GNB4 and Riplet Gene Methylation Combined Detection Kit for Hepatocellular Carcinoma Recurrence Monitoring
Sponsored by Tongji Hospital
About this trial
Last updated 24 days ago
Study ID
2025-S281
Status
Not yet recruiting
Type
Observational
Placebo
No
Accepting
18+ Years
All Sexes
Trial Timing
Started 16 days ago
What is this trial about?
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.
What are the participation requirements?
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.