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

Part of paid clinical trials in Burlington, Massachusetts.

Sponsor
Lahey Clinic
Study ID
NCT07187063
Status
Recruiting
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Conditions

  • Non-muscle Invasive Bladder Cancer (NMIBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UroAmp Test (Convergent Genomics, Inc.) — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
Sep 2025
Primary completion
Jan 1, 2029
Completion
Jan 1, 2029

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: De-Intensified Arm
    Less-frequent cystoscopy surveillance
  • No Intervention: Standard Surveillance Arm
    Regular follow-ups and standard care

Primary Outcome Measure

Number of cystoscopies [ Time Frame: From enrollment to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lahey Hospital and Medical CenterBurlingtonMassachusetts01805
Linda Topjian
[email protected]
7817448711

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By research site
Lahey Hospital and Medical Center· Burlington, MA

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