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

April 20, 2026 updated by: Early is Good Inc.
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

BCDx is a urine-based multi-omic/multiplex molecular assay offers a promising solution for detecting cancer recurrence. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer. This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel multi-omics test for the detection of recurrent NMIBC in patients with a history of bladder cancer undergoing surveillance.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Arkansas Urology Research Center
        • Contact:
          • Marotte,
        • Principal Investigator:
          • Jeff Marotte, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine
        • Principal Investigator:
          • Hristos Kaimakliotis, MD
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Recruiting
        • Washington University
        • Principal Investigator:
          • Eric Kim, MD
        • Principal Investigator:
          • Zeynep G. Gul, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cystoscopic surveillance for non-muscle invasive bladder cancer (NMIBC) follow-up.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Early is Good Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

August 6, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIG 2023-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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