Status:
NOT_YET_RECRUITING
Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma
Lead Sponsor:
Shanghai Epiprobe Biotechnology Co., Ltd.
Collaborating Sponsors:
Changhai Hospital
RenJi Hospital
Conditions:
Urothelial Carcinoma
Eligibility:
All Genders
18-90 years
Brief Summary
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 methylati...
Detailed Description
Urothelial carcinoma (UC) is the most common malignancy of the urinary system, and early detection and diagnosis are crucial for patient prognosis. Hematuria is a significant clinical manifestation of...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- With history of any malignancies (including Urothelial carcinoma).
- 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.
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06912672
Start Date
May 1 2025
End Date
December 31 2026
Last Update
April 8 2025
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