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RecruitingInterventional

Urine-based Methylation Markers in the Diagnosis and Surveillance of Upper Tract Urothelial Carcinoma

NCT ID: NCT06805630Sponsor: Duke UniversityLast updated: 2026-06-01

Summary

This is a research study to measure DNA markers in the urine of patients with upper tract urothelial cancer (UTUC) before surgery and during follow-up visits. Identifying these DNA markers could improve diagnosis before surgery, help assess risk, and predict early recurrence of the cancer. Urine samples will be de-identified and sent to Pangea Laboratory LLC for analysis. The results of this test will be compared to the traditional tests in upper tract urothelial cancer, such as cells in the urine and tissue biopsy.

Arms & interventions

  • Diagnostic TestBladder CARE™

    Urine methylation biomarker test

Outcome measures

Primary

  • Methylation level of urothelial-specific biomarker TRNA-Cys

    Time frame: Baseline, 3 months, 6 months

  • Methylation level of urothelial-specific biomarker SIM2

    Time frame: Baseline, 3 months, 6 months

  • Methylation level of urothelial-specific biomarker NKX1-1

    Time frame: Baseline, 3 months, 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * \>=18 years * Primary UTUC Exclusion Criteria: * Patients who do not understand and/or are unwilling to sign a written informed consent

Study locations (1)

Duke University

Durham, North Carolina, 27710

Recruiting
Alireza Ghoreifinejadian, M.D. · Contact
919-684-8111alireza.ghoreifi@duke.edu
Michael Abern, M.D. · Principal Investigator
Alireza Ghoreifinejadian, M.D. · Sub Investigator
Urine Methylation Markers in UTUC | Cancerify