Urine Methylation Markers in UTUC

Urine-based Methylation Markers in the Diagnosis and Surveillance of Upper Tract Urothelial Carcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06805630

Enrollment

Registered

2025-02-03

Start date

2025-05-07

Completion date

2026-12-30

Last updated

2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Tract Urothelial Cancer

Keywords

UTUC

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 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.

Interventions

DIAGNOSTIC_TESTBladder CARE™

Urine methylation biomarker test

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* \>=18 years * Primary UTUC

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMichael Abern, MD

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026