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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Fatty Liver Fibrosis Flaviviridae Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis C Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital Affiliated to Fudan University in Shanghai

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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

Time frame: 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 outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Singlera Genomics Inc.

Industry

Collaborators

Shanghai Zhongshan Hospital
The Affiliated Hospital of Xuzhou Medical University

Registry information

Official study 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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 24, 2025
Registry last updated: Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting