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

Not Applicable

Recruiting

• Conditions: Non-muscle Invasive Bladder Cancer (NMIBC)

• Registration Number: NCT07187063
• Lead Sponsor: Lahey Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Study First Submitted: 2025-08-15
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2029-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of cystoscopies	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 Outcome Measures

Name	Time	Method
Event-free survival	From enrollment to 24 months	An event is defined as: high-grade recurrence, progression to muscle invasive disease, or metastatic disease
Recurrence-free survival	From enrollment to 24 months	We will compare the rate of any recurrences (including low-grade) between the De-intensified and the standard surveillance groups
Patient-reported outcomes	From enrollment to 24 months	The National Comprehensive Cancer Network Distress thermometer and the European Organisation For Research And Treatment Of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Non-Muscle Invasive Bladder Cancer (NMIBC-24) Module will be collected and compared between study arms

Trial Locations

Locations (1)

Lahey Hospital and Medical Center; 🇺🇸 Burlington, Massachusetts, United States