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BCDx for Monitoring Bladder Cancer Recurrence

This study is evaluating a new urine test called BCDx. It's designed to help doctors monitor for bladder cancer recurrence (when cancer comes back) in patients who have already been diagnosed with non-muscle invasive bladder cancer (NMIBC). The study aims to see how well BCDx can correctly identify recurrence, compared to standard methods like cystoscopy. You might be able to join if you are 18 or older, have been diagnosed with NMIBC within the last two years, and are undergoing routine monitoring. The study is looking for 500 participants.

Study design
This is an observational, multicenter, prospective, and blinded study involving 500 participants.
What's involved
Participants will provide a minimum of 30mL of voided urine before their cystoscopy. Urine samples will be analyzed using the BCDx test within 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants' urine samples will be collected and analyzed within 6 months to establish the test's performance characteristics.

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NCT05982561

Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer

Recruiting
Not specifiedAges 18+Observational
Early is Good Inc.
~500 participants
Updated 2026-04-23 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of BCDx (the proportion of negatives that are correctly identified as such by the gold standard)
Measured over Participants' urine samples will be collected before cystoscopy and analyzed using the BCDx test within 6 months to establish its overall performance characteristics.

Conditions

Bladder Cancer

Explore related trials

Non-Muscle Invasive Bladder Carcinoma

NCT05982561

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arkansas Urology Research Center

    Little Rock, Arkansasno site contact published

    Recruiting

  • Indiana University School of Medicine

    Indianapolis, Indianano site contact published

    Recruiting

  • Washington University

    St Louis, Missourino site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Thakshila Liyanage, PhD
[email protected]
(317) 941-6953
Email the study team

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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.

What this trial measures

  • Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of BCDx (the proportion of negatives that are correctly identified as such by the gold standard)Participants' urine samples will be collected before cystoscopy and analyzed using the BCDx test within 6 months to establish its overall performance characteristics.