NCT07489768Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 162 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Tongji Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07489768
What you commit to
- Study type: Observational
- Planned participants: 162
- From 1 Apr 2026 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with hepatocellular carcinoma who will not undergo any of the following treatments: liver resection, liver transplantation, ablation, or transarterial chemoembolization (TACE);
Other illness
- 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;
Other
- 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.
- Any enrolled participant who is subsequently excluded from the clinical study will be documented, and the reason for exclusion will be clearly recorded.
Who the study is looking for
- Participants must meet criterion (1) and any one of criteria (2) through (4):
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.