GNB4 and Riplet Gene Methylation Combined Detection Kit for Hepatocellular Carcinoma Recurrence Monitoring

NCT07489768 | Not Yet Recruiting

• 1 other identifier: 2025-S281
• Study Type: observational
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Hepatocellular Carcinoma (HCC); Hepatocellular Carcinoma Recurrent

Keywords

Hepatocellular Carcinoma; Recurrence Monitoring; DNA Methylation; Circulating Cell-Free DNA; GNB4; Riplet; Real-time PCR

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At the end of follow-up, up to 12 months after treatment

Interventions

GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR) DIAGNOSTIC_TEST

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.

Also known as: GNB4 and Riplet gene methylation test, GNB4/Riplet methylation assay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead
• Wuhan Ammunition Life-tech Co., Ltd: collaborator

Related Publications (4)

• 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.

  PMID: 38741204 BACKGROUND

• Tsilimigras 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.

  PMID: 31267302 BACKGROUND

• Allemani 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.

  PMID: 29395269 BACKGROUND

• Pizzato 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.

  PMID: 35271818 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Wanguang Zhang, M.D.

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Ze-yang Ding, M.D.

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ze-yang Ding

CONTACT

13407156200; zyding@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 24, 2026

Record last verified: 2026-03