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Clinical Trials/NCT07187063
NCT07187063RecruitingNot Applicable

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

Lahey Clinic2 sites in 1 country56 target enrollmentStarted: January 1, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
56
Locations
2
Primary Endpoint
Number of cystoscopies
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Number of cystoscopies

Time Frame: From enrollment to 24 months

The rate of cystoscopies (cystoscopies per month), compared between the De-intensified and the standard surveillance arms, is the primary outcome measure.

Secondary Outcomes

  • Event-free survival(From enrollment to 24 months)
  • Recurrence-free survival(From enrollment to 24 months)
  • Patient-reported outcomes(From enrollment to 24 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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