Bladder Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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.

Study is for people with:

Bladder Cancer

Estimated Enrollment:

500

Study ID:

NCT05982561

Recruitment Status:

Recruiting

Sponsor:

Early is Good Inc.

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There are 3 Locations for this study

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Arkansas Urology Research Center
Little Rock Arkansas, 72211, United States More Info
Marotte,
Contact
Jeff Marotte, MD
Principal Investigator
Indiana University School of Medicine
Indianapolis Indiana, 46202, United States More Info
Hristos Kaimakliotis, MD
Principal Investigator
Washington University
Saint Louis Missouri, 63130, United States More Info
Eric Kim, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

500

Study ID:

NCT05982561

Recruitment Status:

Recruiting

Sponsor:


Early is Good Inc.

How clear is this clinincal trial information?

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