Hepatocellular Carcinoma (HCC)CCGLC-019NCT07489768
GNB4 and Riplet Gene Methylation Combined Detection Kit for Hepatocellular Carcinoma Recurrence Monitoring
An observational study of Hepatocellular Carcinoma (HCC) and Hepatocellular Carcinoma Recurrent, run by Tongji Hospital.
Trial summary
This is a prospective, multicenter, observational longitudinal study designed to evaluate the clinical performance of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) for monitoring recurrence after treatment of hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma Recurrent
- What is being tested?
- GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR)
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jun 2029
- 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: Adults with confirmed or highly suspected primary hepatocellular carcinoma who are planned to undergo, are undergoing, or have undergone liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE), and who are followed for post-treatment recurrence monitoring.
Who may be able to join
- Participants must meet criterion (1) and any one of criteria (2) through (4):
- Adults aged 18 years or older;
- Patients with confirmed hepatocellular carcinoma or highly suspected hepatocellular carcinoma who are planned to undergo one or more of the following treatments: liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE);
- Patients who have previously received antitumor therapy but remain in a tumor-bearing state of hepatocellular carcinoma and are planned to undergo one or more of the following treatments: liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE);
- Post-treatment patients with primary hepatocellular carcinoma who have already undergone one or more of the following treatments: liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE), and whose result of the study assay before treatment was positive.
Who cannot join
- Patients with hepatocellular carcinoma who will not undergo any of the following treatments: liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE);
- Patients enrolled as highly suspected hepatocellular carcinoma whose final diagnosis according to the clinical reference standard is not primary hepatocellular carcinoma, or for whom it cannot be determined whether the disease is primary hepatocellular carcinoma;
- Patients whose samples collected before hepatocellular carcinoma treatment were not stored in accordance with protocol requirements;
- Patients whose samples collected before hepatocellular carcinoma treatment are insufficient in volume to meet the testing requirements.
- Any enrolled participant who is subsequently excluded from the clinical study will be documented, and the reason for exclusion will be clearly recorded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter Observational Clinical Study of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) for Post-treatment Recurrence Monitoring in Hepatocellular Carcinoma
This is a prospective, multicenter, observational longitudinal study designed to evaluate the clinical performance of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) for monitoring recurrence after treatment of hepatocellular carcinoma.
Adult patients with confirmed or highly suspected hepatocellular carcinoma who are planned to undergo, or have undergone, liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE) will be enrolled. Plasma samples will be collected before treatment and during follow-up after treatment. The test results of the study kit will be compared with the clinical reference standard, which is based on comprehensive clinical diagnosis according to routine practice and relevant guidelines.
The study aims to assess whether this methylation-based blood test can help identify recurrence of hepatocellular carcinoma after treatment. The main clinical performance measures include sensitivity in patients with recurrent disease, specificity in patients without recurrence, and overall agreement with the clinical reference standard.
Read the detailed description
Hepatocellular carcinoma (HCC) has a high risk of recurrence after treatment, and effective post-treatment monitoring is important for early detection and clinical management. This study is designed to evaluate the clinical effectiveness of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) for recurrence monitoring in patients with primary hepatocellular carcinoma after treatment.
This is a prospective, multicenter, observational longitudinal study. Eligible participants are adults aged 18 years or older with confirmed or highly suspected HCC who are scheduled to receive, or have already received, one or more of the following treatments: liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE). Patients will be followed according to routine clinical practice and relevant guideline recommendations.
Human plasma samples will be collected for testing with the study device. Samples may be obtained before treatment and at follow-up visits after treatment. The assay result from the GNB4 and Riplet methylation test will be compared in a blinded manner with the clinical reference standard. The clinical reference standard is the investigator's comprehensive assessment of recurrence status based on clinical evaluation, imaging, laboratory findings, and applicable diagnostic guidelines.
The primary purpose of the study is to evaluate the clinical performance of the study kit for identifying recurrence after treatment of HCC. Key performance measures include sensitivity for recurrent HCC, specificity for non-recurrent cases, overall agreement, and corresponding 95% confidence intervals. Participants with recurrence or metastasis may complete follow-up at the time recurrence is confirmed, while participants without recurrence will be followed for at least 6 months after initial treatment, with possible extension according to the protocol and clinical practice.
This study is intended to support clinical evaluation of the assay as a blood-based tool for post-treatment recurrence monitoring in hepatocellular carcinoma.
- Being tested
- GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR)
- Keywords
- Hepatocellular Carcinoma, Recurrence Monitoring, DNA Methylation, Circulating Cell-Free DNA, GNB4, Riplet, Real-time PCR
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR)Diagnostic test
Also called GNB4 and Riplet gene methylation test, GNB4/Riplet methylation assay
An in vitro qualitative real-time PCR assay used to detect methylation of the GNB4 and Riplet genes in circulating cell-free DNA (cfDNA) from human plasma samples. In this study, the assay is used for post-treatment recurrence monitoring in patients with hepatocellular carcinoma after liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE). Test results are compared with the clinical reference standard based on comprehensive clinical diagnosis during follow-up.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for recurrent hepatocellular carcinoma
Sensitivity of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) for identifying recurrent or metastatic hepatocellular carcinoma, using the clinical reference standard as the comparator.
