RecruitingNot ApplicableNCT07187063

Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer


Sponsor

Lahey Clinic

Enrollment

56 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether monitoring urine for tumor DNA (genetic material shed by cancer cells) can help reduce the need for frequent invasive surveillance procedures in people with high-risk non-muscle-invasive bladder cancer who have responded well to initial treatment. **You may be eligible if...** - You have high-risk non-muscle-invasive bladder cancer (confined to the bladder lining) - You have completed an induction course of BCG or gemcitabine/docetaxel treatment - Your post-treatment assessment (cystoscopy and urine tests) came back negative for cancer **You may NOT be eligible if...** - You have had high-risk bladder cancer within the past 3 years - You have had prior bladder instillation therapy - Your cancer is of an unusual (variant) cell type - You have concurrent cancer in the upper urinary tract (kidney or ureter) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTUroAmp Test (Convergent Genomics, Inc.)

Non-invasive genomic urine test that can reliably detect, monitor, and predict the risk of urothelial cancer or its recurrence, potentially before signs and symptoms develop or become detectable by historical standards of care.


Locations(1)

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

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NCT07187063


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