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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bladder CARE™ | Diagnostic Test | Urine methylation biomarker test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alireza Ghoreifinejadian, M.D. | Contact | 919-684-8111 | alireza.ghoreifi@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Abern, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
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