Measuring DNA markers in urine for upper tract urothelial cancer
Urine-based Methylation Markers in the Diagnosis and Surveillance of Upper Tract Urothelial Carcinoma
This study is testing if measuring DNA markers in urine can help doctors better diagnose and monitor patients with upper tract urothelial cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06805630 on ClinicalTrials.gov |
What this trial studies
This study aims to measure DNA markers in the urine of patients diagnosed with upper tract urothelial cancer (UTUC) both before surgery and during follow-up visits. By identifying these DNA markers, the study seeks to enhance diagnostic accuracy, assess patient risk, and predict early recurrence of the cancer. Urine samples will be collected, de-identified, and analyzed by Zymo/Pangea Research Corporation, with results compared to traditional diagnostic methods such as urine cytology and tissue biopsy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with primary upper tract urothelial cancer.
Not a fit: Patients who are unable to understand or unwilling to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved early diagnosis and monitoring of upper tract urothelial cancer, potentially enhancing patient outcomes.
How similar studies have performed: Other studies have explored the use of urine biomarkers in cancer detection, showing promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>=18 years * Primary UTUC Exclusion Criteria: * Patients who do not understand and/or are unwilling to sign a written informed consent
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Michael Abern, MD — Duke University
- Study coordinator: Alireza Ghoreifinejadian, M.D.
- Email: alireza.ghoreifi@duke.edu
- Phone: 919-684-8111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.