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

Active, not recruiting

• Conditions: Hepatocellular Carcinoma (HCC)

• Registration Number: NCT06842563
• Lead Sponsor: Singlera Genomics Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-18
• Study First Posted: 2025-02-24
• Study Start: 2025-02-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-09
• Primary Completion: 2025-11-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1. Age 18 years or older, gender unlimited;

2. Subjects for whom sufficient blood samples can be obtained (whole blood volume not less than 10 mL);

3. The performance of the blood-based, multi-gene methylation test is being evaluated in a diverse population including:

   (i) Treatment-naïve individuals presenting with signs and/or symptoms suggestive of hepatocellular carcinoma (HCC) as assessed by clinicians; (ii) Individuals at high risk for liver cancer, including those with HBV or HCV infection, excessive alcohol intake, non-alcoholic steatohepatitis (NASH), liver cirrhosis of various etiologies (LC), benign hepatic lesions (BHL), or a family history of liver cancer; (iii) Patients with other malignancies, including but not limited to esophageal, gastric, colorectal, pancreatic, lung, breast, and prostate cancers.

4. Voluntarily participate in the experiment and sign the informed consent.

Exclusion Criteria

1. Liver cancer subjects who have received previous treatment, such as radiotherapy and chemotherapy, surgery, etc.;
2. Subjects with other malignant tumors;
3. Subjects with recurrent liver cancer confirmed or suspected by the investigator;
4. Subjects whose information is missing or untraceable;
5. The researcher believes that the subjects should not be included in this study for other reasons.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study on the clinical performance of human DAB2IP, CHFR and GRASP gene methylation detection kit (PCR-fluorescent probe method)	From enrollment to the end of detection at 16 week	By comparing the test reagent with the clinical reference standard (pathological diagnosis and/or imaging diagnosis), the test results of the test reagent were compared with the clinical reference standard to verify the clinical performance of the product

Secondary Outcome Measures

Name	Time	Method
Accuracy of human DAB2IP, CHFR and GRASP gene methylation detection kit (PCR-fluorescent probe method)	From enrollment to the end of detection at 16 week	For each gene detected by the test reagent, the digital PCR method was used as a comparison method to verify the accuracy of the test reagent detection

Trial Locations

Locations (1)

Zhongshan Hospital Affiliated to Fudan University in Shanghai; 🇨🇳 Shanghai, Shanghai, China