GNB4 and Riplet Gene Methylation Combined Detection Kit for Hepatocellular Carcinoma Recurrence Monitoring
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
GNB4 and Riplet Gene Methylation Combined Detection Kit (Real-time PCR)
Diagnostic testAn 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
At the end of follow-up, up to 12 months after treatment2
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.
Time frame
At the end of follow-up, up to 12 months after treatment3
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.
Time frame
At the end of follow-up, up to 12 months after treatmentLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tongji Hospital
Lead sponsor
Wuhan Ammunition Life-tech Co., Ltd
Collaborator
Source ClinicalTrials.gov
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