Plasma methylation test for detecting liver cancer recurrence (GNB4 and Riplet)
Clinical Study on the Combined Detection of Plasma GNB4 and Riplet Gene Methylation for Monitoring Primary Liver Cancer Recurrence
This test sees if a blood-based methylation assay measuring GNB4 and Riplet can detect return of primary liver cancer in people who had hepatectomy, liver transplant, ablation, or TACE.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wuhan Ammunition Life-tech Co., Ltd Industry-sponsored |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07466602 on ClinicalTrials.gov |
What this trial studies
This observational, blinded comparative protocol followed patients with primary liver cancer after hepatectomy, liver transplantation, ablation, or TACE and measured plasma methylation of GNB4 and Riplet using a fluorescent PCR kit. Results from the methylation kit were compared, with site blinding, to a clinical reference standard defined by the treating physician's comprehensive diagnosis based on guidelines and other clinical data. The main goal was to characterize the assay's clinical performance for diagnosing recurrence and to validate its use for post-treatment monitoring. Exclusions included concurrent other malignancies, ineligibility for the listed therapies, or negative methylation status before treatment, and the work was conducted at Tongji Hospital in Wuhan.
Who should consider this trial
Good fit: Ideal candidates are people with primary liver cancer who underwent hepatectomy, liver transplantation, ablation, or TACE and had positive methylation status before treatment.
Not a fit: Patients with other concurrent malignancies, those not eligible for the listed therapies, or those who were methylation-negative prior to treatment are unlikely to benefit from this assay.
Why it matters
Potential benefit: If successful, this blood methylation test could allow earlier, less invasive detection of liver cancer recurrence and support faster treatment decisions.
How similar studies have performed: Other cfDNA methylation approaches for hepatocellular carcinoma surveillance have shown promise in prior studies, though marker panels and levels of clinical validation vary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary liver cancer Exclusion Criteria: * Concurrent other malignant tumors; * Ineligible for hepatectomy, liver transplantation, ablation, or TACE therapy; * Negative methylation status prior to treatment.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Tingting Li, phD
- Email: litingting@amswh.com
- Phone: +86 13317163570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.