Clincosm LogoSign in Get a demo

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

Sponsor
Early is Good Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05982561
Collaborator
(none)
500
Enrollment
3
Locations
29.2
Anticipated Duration (Months)
166.7
Patients Per Site
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
    Actual Study Start Date :
    Jul 26, 2023
    Anticipated Primary Completion Date :
    Jul 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients 22 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 40mL of voided urine.

    Exclusion Criteria:
    • Patients planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arkansas Urology Research Center Little Rock Arkansas United States 72211
    2 Indiana University School of Medicine Indianapolis Indiana United States 46202
    3 Washington University Saint Louis Missouri United States 63130

    Sponsors and Collaborators

    • Early is Good Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Early is Good Inc.
    ClinicalTrials.gov Identifier:
    NCT05982561
    Other Study ID Numbers:
    • EIG 2023-02
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 8, 2023
    Last Verified:
    Aug 1, 2023
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms
    Non-Muscle Invasive Bladder Neoplasms
    Recurrence

    Study Results

    No Results Posted as of Aug 8, 2023