Recruiting

Urine Tumor DNA

Sponsor:

Lahey Clinic

Code:

NCT07187063

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

UroAmp Test (Convergent Genomics, Inc.)

Study Details

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.

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC)

Study ID

NCT07187063

Start date

Jan 1, 2025

Status verified date

Sep, 2025

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: De-Intensified Arm

Less-frequent cystoscopy surveillance

no intervention: Standard Surveillance Arm

Regular follow-ups and standard care

Interventions

UroAmp Test (Convergent Genomics, Inc.)

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 outcome measure

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

Central Contacts and Locations

Central contacts

Linda Topjian

7817448420Linda.M.Topjian@lahey.org

Colette Osborne

Colette.A.Osborne@lahey.org

Locations

Lahey Hospital and Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Linda Topjian

7817448711linda.m.topjian@lahey.org

More Information

Sponsor

Lahey Clinic

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lahey Clinic on 2025-09-22.