NCT06842563Active, not recruiting
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
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
Source: ClinicalTrials.gov · Last updated 9 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 900 (estimated)
- First submitted
- 13 Feb 2025
- Start date
- 25 Feb 2025
- Primary completion date
- 20 Nov 2025
- Lead sponsor
- Singlera Genomics Inc.
- NCT number
- NCT06842563
What you commit to
- Study type: Observational
- Planned participants: 900
- From 25 Feb 2025 to the primary completion date, 20 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Liver cancer subjects who have received previous treatment, such as radiotherapy and chemotherapy, surgery, etc.;
Other illness
- Subjects with other malignant tumors;
- Subjects with recurrent liver cancer confirmed or suspected by the investigator;
Other
- Subjects whose information is missing or untraceable;
- The researcher believes that the subjects should not be included in this study for other reasons.
Who the study is looking for
- 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.
Age in the registry: 18 days to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University in Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.