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NCT Number: NCT07187063

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

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.

Recruiting

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Key information

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC) Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location status: Recruiting

Location contact

Linda Topjian

CONTACT

[email protected]

7817448711

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Event-free survival

    Time frame: From enrollment to 24 months

    An event is defined as: high-grade recurrence, progression to muscle invasive disease, or metastatic disease

  2. Recurrence-free survival

    Time frame: 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

  3. Patient-reported outcomes

    Time frame: 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

Other outcomes

  1. Interim Analysis

    Time frame: 3 months

    After 50% enrollment, the rate of conversion from low-risk on the utDNA test to high risk will be evaluated at 3 months. If this rate exceeds 50%, the study will be terminated for futility.

Study contacts

Contact information is provided by the study sponsor or research team.

Colette Osborne

CONTACT

[email protected]

Linda Topjian

CONTACT

[email protected]

7817448420

Sponsors and collaborators

Lead sponsor

Lahey Clinic

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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