Trials / Active Not Recruiting
Active Not RecruitingNCT06842563
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 900 (estimated)
- Sponsor
- Singlera Genomics Inc. · Industry
- Sex
- All
- Age
- 18 Days
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2025-02-25
- Primary completion
- 2025-11-20
- Completion
- 2025-12-20
- First posted
- 2025-02-24
- Last updated
- 2025-07-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06842563. Inclusion in this directory is not an endorsement.