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

INTRODUCTION

  • Org Study ID: Pro00116347
  • Secondary ID: N/A
  • NCT ID: NCT06805630
  • 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.

  • Overall Status
    Recruiting
  • Start Date
    May 7, 2025
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Methylation level of urothelial-specific biomarker TRNA-Cys

Primary Outcome 1 - Timeframe: Baseline

Primary Outcome 2 - Measure: Methylation level of urothelial-specific biomarker SIM2

Primary Outcome 2 - Timeframe: 3 months

Primary Outcome 3 - Measure: Methylation level of urothelial-specific biomarker NKX1-1

Primary Outcome 3 - Timeframe: 6 months

CONDITION

  • Upper Tract Urothelial Cancer

ELIGIBILITY

Inclusion Criteria:
* >=18 years

- * Primary UTUC
Exclusion Criteria:
* Patients who do not understand and/or are unwilling to sign a written informed consent

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Michael Abern, MD

Role: Principal Investigator

Affiliation: Duke University

Overall Contact

Name: Alireza Ghoreifinejadian, M.D.

Phone: 919-684-8111

Email: [email protected]

LOCATION

Facility Status Contact
Facility: Duke University
Durham, North Carolina 27710
United States
Status: Recruiting Contact: Contact
Alireza Ghoreifinejadian, M.D.
919-684-8111
[email protected]

Principal Investigator
Michael Abern, M.D.

Sub-Investigator
Alireza Ghoreifinejadian, M.D.