Recruiting

BCDx

Sponsor:

Early is Good Inc.

Code:

NCT05982561

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Bladder Cancer

Study ID

NCT05982561

Start date

Jul 26, 2023

Status verified date

Apr, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

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 and Locations

Central contacts

Thakshila Liyanage, PhD

(317) 941-6953thakshila@earlyisgood.com

Locations

Arkansas Urology Research Center

Recruiting

Little Rock, Arkansas, United States, 72211

Principal Investigator:

Jeff Marotte, MD

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Hristos Kaimakliotis, MD

Washington University

Recruiting

St Louis, Missouri, United States, 63130

Principal Investigator:

Eric Kim, MD

More Information

Sponsor

Early is Good Inc.

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Early is Good Inc. on 2026-04-23.