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NCT Number: NCT06805630

Urine Methylation Markers in UTUC

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.

Recruiting

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Key information

Conditions

Upper Tract Urothelial Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Alireza Ghoreifinejadian, M.D.

CONTACT

[email protected]

919-684-8111

Alireza Ghoreifinejadian, M.D.

SUB_INVESTIGATOR

Michael Abern, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >=18 years
  • Primary UTUC

Exclusion criteria

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

Treatment and study plan

Bladder CARE™

Diagnostic Test

Urine methylation biomarker test

Primary outcomes

  1. Methylation level of urothelial-specific biomarker TRNA-Cys

    Time frame: Baseline, 3 months, 6 months

  2. Methylation level of urothelial-specific biomarker SIM2

    Time frame: Baseline, 3 months, 6 months

  3. Methylation level of urothelial-specific biomarker NKX1-1

    Time frame: Baseline, 3 months, 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Alireza Ghoreifinejadian, M.D.

CONTACT

[email protected]

919-684-8111

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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