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

RECRUITINGSponsored by Early is Good Inc.
Actively Recruiting
SponsorEarly is Good Inc.
Started2023-07-26
Est. completion2025-07-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites

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.

Eligibility

Age: 18 Years+Healthy volunteers 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.

Conditions2

Bladder CancerCancer

Locations3 sites

Arkansas

1 site
Arkansas Urology Research Center
Little Rock, Arkansas, 72211
Marotte,

Indiana

1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Hristos Kaimakliotis, MD

Missouri

1 site
Washington University
St Louis, Missouri, 63130
Eric Kim, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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