Urine Methylation Markers in UTUC

Last updated: November 10, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urothelial Carcinoma

Treatment

Bladder CARE™

Femto Human DNA Quantification Kit

Clinical Study ID

NCT06805630
Pro00116347
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • >=18 years

  • Primary UTUC

Exclusion

Exclusion Criteria:

  • Patients who do not understand and/or are unwilling to sign a written informedconsent

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Bladder CARE™
Phase:
Study Start date:
May 07, 2025
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Duke University

    Durham 4464368, North Carolina 4482348 27710
    United States

    Active - Recruiting

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