cfDNA Methylation for Liver Cancer Recurrence Detection

Clinical Study on the Combined Detection of Plasma GNB4 and Riplet Gene Methylation for Monitoring Primary Liver Cancer Recurrence

Through follow-up testing of patients with primary liver cancer who underwent hepatectomy, liver transplantation, ablation therapy, or transarterial chemoembolization (TACE), a blinded comparative trial was conducted at each monitoring site. This trial evaluated the combined methylation detection kit for GNB4 and Riplet genes (fluorescent PCR method) against the clinical reference standard (defined as the physician's comprehensive diagnosis based on clinical guidelines and other criteria). The study evaluated the clinical performance of the assay in diagnosing primary liver cancer recurrence and validated the clinical efficacy of methylation detection kits for monitoring recurrence after primary liver cancer treatment.

Study Overview

• Status: Recruiting
• Conditions: Primary Liver Cancer
• Intervention / Treatment: Diagnostic test: plasma GNB4 and Riplet genes methylation detection

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Tingting Li, phD; Phone Number: +86 13317163570; Email: litingting@amswh.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Zeyang Ding, MD; Phone Number: +86 13407156200; Email: zyding@tjh.tjmu.edu.cn
      • Principal Investigator: Wanguang Zhang, MD
      • Sub-Investigator: Zeyang Ding, MD
      • Sub-Investigator: Shuai Xiang, MD
      • Sub-Investigator: Zhao Huang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study investigates patients with primary liver cancer, encompassing three types: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and mixed liver cancer.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary liver cancer patients	Diagnostic test: plasma GNB4 and Riplet genes methylation detection; Liver cancer patients undergo methylation testing at different follow-up time points after treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
sensitivity	Through study completion, an average of 1 year
specificity	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Wuhan Ammunition Life-tech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: AD07-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No