Hepatocellular Carcinoma (HCC)NCT06842563
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
An observational study of Hepatocellular Carcinoma (HCC), run by Singlera Genomics Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 days and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- Type of treatment
- Injection or infusion
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2025to 20 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Affiliated to Fudan University in Shanghai
Shanghai, Shanghai Municipality
About this study
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
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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular carcinoma, HBV or HCV infection, Nonalcoholic steatohepatitis, Liver cirrhosis, Benign hepatopathy, Family history of liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B, Hepatitis C, Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Hepatocellular carcinoma (including stage I-IV) for initial treatment | |
| control group | Hepatitis, cirrhosis, benign lesions of the liver and other tumors (esophageal, gastric, bile duct, bowel, breast, lung, pancreatic, prostate cancer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of detection at 16 week
Secondary outcomes (1)
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
Measured: From enrollment to the end of detection at 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start25 Feb 2025
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singlera Genomics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital, The Affiliated Hospital of Xuzhou Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842563
- Sponsor's protocol ID
- SGI-PCR-02
- Status last verified
- Jul 2025
- First submitted
- 13 Feb 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06842563
- Acronym / sponsor ID
- SGI-PCR-02
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular carcinoma, HBV or HCV infection, Nonalcoholic steatohepatitis, Liver cirrhosis, Benign hepatopathy, Family history of liver cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Singlera Genomics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital, The Affiliated Hospital of Xuzhou Medical University
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | –Hepatocellular carcinoma (including stage I-IV) for initial treatment |
| control group | – | –Hepatitis, cirrhosis, benign lesions of the liver and other tumors (esophageal, gastric, bile duct, bowel, breast, lung, pancreatic, prostate cancer) |
Who may qualify
- Ages
- 18 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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:
- Voluntarily participate in the experiment and sign the informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by Singlera Genomics Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.