NCT06469229Not yet recruiting
Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria
Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria: a Prospective, Multicenter Cohort Study
Source: ClinicalTrials.gov · Last updated 5 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 17 Jun 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Changhai Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT06469229
What you commit to
- Study type: Observational
- Planned participants: 1200
- From 1 Jul 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who did not undergo surgical treatment for various reasons.
- Patients currently undergoing intravesical or systemic chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
Other illness
- 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.
Other
- Patients with indwelling catheters, nephrostomy, or cystostomy.
- Samples with insufficient DNA content or other quality control failures.
- Incomplete clinical or pathological data.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.