Actively Recruiting
Urine-based Methylation Markers in the Diagnosis and Surveillance of Upper Tract Urothelial Carcinoma
Led by Duke University · Updated on 2026-06-01
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study focuses on patients with upper tract urothelial cancer (UTUC). It aims to measure specific DNA markers in urine before surgery and during follow-up visits. The goal is to see if these markers can improve diagnosis, help assess risk, and predict early cancer recurrence compared to traditional tests like urine cell analysis and tissue biopsy. Participants will provide urine samples that are analyzed using the Bladder CARE™ methylation biomarker test at the start of the study, 3 months, and 6 months later. These urine DNA samples will be sent to a specialized laboratory for detailed analysis of specific urothelial biomarkers. During the study, participants will provide urine samples at the scheduled times for analysis. Researchers will measure methylation levels of urothelial-specific biomarkers TRNA-Cys, SIM2, and NKX1-1 at baseline, 3 months, and 6 months. The study tracks these results to compare with traditional diagnostic tests and monitor changes over time.
CONDITIONS
Brief Title
Urine Methylation Markers in UTUC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with primary upper tract urothelial cancer (UTUC)
You will not qualify if you...
- Unable to understand or unwilling to sign a written informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants provide urine samples to test for methylation biomarkers using the Bladder CARE™ test.
3 visits (baseline, 3 months, and 6 months)
Trial Site Locations
Total: 1 location
1
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
A
Alireza Ghoreifinejadian, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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