Urine Methylation Markers in UTUC

Not Applicable

Recruiting

• Conditions: Upper Tract Urothelial Cancer

• Registration Number: NCT06805630
• Lead Sponsor: Duke University

Brief 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 Zymo/Pangea Research Corporation 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Status Verified: 2025-02
• Study First Posted: 2025-02-03
• Study Start: 2025-05-07
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• >=18 years
• Primary UTUC

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Methylation level of urothelial-specific biomarker TRNA-Cys	Baseline, 3 months, 6 months
Methylation level of urothelial-specific biomarker SIM2	Baseline, 3 months, 6 months
Methylation level of urothelial-specific biomarker NKX1-1	Baseline, 3 months, 6 months

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States