Primary Liver CancerNCT07466602
cfDNA Methylation for Liver Cancer Recurrence Detection
An observational study of Primary Liver Cancer, run by Wuhan Ammunition Life-tech Co., Ltd at 1 site in China.
Trial summary
Through follow-up testing of patients with primary liver cancer who underwent hepatectomy, liver transplantation, ablation therapy, or transarterial chemoembolization (TACE), a blinded comparative trial was conducted at each monitoring site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Liver Cancer
- What is being tested?
- plasma GNB4 and Riplet genes methylation detection
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2025to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study investigates patients with primary liver cancer, encompassing three types: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and mixed liver cancer.
Who may be able to join
- Primary liver cancer
Who cannot join
- Concurrent other malignant tumors;
- Ineligible for hepatectomy, liver transplantation, ablation, or TACE therapy;
- Negative methylation status prior to treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Zeyang Ding, MD, +86 13407156200, zyding@tjh.tjmu.edu.cn
Wanguang Zhang, MD
About this study
Official title: Clinical Study on the Combined Detection of Plasma GNB4 and Riplet Gene Methylation for Monitoring Primary Liver Cancer Recurrence
Through follow-up testing of patients with primary liver cancer who underwent hepatectomy, liver transplantation, ablation therapy, or transarterial chemoembolization (TACE), a blinded comparative trial was conducted at each monitoring site. This trial evaluated the combined methylation detection kit for GNB4 and Riplet genes (fluorescent PCR method) against the clinical reference standard (defined as the physician's comprehensive diagnosis based on clinical guidelines and other criteria). The study evaluated the clinical performance of the assay in diagnosing primary liver cancer recurrence and validated the clinical efficacy of methylation detection kits for monitoring recurrence after primary liver cancer treatment.
- Conditions
- Primary Liver Cancer
- Being tested
- plasma GNB4 and Riplet genes methylation detection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma GNB4 and Riplet genes methylation detectionDiagnostic test
Liver cancer patients undergo methylation testing at different follow-up time points after treatment
| Study group | Role | What they receive |
|---|---|---|
| Primary liver cancer patients | Not described Receives: Diagnostic Test: plasma GNB4 and Riplet genes methylation detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
Measured: Through study completion, an average of 1 year
specificity
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start2 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Ammunition Life-tech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466602
- Sponsor's protocol ID
- AD07-2
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Combined Detection of Plasma GNB4 and Riplet Gene Methylation for Monitoring Primary Liver Cancer Recurrence
- ClinicalTrials.gov ID
- NCT07466602
- Acronym / sponsor ID
- AD07-2
- Conditions
- Primary Liver Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wuhan Ammunition Life-tech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Mar 2026 (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.
Through follow-up testing of patients with primary liver cancer who underwent hepatectomy, liver transplantation, ablation therapy, or transarterial chemoembolization (TACE), a blinded comparative trial was conducted at each monitoring site. This trial evaluated the combined methylation detection kit for GNB4 and Riplet genes (fluorescent PCR method) against the clinical reference standard (defined as the physician's comprehensive diagnosis based on clinical guidelines and other criteria). The study evaluated the clinical performance of the assay in diagnosing primary liver cancer recurrence and validated the clinical efficacy of methylation detection kits for monitoring recurrence after primary liver cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary liver cancer patients | – | Diagnostic Test: plasma GNB4 and Riplet genes methylation detection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study investigates patients with primary liver cancer, encompassing three types: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and mixed liver cancer.
Key inclusion criteria (1 listed)
- Primary liver cancer
Key exclusion criteria (3 listed)
- Concurrent other malignant tumors;
- Ineligible for hepatectomy, liver transplantation, ablation, or TACE therapy;
- Negative methylation status prior to treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasma GNB4 and Riplet genes methylation detectionLiver cancer patients undergo methylation testing at different follow-up time points after treatment | Diagnostic test | Primary liver cancer patients |
Primary outcome
sensitivity
Time frame: Through study completion, an average of 1 year
specificity
Time frame: Through study completion, an average of 1 year
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 23 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 Primary Liver Cancer, run by Wuhan Ammunition Life-tech Co., Ltd 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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?
Contact Tingting Li, phD (+86 13317163570, litingting@amswh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 23 Mar 2026.