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Urine Methylation Markers in Upper Tract Urothelial Cancer

This study is looking at a new urine test called Bladder CARE™ to help diagnose and manage upper tract urothelial cancer (UTUC). Researchers want to see if measuring specific DNA markers (TRNA-Cys, SIM2, and NKX1-1) in your urine can improve how doctors diagnose UTUC before surgery, assess your risk, and predict if the cancer might come back early. You can join if you are at least 18 years old and have primary UTUC. The study aims to enroll 50 participants. The goal is to see if these urine markers are as good as or better than traditional tests like urine cell analysis and tissue biopsies.

Study design
This is an interventional study that plans to enroll 50 participants. It is not specified if it is randomized or blinded.
What's involved
You would provide urine samples at the start of the study, and then again at 3 months and 6 months. These samples will be sent for analysis.
Compensation
Not stated in the trial record.
Follow-up
Your methylation levels will be measured at baseline, 3 months, and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06805630

Urine Methylation Markers in UTUC

Active, Not Recruiting
NAAges 18+InterventionalDiagnostic
Duke University
~50 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Bladder CARE™

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Methylation level of urothelial-specific biomarker TRNA-Cys
Measured over Baseline, 3 months, 6 months
+2 more outcomes measured

Conditions

Upper Tract Urothelial Cancer

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Duke University

    Durham, North Carolinano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Michael Abern, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

\>=18 years
Primary UTUC

Exclusion

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

What this trial measures

  • Methylation level of urothelial-specific biomarker TRNA-CysBaseline, 3 months, 6 months
  • Methylation level of urothelial-specific biomarker SIM2Baseline, 3 months, 6 months
  • Methylation level of urothelial-specific biomarker NKX1-1Baseline, 3 months, 6 months