Urine DNA Test for Urinary Tract Cancer in Adults With Blood in Urine
Checks a urine DNA test for urothelial cancer in adults with blood in urine.
Plain-language title generated from the registry record
Registry title: Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT06469229, who can take part
Where in China
- Changhai HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Changhai Hospital
- Trial code
- NCT06469229
- Record updated
- 5 July 2024
- Original description
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.Read full original descriptionShow less
Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria: a Prospective, Multicenter Cohort Study
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.
Inclusion: 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: Patients who did not undergo surgical treatment for various reasons; Patients currently undergoing intravesical or systemic chemotherapy, radiotherapy, immunotherapy, or targeted therapy; With history of any malignancies (including UC); Severe urinary tract infection leading to sepsis; Severe liver or kidney failure or other conditions deemed unsuitable for the study; Patients with indwelling catheters, nephrostomy, or cystostomy; Samples with insufficient DNA content or other quality control failures; Incomplete clinical or pathological data.