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Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma
Sponsor: Shanghai Epiprobe Biotechnology Co., Ltd.
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.
Official title: Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma in Patients With Hematuria: A Prospective, Multi-center Cohort Study
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
OBSERVATIONAL
Enrollment
1500
Start Date
2025-05-01
Completion Date
2026-12-31
Last Updated
2025-04-08
Healthy Volunteers
No
Conditions
Interventions
Evaluate the diagnostic performance of EPIPROBE TAGMe DNA Methylation Detection Kit for Urothelial Cancer
The study aims to evaluate the diagnostic performance of the EPIPROBE TAGMe DNA Methylation Detection Kit for the detection of urothelial cancer. This assay utilizes targeted DNA methylation analysis to identify specific epigenetic alterations associated with urothelial malignancies. The performance of the kit will be assessed in terms of sensitivity, specificity, and overall diagnostic accuracy using clinical urine samples from a patient population with hematuria.