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NCT Number: NCT07466602

cfDNA Methylation for Liver Cancer Recurrence Detection

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.

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Key information

Conditions

Primary Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Shuai Xiang, MD

SUB_INVESTIGATOR

Wanguang Zhang, MD

PRINCIPAL_INVESTIGATOR

Zeyang Ding, MD

CONTACT

[email protected]

+86 13407156200

Zeyang Ding, MD

SUB_INVESTIGATOR

Zhao Huang, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

plasma GNB4 and Riplet genes methylation detection

Diagnostic Test

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

Primary outcomes

  1. sensitivity

    Time frame: Through study completion, an average of 1 year

  2. specificity

    Time frame: Through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Tingting Li, phD

CONTACT

[email protected]

+86 13317163570

Sponsors and collaborators

Lead sponsor

Wuhan Ammunition Life-tech Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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