cfDNA Methylation for Liver Cancer Recurrence Detection

NCT07466602 | Recruiting DMC

• 1 other identifier: AD07-2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Liver Cancer

Outcome Measures

Primary Outcomes (2)

• sensitivity

  Through study completion, an average of 1 year

• specificity

  Through study completion, an average of 1 year

Study Arms (1)

Primary liver cancer patients

Diagnostic Test: plasma GNB4 and Riplet genes methylation detection

Interventions

plasma GNB4 and Riplet genes methylation detection DIAGNOSTIC_TEST

Liver cancer patients undergo methylation testing at different follow-up time points after treatment

Primary liver cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Primary liver cancer

You may not qualify if:

• Concurrent other malignant tumors;
• Ineligible for hepatectomy, liver transplantation, ablation, or TACE therapy;
• Negative methylation status prior to treatment.

Sponsors & Collaborators

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

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Tingting Li, phD

CONTACT

+86 13317163570; litingting@amswh.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 12, 2026
• Study Start: September 2, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)