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

NCT ID: NCT06842563

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2025-12-20

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.

Conditions

Hepatocellular Carcinoma (HCC)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case group

Hepatocellular carcinoma (including stage I-IV) for initial treatment

No interventions assigned to this group

control group

Hepatitis, cirrhosis, benign lesions of the liver and other tumors (esophageal, gastric, bile duct, bowel, breast, lung, pancreatic, prostate cancer)

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role: collaborator

Singlera Genomics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital Affiliated to Fudan University in Shanghai

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SGI-PCR-02

Identifier Type: -

Identifier Source: org_study_id