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Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria

NCT06469229 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2024-07-05

No results posted yet for this study

Summary

Background 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.

Objectives To evaluate the sensitivity and specificity of urine DNA methylation testing for detecting UC in patients with hematuria, using standard clinical and pathological diagnoses as the gold standard. This study also aim to investigate the association between preoperative urine DNA methylation status and prognosis in UC patients.

For non-UC patients: Follow up for one year to assess the risk of UC development based on preoperative urine DNA methylation status.

Sample Size Calculation Expected sensitivity: 86% Expected specificity: 90% Significance level (Alpha): 0.05 Total participants needed: 1053 (adjusted for 5% dropout rate, 1109 participants will be recruited).

Study Procedure Enrollment and Sample Collection: Screen patients, obtain consent, collect urine samples.

Blinding and Testing: Blinded sample processing and DNA methylation testing. Unblinding and Analysis: Statistical analysis of sensitivity and specificity. Reporting: Compilation and consolidation of clinical trial reports.

Urine DNA methylation testing is expected to demonstrate high sensitivity and specificity for diagnosing urothelial carcinoma (UC) in patients with hematuria. This non-invasive diagnostic method promises to deliver valuable information, potentially leading to improved patient outcomes.

Conditions

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • First Hospital of China Medical University

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Changhai Hospital

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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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 NCT06469229 on ClinicalTrials.gov