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

Inclusion Criteria3

  • AUA high-risk bladder cancer1
  • Received induction BCG or gemcitabine/docetaxel
  • Negative initial post-induction therapy assessment (negative cytology and cystoscopy +/- biopsy)

Exclusion Criteria4

  • High-risk NMIBC within 3 years
  • Prior induction intravesical therapy
  • Variant histology
  • Concurrent upper tract disease

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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