Clinical trial · Observational

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

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

NCT07489768CI-TRIAL-00106292CCGLC-019not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Hepatocellular Carcinoma (HCC)	Hepatocellular Carcinoma	ONTOLOGY_EXACT	0.85
Hepatocellular Carcinoma Recurrent	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR)	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (3)

measure
Sensitivity for recurrent hepatocellular carcinoma
timeFrame
At the end of follow-up, up to 12 months after treatment
description
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.
measure
Specificity for non-recurrent hepatocellular carcinoma
timeFrame
At the end of follow-up, up to 12 months after treatment
description
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.
measure
Overall agreement with the clinical reference standard
timeFrame
At the end of follow-up, up to 12 months after treatment
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

Participants must meet criterion (1) and any one of criteria (2) through (4):

1. Adults aged 18 years or older;
2. 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);
3. 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);
4. 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.

Exclusion Criteria:

1. Patients with hepatocellular carcinoma who will not undergo any of the following treatments: liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE);
2. 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;
3. Patients whose samples collected before hepatocellular carcinoma treatment were not stored in accordance with protocol requirements;
4. 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.

References

Publications (4)

BACKGROUNDGuo 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
BACKGROUNDTsilimigras 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
BACKGROUNDAllemani 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
BACKGROUNDPizzato 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