Urine Methylation Markers in UTUC

N/AActive Not RecruitingNCT06805630

Duke University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Upper Tract Urothelial Cancer

Interventions

Bladder CARE™DIAGNOSTIC_TEST

Urine methylation biomarker test

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \>=18 years * Primary UTUC Exclusion Criteria: * Patients who do not understand and/or are unwilling to sign a written informed consent

Locations (1)

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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