Hepatocellular Carcinoma (HCC)
Conditions
Keywords
Hepatocellular carcinoma, HBV or HCV infection, Nonalcoholic steatohepatitis, Liver cirrhosis, Benign hepatopathy, Family history of liver cancer
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.
Interventions
None listed
Sponsors
Shanghai Zhongshan Hospital
The Affiliated Hospital of Xuzhou Medical University
Singlera Genomics Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Days to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed