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

NCT06842563 | Active Not Recruiting

• 1 other identifier: SGI-PCR-02
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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)

Keywords

Hepatocellular carcinoma; HBV or HCV infection; Nonalcoholic steatohepatitis; Liver cirrhosis; Benign hepatopathy; Family history of liver cancer

Outcome Measures

Primary Outcomes (1)

• Study on the clinical performance of human DAB2IP, CHFR and GRASP gene methylation detection kit (PCR-fluorescent probe method)

  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

  From enrollment to the end of detection at 16 week

Secondary Outcomes (1)

• 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

Study Arms (2)

Case group

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

control group

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

Eligibility Criteria

• Age: 18 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

(i) Initial treatment subjects with symptoms and/or signs suspected of hepatocellular carcinoma as determined by the clinician; People with HBV or HCV infection, excessive alcohol consumption, non-alcoholic steatohepatitis, cirrhosis of the liver from other causes (LC), benign hepatopathy (BHL), and a family history of liver cancer; iii Subjects with other tumors, including but not limited to esophageal, stomach, colorectal, pancreatic, lung, breast, prostate, etc

You may qualify if:

• Age 18 years or older, gender unlimited;
• Subjects for whom sufficient blood samples can be obtained (whole blood volume not less than 10 mL);
• 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.
• Voluntarily participate in the experiment and sign the informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Singlera Genomics Inc.: lead
• Shanghai Zhongshan Hospital: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University in Shanghai

Shanghai, Shanghai Municipality, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma sample DNA sample

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis B; Hepatitis C; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Flaviviridae Infections; RNA Virus Infections; Fatty Liver; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 24, 2025
• Study Start: February 25, 2025
• Primary Completion: November 20, 2025
• Study Completion: December 20, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)