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

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.

Sex

All

Minimum age

18 Years

Maximum age

99 Years

Inclusion Criteria:

* Aged between 18 and 99 years, with gross or microscopic hematuria (RBC ≥ 3 /HPF or RBC \> 18 /μL for men, \> 33 /μL for women).
* Able to provide 50ml urine for testing before surgery.
* Consent to participate in the study and sign the informed consent form.

Exclusion Criteria:

* With history of any malignancies (including UC).
* Severe urinary tract infection leading to sepsis.
* Patients with indwelling catheters, nephrostomy, or cystostomy.
* Severe liver or kidney failure or other conditions deemed unsuitable for the study.
* Patients who did not undergo surgical treatment for various reasons.
* Samples with insufficient DNA content or other quality control failures.
* Incomplete clinical or pathological data.
* Patients currently undergoing intravesical or systemic chemotherapy, radiotherapy, immunotherapy, or targeted therapy.