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

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.

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.

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.