Clinical trial Recruiting at 3 sites Observational Ages 18 and up

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.

More Bladder Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorEarly is Good Inc.
Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations3 sites (Little Rock, Arkansas and 2 other locations)
StatusRecruiting
StartedJuly 26, 2023
Main results expectedAugust 31, 2026
Study endsAugust 31, 2026
Registry record updatedApril 23, 2026
Trial IDNCT05982561 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.