GNB4 and Riplet Gene Methylation Combined Detection Kit for Hepatocellular Carcinoma Recurrence Monitoring (CCGLC-019)

March 18, 2026 updated by: Ze-yang Ding, MD, Tongji Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of follow-up, up to 12 months after treatment
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.
At the end of follow-up, up to 12 months after treatment
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.
At the end of follow-up, up to 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

Wuhan Ammunition Life-tech Co., Ltd

Investigators

  • Principal Investigator: Ze-yang Ding, M.D., Tongji Hospital
  • Principal Investigator: Wanguang Zhang, M.D., Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-S281

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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