Not Yet RecruitingNot Applicable

Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma

1,500 participantsStarted 2025-05-01

Plain-language 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 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Diagnostic performance of DNA methylation test for urothelial carcinoma

Timeframe: 2 weeks

Trial details

NCT IDNCT06912672

SponsorShanghai Epiprobe Biotechnology Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-05-01

Contact for this trial

Yaping Dong

86-18046043049 dongyaping@epiprobe.com

View on ClinicalTrials.gov More Urothelial Carcinoma trials