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

NCT ID: NCT07187063Sponsor: Lahey ClinicLast updated: 2025-09-22

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.

Arms & interventions

  • Diagnostic TestUroAmp 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.

Outcome measures

Primary

  • 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.

    Time frame: From enrollment to 24 months

Secondary

  • 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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805

Recruiting
Linda Topjian · Contact
7817448711linda.m.topjian@lahey.org

References

  • 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 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.(PubMed)
  • 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.(PubMed)
Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer | Cancerify