Clinical trial · Interventional
Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
NCT07187063CI-TRIAL-00095606recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-muscle Invasive Bladder Cancer (NMIBC) | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UroAmp Test (Convergent Genomics, Inc.) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- De-Intensified Arm
- description
- Less-frequent cystoscopy surveillance
- interventionNames
- Diagnostic Test: UroAmp Test (Convergent Genomics, Inc.)
- type
- NO_INTERVENTION
- label
- Standard Surveillance Arm
- description
- Regular follow-ups and standard care
Primary outcomes (1)
- measure
- Number of cystoscopies
- timeFrame
- From enrollment to 24 months
- description
- The rate of cystoscopies (cystoscopies per month), compared between the De-intensified and the standard surveillance arms, is the primary outcome measure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDClinical Trials in Progress: Bladder Cancer: Monday, April 28, 9-11 am. Journal of Urology. https://doi.org/10.1097/01.JU.0001110440.53375.7d
- BACKGROUNDSalari 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 37439796
- BACKGROUNDBicocca 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