Urine Methylation Markers in UTUC

Duke University

Status: Enrolling

Conditions: Upper Tract Urothelial Cancer

Treatments: Diagnostic Test: Bladder CARE™

Study type: Interventional

Funder types: Other

Identifiers

NCT06805630

Pro00116347

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >=18 years
• Primary UTUC

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Patients with primary UTUC (upper tract urothelial carcinoma)

Other group

Description:

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

Treatment:

Diagnostic Test: Bladder CARE™