NCT06805630

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
May 2025Jun 2026

First Submitted

Initial submission to the registry

January 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 7, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

November 12, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

January 28, 2025

Last Update Submit

November 10, 2025

Conditions

Upper Tract Urothelial Cancer

Keywords

UTUC

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Patients with primary UTUC (upper tract urothelial carcinoma)

OTHER

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

Diagnostic Test: Bladder CARE™

Interventions

Bladder CARE™DIAGNOSTIC_TEST

Urine methylation biomarker test

Patients with primary UTUC (upper tract urothelial carcinoma)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>=18 years
  • Primary UTUC

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Study Officials

  • Michael Abern, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alireza Ghoreifinejadian, M.D.

CONTACT

919-684-8111alireza.ghoreifi@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 3, 2025

Study Start

May 7, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

November 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)