MedTrace Logo

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

NCT06912672 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-04-08

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Changhai Hospital

    collaborator OTHER

  • RenJi Hospital

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • First Hospital of China Medical University

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Shanghai Epiprobe Biotechnology Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-05-01
Completion
2026-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06912672 on ClinicalTrials.gov