Measured: At the end of follow-up, up to 12 months after treatment
Specificity for non-recurrent hepatocellular carcinoma
Specificity of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) in participants without recurrence, using the clinical reference standard as the comparator.
Measured: At the end of follow-up, up to 12 months after treatment
Overall agreement with the clinical reference standard
Overall agreement of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) with the clinical reference standard for recurrence monitoring in hepatocellular carcinoma.
Measured: At the end of follow-up, up to 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Ammunition Life-tech Co., Ltd
- Responsible party
- Principal investigator, Ze-yang Ding, MD, Tongji Hospital
- Investigators
- Wanguang Zhang, M.D., Principal investigator, Tongji HospitalZe-yang Ding, M.D., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489768
- Sponsor's protocol ID
- 2025-S281
- Acronym
- CCGLC-019
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo DZ, Huang A, Wang YC, Zhou S, Wang H, Xing XL, Zhang SY, Cheng JW, Xie KH, Yang QC, Ma CC, Li Q, Chen Y, Su ZX, Fan J, Liu R, Liu XL, Zhou J, Yang XR. Early detection and prognosis evaluation for hepatocellular carcinoma by circulating tumour DNA methylation: A multicentre cohort study. Clin Transl Med. 2024 May;14(5):e1652. doi: 10.1002/ctm2.1652.
PubMed 38741204Tsilimigras DI, Bagante F, Sahara K, Moris D, Hyer JM, Wu L, Ratti F, Marques HP, Soubrane O, Paredes AZ, Lam V, Poultsides GA, Popescu I, Alexandrescu S, Martel G, Workneh A, Guglielmi A, Hugh T, Aldrighetti L, Endo I, Pawlik TM. Prognosis After Resection of Barcelona Clinic Liver Cancer (BCLC) Stage 0, A, and B Hepatocellular Carcinoma: A Comprehensive Assessment of the Current BCLC Classification. Ann Surg Oncol. 2019 Oct;26(11):3693-3700. doi: 10.1245/s10434-019-07580-9. Epub 2019 Jul 2.
PubMed 31267302Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31.
PubMed 29395269Pizzato M, Li M, Vignat J, Laversanne M, Singh D, La Vecchia C, Vaccarella S. The epidemiological landscape of thyroid cancer worldwide: GLOBOCAN estimates for incidence and mortality rates in 2020. Lancet Diabetes Endocrinol. 2022 Apr;10(4):264-272. doi: 10.1016/S2213-8587(22)00035-3. Epub 2022 Mar 7.
PubMed 35271818
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Observational Clinical Study of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) for Post-treatment Recurrence Monitoring in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07489768
- Acronym / sponsor ID
- CCGLC-019 / 2025-S281
- Keywords
- Hepatocellular Carcinoma, Recurrence Monitoring, DNA Methylation, Circulating Cell-Free DNA, GNB4, Riplet, Real-time PCR
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Wuhan Ammunition Life-tech Co., Ltd
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 24 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.
This is a prospective, multicenter, observational longitudinal study designed to evaluate the clinical performance of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) for monitoring recurrence after treatment of hepatocellular carcinoma.
Adult patients with confirmed or highly suspected hepatocellular carcinoma who are planned to undergo, or have undergone, liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE) will be enrolled. Plasma samples will be collected before treatment and during follow-up after treatment. The test results of the study kit will be compared with the clinical reference standard, which is based on comprehensive clinical diagnosis according to routine practice and relevant guidelines.
The study aims to assess whether this methylation-based blood test can help identify recurrence of hepatocellular carcinoma after treatment. The main clinical performance measures include sensitivity in patients with recurrent disease, specificity in patients without recurrence, and overall agreement with the clinical reference standard.
Detailed description
Hepatocellular carcinoma (HCC) has a high risk of recurrence after treatment, and effective post-treatment monitoring is important for early detection and clinical management. This study is designed to evaluate the clinical effectiveness of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) for recurrence monitoring in patients with primary hepatocellular carcinoma after treatment.
This is a prospective, multicenter, observational longitudinal study. Eligible participants are adults aged 18 years or older with confirmed or highly suspected HCC who are scheduled to receive, or have already received, one or more of the following treatments: liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE). Patients will be followed according to routine clinical practice and relevant guideline recommendations.
Human plasma samples will be collected for testing with the study device. Samples may be obtained before treatment and at follow-up visits after treatment. The assay result from the GNB4 and Riplet methylation test will be compared in a blinded manner with the clinical reference standard. The clinical reference standard is the investigator's comprehensive assessment of recurrence status based on clinical evaluation, imaging, laboratory findings, and applicable diagnostic guidelines.
The primary purpose of the study is to evaluate the clinical performance of the study kit for identifying recurrence after treatment of HCC. Key performance measures include sensitivity for recurrent HCC, specificity for non-recurrent cases, overall agreement, and corresponding 95% confidence intervals. Participants with recurrence or metastasis may complete follow-up at the time recurrence is confirmed, while participants without recurrence will be followed for at least 6 months after initial treatment, with possible extension according to the protocol and clinical practice.
