Back to Clinical Trials

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

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

INTRODUCTION

  • Org Study ID: 20233622
  • Secondary ID: N/A
  • NCT ID: NCT07187063
  • 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.

  • Overall Status
    Recruiting
  • Start Date
    January 1, 2025
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of cystoscopies

Primary Outcome 1 - Timeframe: From enrollment to 24 months

CONDITION

  • Non-muscle Invasive Bladder Cancer (NMIBC)

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Matthew B Clements, MD, MS

Role: Principal Investigator

Affiliation: Lahey Hospital & Medical Center

Overall Contact

Name: Linda Topjian, Colette Osborne

Phone: 7817448420

Email: [email protected], [email protected]

LOCATION

Facility Status Contact
Facility: Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
United States
Status: Recruiting Contact: Contact
Linda Topjian
7817448711
[email protected]