NCT07187063

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
33mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Jan 2025Jan 2029

Study Start

First participant enrolled

January 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

August 15, 2025

Last Update Submit

September 18, 2025

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC)

Outcome Measures

Primary Outcomes (1)

  • Number of cystoscopies

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

    From enrollment to 24 months

Secondary Outcomes (3)

  • Event-free survival

    From enrollment to 24 months

  • Recurrence-free survival

    From enrollment to 24 months

  • Patient-reported outcomes

    From enrollment to 24 months

Other Outcomes (1)

  • Interim Analysis

    3 months

Study Arms (2)

De-Intensified Arm

EXPERIMENTAL

Less-frequent cystoscopy surveillance

Diagnostic Test: UroAmp Test (Convergent Genomics, Inc.)

Standard Surveillance Arm

NO INTERVENTION

Regular follow-ups and standard care

Interventions

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.

De-Intensified Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

RECRUITING

Related Publications (3)

  • Clinical Trials in Progress: Bladder Cancer: Monday, April 28, 9-11 am. Journal of Urology. https://doi.org/10.1097/01.JU.0001110440.53375.7d

    BACKGROUND

  • Salari K, Sundi D, Lee JJ, Wu S, Wu CL, DiFiore G, Yan QR, Pienkny A, Lee CK, Oberlin D, Barme G, Piser J, Kahn R, Collins E, Phillips KG, Caruso VM, Goudarzi M, Garcia-Ransom M, Lentz PS, Evans-Holm ME, MacBride AR, Fischer DS, Haddadzadeh IJ, Mazzarella BC, Gray JW, Koppie TM, Bicocca VT, Levin TG, Lotan Y, Feldman AS. Development and Multicenter Case-Control Validation of Urinary Comprehensive Genomic Profiling for Urothelial Carcinoma Diagnosis, Surveillance, and Risk-Prediction. Clin Cancer Res. 2023 Sep 15;29(18):3668-3680. doi: 10.1158/1078-0432.CCR-23-0570.

    PMID: 37439796BACKGROUND

  • Bicocca VT, Phillips KG, Fischer DS, Caruso VM, Goudarzi M, Garcia-Ransom M, Lentz PS, MacBride AR, Jensen BW, Mazzarella BC, Koppie T, Korkola JE, Gray JW, Levin TG. Urinary Comprehensive Genomic Profiling Correlates Urothelial Carcinoma Mutations with Clinical Risk and Efficacy of Intervention. J Clin Med. 2022 Sep 30;11(19):5827. doi: 10.3390/jcm11195827.

    PMID: 36233691BACKGROUND

Related Links

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrinary Bladder NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Matthew B Clements, MD, MS

    Lahey Hospital & Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Topjian

CONTACT

7817448420Linda.M.Topjian@lahey.org

Colette Osborne

CONTACT

Colette.A.Osborne@lahey.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2025

First Posted

September 22, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations

US(1)