Urine test for monitoring bladder cancer recurrence
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Early is Good Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Little Rock, Arkansas and 2 other locations) |
| Trial ID | NCT05982561 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of NMIBC who are undergoing routine cystoscopy monitoring.
Not a fit: Patients planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma may not benefit from this study.
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 performed: Other studies have explored noninvasive monitoring methods for bladder cancer, but the specific multi-omic approach of BCDx is novel.
Eligibility criteria
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 this trial is running
Little Rock, Arkansas and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.