Clinical Trial

Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma

Study acronym: UMT-UC
Not Yet Recruiting
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Record status
This record was last updated April 8, 2025 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
Urothelial carcinoma (UC) is the most common malignancy of the urinary system. Hematuria is a significant clinical manifestation of UC, often diagnosed through invasive procedures. Urine DNA methylation testing is a promising non-invasive method for early UC detection. To evaluate the sensitivity and specificity of urine DNA methylation testing for detecting UC, using standard clinical and pathological diagnoses as the gold standard.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-03.
Trial Details
NCT Number NCT06912672
Lead Sponsor Shanghai Epiprobe Biotechnology Co., Ltd.
Collaborators: Changhai Hospital, RenJi Hospital, Tongji Hospital, First Hospital of China Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions Urothelial Carcinoma
Enrollment 1,500 participants
Start Date 2025-05-01
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-08