Urine Methylation Markers in UTUC
ConditionUpper Tract Urothelial Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>=18 years
Primary UTUC
Disqualifiers
Patients who do not understand and/or are unwilling to sign a written informed consent
Trial design
Design model
Single group
Treatments tested in this trial
Bladder CARE™
Diagnostic testUrine methylation biomarker test
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Patients with primary UTUC (upper tract urothelial carcinoma)Other 1 intervention
Trial outcomes
Primary outcomes
1
Methylation level of urothelial-specific biomarker TRNA-Cys
Time frame
Baseline, 3 months, 6 months2
Methylation level of urothelial-specific biomarker SIM2
Time frame
Baseline, 3 months, 6 months3
Methylation level of urothelial-specific biomarker NKX1-1
Time frame
Baseline, 3 months, 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov