Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria
NCT Number: NCT06469229
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hematuria|Urothelial Carcinoma|Bladder Cancer|Ureter Cancer|Renal Pelvis Cancer
Sponsor: Changhai Hospital
Collaborators: RenJi Hospital|First Hospital of China Medical University|Tongji Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2027-12-31
Locations: Changhai Hospital, Shanghai, Shanghai, China

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.

Primary Outcome Measures: Diagnostic performance of DNA methylation test in patients with hematuria, Evaluate the diagnostic performance of DNA methylation biomarkers by calculating the sensitivity, specificity., 2 weeks
Secondary Outcome Measures: Other diagnostic performance of DNA methylation test in patients with hematuria, Calculate the Positive predictive value, negative predictive value，Diagnostic accuracy and the AUROC value of DNA methylation biomarkers., 2 weeks|Comparing the diagnostic performance of of urine DNA methylation and urine cytology, Comparing the sensitivity and specificity of urine DNA methylation and urine cytology for the diagnosis of UC in patients with hematuria., 2 weeks|The diagnosis effectiveness of urine DNA methylation test in different types of pathological characteristics of UC, Calculate the detection rate of urine DNA methylation test at different tumor grades, invasion depth, tumor size, and tumor number of UC patients, 2 weeks|UC patients follow-up, Evaluate the relationship between preoperative urine DNA methylation levels and postoperative progression-free survival in UC patients., 2 year|Non-UC patients follow-up, Evaluate the relationship between preoperative urine DNA methylation status and the risk of developing urothelial carcinoma within one year in patients diagnosed as non-UC., 2 year