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

NCT07489768 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 162

Last updated 2026-03-24

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

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.

Sponsors & Collaborators

  • Wuhan Ammunition Life-tech Co., Ltd

    collaborator INDUSTRY

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Wanguang Zhang, M.D. · Tongji Hospital

  • Ze-yang Ding, M.D. · Tongji Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-12-31
Completion
2029-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07489768 on ClinicalTrials.gov