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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Early is Good Inc.
Study ID
NCT05982561
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 NMIBC, offering a noninvasive monitoring solution.

Key Dates

Start date
Jul 26, 2023
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
500 participants (estimated)

Primary Outcome Measure

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) [ Time Frame: Participants' urine samples will be collected before cystoscopy and analyzed using the BCDx test within 6 months to establish its overall performance characteristics. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Arkansas Urology Research CenterLittle RockArkansas72211
Marotte,
Jeff Marotte, MD (PRINCIPAL_INVESTIGATOR)
Indiana University School of MedicineIndianapolisIndiana46202
Hristos Kaimakliotis, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63130
Eric Kim, MD (PRINCIPAL_INVESTIGATOR)
Zeynep G. Gul, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Little Rock, AR

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Arkansas Urology Research Center· Little Rock, ARIndiana University School of Medicine· Indianapolis, INWashington University· St Louis, MO

Related Studies