Urine Methylation Markers in UTUC

NCT ID: NCT06805630

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-07

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Upper Tract Urothelial Cancer

Keywords

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UTUC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with primary UTUC (upper tract urothelial carcinoma)

Urine DNA samples will be quantified using Bladder CARE™ at baseline, 3 months, and 6 months.

Group Type OTHER

Bladder CARE™

Intervention Type DIAGNOSTIC_TEST

Urine methylation biomarker test

Interventions

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Bladder CARE™

Urine methylation biomarker test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* \>=18 years
* Primary UTUC

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Abern, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alireza Ghoreifinejadian, M.D.

Role: CONTACT

Phone: 919-684-8111

Email: [email protected]

Facility Contacts

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Alireza Ghoreifinejadian, M.D.

Role: primary

Other Identifiers

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Pro00116347

Identifier Type: -

Identifier Source: org_study_id