Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
NCT ID: NCT07187063
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
56 participants
INTERVENTIONAL
2025-01-01
2029-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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De-Intensified Arm
Less-frequent cystoscopy surveillance
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.
Standard Surveillance Arm
Regular follow-ups and standard care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Received induction BCG or gemcitabine/docetaxel
* Negative initial post-induction therapy assessment (negative cytology and cystoscopy +/- biopsy)
Exclusion Criteria
* Prior induction intravesical therapy
* Variant histology
* Concurrent upper tract disease
18 Years
ALL
No
Sponsors
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Lahey Clinic
OTHER
Responsible Party
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Principal Investigators
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Matthew B Clements, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Lahey Hospital & Medical Center
Locations
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Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Related Links
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Patient-oriented presentation on the study
Other Identifiers
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20233622
Identifier Type: -
Identifier Source: org_study_id
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