This study is intended to support clinical evaluation of the assay as a blood-based tool for post-treatment recurrence monitoring in hepatocellular carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with confirmed or highly suspected primary hepatocellular carcinoma who are planned to undergo, are undergoing, or have undergone liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE), and who are followed for post-treatment recurrence monitoring.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older;
- Patients with confirmed hepatocellular carcinoma or highly suspected hepatocellular carcinoma who are planned to undergo one or more of the following treatments: liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE);
- Patients who have previously received antitumor therapy but remain in a tumor-bearing state of hepatocellular carcinoma and are planned to undergo one or more of the following treatments: liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE);
- Post-treatment patients with primary hepatocellular carcinoma who have already undergone one or more of the following treatments: liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE), and whose result of the study assay before treatment was positive.
Key exclusion criteria (5 listed)
- Patients with hepatocellular carcinoma who will not undergo any of the following treatments: liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE);
- Patients enrolled as highly suspected hepatocellular carcinoma whose final diagnosis according to the clinical reference standard is not primary hepatocellular carcinoma, or for whom it cannot be determined whether the disease is primary hepatocellular carcinoma;
- Patients whose samples collected before hepatocellular carcinoma treatment were not stored in accordance with protocol requirements;
- Patients whose samples collected before hepatocellular carcinoma treatment are insufficient in volume to meet the testing requirements.
- Any enrolled participant who is subsequently excluded from the clinical study will be documented, and the reason for exclusion will be clearly recorded.
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 |
|---|---|---|
| GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR)Also: GNB4 and Riplet gene methylation test, GNB4/Riplet methylation assayAn in vitro qualitative real-time PCR assay used to detect methylation of the GNB4 and Riplet genes in circulating cell-free DNA (cfDNA) from human plasma samples. In this study, the assay is used for post-treatment recurrence monitoring in patients with hepatocellular carcinoma after liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE). Test results are compared with the clinical reference standard based on comprehensive clinical diagnosis during follow-up. | Diagnostic test | – |
Primary outcome
Sensitivity for recurrent hepatocellular carcinoma
Time frame: At the end of follow-up, up to 12 months after treatment
Sensitivity of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) for identifying recurrent or metastatic hepatocellular carcinoma, using the clinical reference standard as the comparator.
Specificity for non-recurrent hepatocellular carcinoma
Time frame: At the end of follow-up, up to 12 months after treatment
Specificity of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) in participants without recurrence, using the clinical reference standard as the comparator.
Overall agreement with the clinical reference standard
Time frame: At the end of follow-up, up to 12 months after treatment
Overall agreement of the GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) with the clinical reference standard for recurrence monitoring in hepatocellular carcinoma.
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 24 Mar 2026.
- Background: PubMed 38741204Guo DZ, Huang A, Wang YC, Zhou S, Wang H, Xing XL, Zhang SY, Cheng JW, Xie KH, Yang QC, Ma CC, Li Q, Chen Y, Su ZX, Fan J, Liu R, Liu XL, Zhou J, Yang XR. Early detection and prognosis evaluation for hepatocellular carcinoma by circulating tumour DNA methylation: A multicentre cohort study. Clin Transl Med. 2024 May;14(5):e1652. doi: 10.1002/ctm2.1652.
- Background: PubMed 31267302Tsilimigras DI, Bagante F, Sahara K, Moris D, Hyer JM, Wu L, Ratti F, Marques HP, Soubrane O, Paredes AZ, Lam V, Poultsides GA, Popescu I, Alexandrescu S, Martel G, Workneh A, Guglielmi A, Hugh T, Aldrighetti L, Endo I, Pawlik TM. Prognosis After Resection of Barcelona Clinic Liver Cancer (BCLC) Stage 0, A, and B Hepatocellular Carcinoma: A Comprehensive Assessment of the Current BCLC Classification. Ann Surg Oncol. 2019 Oct;26(11):3693-3700. doi: 10.1245/s10434-019-07580-9. Epub 2019 Jul 2.
- Background: PubMed 29395269Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31.
- Background: PubMed 35271818Pizzato M, Li M, Vignat J, Laversanne M, Singh D, La Vecchia C, Vaccarella S. The epidemiological landscape of thyroid cancer worldwide: GLOBOCAN estimates for incidence and mortality rates in 2020. Lancet Diabetes Endocrinol. 2022 Apr;10(4):264-272. doi: 10.1016/S2213-8587(22)00035-3. Epub 2022 Mar 7.
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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.
Wanguang Zhang, M.D. principal investigator
Tongji Hospital
Ze-yang Ding, M.D. principal investigator
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC) and Hepatocellular Carcinoma Recurrent, run by Tongji Hospital.
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: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ze-yang Ding (13407156200, zyding@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity for recurrent hepatocellular carcinoma (time frame: At the end of follow-up, up to 12 months after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07489768, which also lists 4 linked publications.
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 24 Mar 2026.