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

N/AActive Not RecruitingNCT06842563

Singlera Genomics Inc.900 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

900

Conditions

Hepatocellular Carcinoma (HCC)

Eligibility

Sex: ALLMin age: 18 Days

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: From enrollment to the end of detection at 16 week

Secondary Outcomes

Accuracy of human DAB2IP, CHFR and GRASP gene methylation detection kit (PCR-fluorescent probe method)

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