NCT06912672

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

Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma in Patients With Hematuria: A Prospective, Multi-center Cohort Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Shanghai Epiprobe Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Urothelial carcinoma (UC) is the most common malignancy of the urinary system, and early detection and diagnosis are crucial for patient prognosis. Hematuria is a significant clinical manifestation of UC, but its diagnosis often relies on invasive procedures and imaging, posing a substantial burden on patients. With the advancement of molecular biology techniques, urine DNA methylation testing has emerged as a non-invasive and highly sensitive method for early UC detection. This study aims to evaluate the performance of urine DNA methylation testing in detecting UC in patients with hematuria. All patients with hematuria will receive standard clinical diagnosis, including examinations, tests, surgeries, and pathological assessments to determine the presence of UC. These clinical diagnoses will serve as the gold standard to evaluate the sensitivity and specificity of urine DNA methylation testing in detecting UC in patients with hematuria. To ensure accuracy and reliability of the results, select a subset of samples with known test results for external methylation sequencing. Authorized researchers will unblind the samples, and the statistical team will analyze the results, calculating sensitivity, specificity, positive predictive value, and negative predictive value of the urine DNA methylation test.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-01
• Completion: 2026-12-31
• First posted: 2025-04-06
• Last updated: 2025-04-08