Clinical trial NCT06842563: Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
Official title: A Multicenter Clinical Trial to Evaluate the Clinical Performance and Accuracy of the Human DAB2IP, CHFR, and GRASP Gene Methylation Kit (PCR-fluorescence Probe) in Patients with Suspected Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Hepatocellular carcinoma
HBV or HCV infection
Nonalcoholic steatohepatitis
Liver cirrhosis
Benign hepatopathy
Family history of liver cancer
Lead sponsor: Singlera Genomics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Zhongshan Hospital
name: The Affiliated Hospital of Xuzhou Medical University
First posted: 2025-02-24
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: The purpose of this clinical trial was to systematically study the clinical performance and accuracy of the human DAB2IP, CHFR and GRASP gene methylation combined test kit (PCR-fluorescent probe method) produced by Jiangsu Kunyuan Biotechnology Co., LTD. The test reagent was compared with the clinical reference standard (pathological diagnosis and/or imaging diagnosis) to verify the clinical performance of the product. At the same time, for each gene that can be detected by the assessment reagent, the digital PCR method is used as a comparison method to verify the accuracy of the assessment reagent detection. The validity of the assessment reagent can meet the requirements of its intended use from the above two aspects, and provide sufficient clinical evaluation data for the registration and application of the product in China.


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. Subjects who meet one of the following conditions:

   (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.;
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.

Primary outcomes:
measure: Study on the clinical performance of human DAB2IP, CHFR and GRASP gene methylation detection kit (PCR-fluorescent probe method)
timeFrame: From enrollment to the end of detection at 16 week
Secondary outcomes:
measure: Accuracy of human DAB2IP, CHFR and GRASP gene methylation detection kit (PCR-fluorescent probe method)
timeFrame: From enrollment to the end of detection at 16 week
Other outcomes:
Locations:
Study officials:
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