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NCT06842563

Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial

Sponsor: Singlera Genomics Inc.

View on ClinicalTrials.gov

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

Locations (1)

Zhongshan Hospital Affiliated to Fudan University in Shanghai

Shanghai, Shanghai Municipality, China