NCT06912672Not yet recruiting
Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma
Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma in Patients With Hematuria: A Prospective, Multi-center Cohort Study
Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. To evaluate the sensitivity and specificity of urine DNA methylation testing for detecting UC, using standard clinical and pathological diagnoses as the gold standard.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 2 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 May 2026
- Lead sponsor
- Shanghai Epiprobe Biotechnology Co., Ltd.
- Diseases
- Bladder cancer
- NCT number
- NCT06912672
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 1 May 2025 to the primary completion date, 1 May 2026
- No sites listed in no 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 currently undergoing intravesical or systemic chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
Other illness
- With history of any malignancies (including Urothelial carcinoma).
- 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 90 years, with gross or microscopic hematuria.
- Able to provide enough urine for testing before surgery.
- Consent to participate in the study and sign the informed consent form.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.