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Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
Sponsor: Singlera Genomics Inc.
Summary
This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection. The test results are compared against clinical reference standards, including pathological and/or imaging diagnoses, to assess the product's diagnostic performance. Additionally, for each gene detectable by the HepaAiQ assay, digital PCR is used as a comparator to validate analytical accuracy. The dual approach-clinical and analytical validation-supports the intended use of the test and provides sufficient clinical evidence for its registration and regulatory submission in China.
Official title: A Multicenter Clinical Trial to Evaluate the Clinical Performance and Accuracy of the Human DAB2IP, CHFR, and GRASP Gene Methylation Kit (PCR-fluorescence Probe) in Patients With Suspected Hepatocellular Carcinoma
Key Details
Gender
All
Age Range
18 Days - Any
Study Type
OBSERVATIONAL
Enrollment
900
Start Date
2025-02-25
Completion Date
2025-12-20
Last Updated
2025-07-09
Healthy Volunteers
No
Conditions
Locations (1)
Zhongshan Hospital Affiliated to Fudan University in Shanghai
Shanghai, Shanghai Municipality, China