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

Not yet recruitingOBSERVATIONAL
Enrollment

1,500

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

May 1, 2026

Study Completion Date

December 31, 2026

Conditions
Urothelial Carcinoma
Interventions
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.

All Listed Sponsors
collaborator

Changhai Hospital

OTHER

collaborator

RenJi Hospital

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

First Hospital of China Medical University

OTHER

collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

lead

Shanghai Epiprobe Biotechnology Co., Ltd.

INDUSTRY