Urine test for monitoring bladder cancer recurrence
Official title: Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Run by Early is Good Inc. · NCT05982561 · Data updated 2026-11-12
This study is testing a new urine test to see if it can help people with a history of bladder cancer find out sooner if their cancer comes back, without needing invasive procedures.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Early is Good Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Little Rock, Arkansas and 2 other locations) |
| Status | Recruiting |
| Started | July 26, 2023 |
| Main results expected | August 31, 2026 |
| Study ends | August 31, 2026 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT05982561 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a history of NMIBC who are undergoing routine cystoscopy monitoring.
✕Probably not a fit
Patients planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the efficacy of BCDx, a urine-based multi-omic assay, for detecting recurrence in patients with non-muscle invasive bladder cancer (NMIBC). The study is prospective and blinded, involving multiple centers to assess the sensitivity and specificity of this noninvasive monitoring solution. Patients with a history of bladder cancer will provide urine samples for analysis alongside routine cystoscopy monitoring. The goal is to improve early detection of cancer recurrence without the need for invasive procedures.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more efficient method for monitoring bladder cancer recurrence.
How similar studies have gone: Other studies have explored noninvasive monitoring methods for bladder cancer, but the specific multi-omic approach of BCDx is novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Arkansas Urology Research Center
Little Rock, Arkansas, United States Recruiting -
Indiana University School of Medicine
Indianapolis, Indiana, United States Recruiting -
Washington University
St Louis, Missouri, United States Recruiting
Study contacts
- Study coordinator: Thakshila Liyanage, PhD
- Email: thakshila@earlyisgood.com
- Phone: (317) 941-6953
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.