Urine Methylation Markers in UTUC

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06805630
Status
Recruiting
Apply to this trial

Conditions

  • Upper Tract Urothelial Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bladder CARE™ — DIAGNOSTIC_TEST
    Urine methylation biomarker test

Study Details

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.

Key Dates

Start date
May 7, 2025
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Patients with primary UTUC (upper tract urothelial carcinoma)
    Urine DNA samples will be quantified using Bladder CARE™ at baseline, 3 months, and 6 months.

Primary Outcome Measure

Methylation level of urothelial-specific biomarker TRNA-Cys [ Time Frame: Baseline, 3 months, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710
Alireza Ghoreifinejadian, M.D.
[email protected]
919-684-8111
Michael Abern, M.D. (PRINCIPAL_INVESTIGATOR)
Alireza Ghoreifinejadian, M.D. (SUB_INVESTIGATOR)

Find similar trials in Durham, NC

By research site
Duke University· Durham, NC

Related Studies