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Recruiting NCT07187063

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

No phase Interventional Non-muscle Invasive Bladder Cancer (NMIBC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UroAmp Test (Convergent Genomics, Inc.).
Who it may be relevant to
Registry conditions: Non-muscle Invasive Bladder Cancer (NMIBC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test 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 measures

  • Number of cystoscopies [Time frame: From enrollment to 24 months]
Secondary outcome measures (3)
  • Event-free survival [Time frame: From enrollment to 24 months]
  • Recurrence-free survival [Time frame: From enrollment to 24 months]
  • Patient-reported outcomes [Time frame: From enrollment to 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Lahey Hospital and Medical Center — Burlington

Publications

  • 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
  • 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 PMID 37439796
  • 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 36233691

Identifiers

NCT: NCT07187063 · 20233622

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