Start Date :
July 26 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05982561
Start Date
July 26 2023
End Date
December 31 2025
Last Update
April 10 2024
Active Locations (3)
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1
Arkansas Urology Research Center
Little Rock, Arkansas, United States, 72211
2
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
3
Washington University
St Louis, Missouri, United States, 63130