Correlation Study of Lipid Metabolites as Markers of Hepatocellular Carcinoma

As one of the common malignant tumors in China, primary liver cancer, whose incidence rate and mortality rate are always in the top five, is seriously threatening the health of people. Therefore, early diagnosis and treatment of primary liver cancer are of great significance. In recent years, the incidence of primary liver cancer, which is caused by hepatic steatosis or metabolic dysfunction-related liver disease, is increasing year by year, and it has become one of the fastest rising causes in some developed countries. More and more studies have also confirmed that the levels of different kinds of lipids and their metabolites are correlated with the development of hepatocellular carcinoma. In this study, the researchers performed qualitative and quantitative analyses of various common lipid metabolites in plasma and liver cancer tissues of hepatic resection patients with hepatocellular carcinoma, collected tumor-related pathological data from the patients, and investigated the correlation between the lipid metabolites and the development of hepatocellular carcinoma, in order to provide a new idea for the early diagnosis and treatment of primary hepatocellular carcinoma, as well as for screening of hepatocellular carcinoma markers.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Diagnostic test: diagnosed by traditional diagnostic markers（such as AFP or CT etc.）

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Kai Wang, Doctor; Phone Number: 13710574386; Email: kaiwang@smu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital
      • Contact: Kai Wang, Doctor; Phone Number: 13710574386; Email: kaiwang@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-80 years old undergoing hepatic resection for hepatocellular carcinoma (diagnostic criteria for hepatocellular carcinoma refer to the guidelines for the diagnosis and treatment of primary hepatocellular carcinoma).

Description

Inclusion Criteria:

• Patients aged 18-80 years old undergoing hepatic resection for hepatocellular carcinoma (diagnostic criteria for hepatocellular carcinoma refer to the guidelines for the diagnosis and treatment of primary hepatocellular carcinoma).
• Voluntary signing of informed consent

Exclusion Criteria:

• In the judgment of the investigator, they are not suitable to participate in this study.
• Patients with hepatic malignant tumors with invasion of the main portal vein and its first-order branches, the common hepatic duct and its first-order branches, the main hepatic vein and the inferior vena cava, or extrahepatic metastases.
• Surgery with biliary tract exploration or reconstruction in the presence of biliary obstruction.
• Surgery combined with splenectomy or splenic artery ligation
• Preoperative combination of cardiac, pulmonary, renal and other organs with major underlying diseases.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients diagnosed with hepatocellular carcinoma; Patients diagnosed with hepatocellular carcinoma according to the guidelines for the diagnosis of primary liver cancer	Diagnostic test: diagnosed by traditional diagnostic markers（such as AFP or CT etc.）; A prospective observational cohort study to explore the advantages of lipid metabolites as diagnostic markers for hepatocellular carcinoma compared to traditional diagnostic markers for hepatocellular carcinoma (e.g., AFP, enhanced CT, etc.).; Other Names: diagnosed by lipid metabolites
Patients diagnosed with non-hepatocellular carcinoma otherwise requiring hepatic resection; Patients who can be excluded from the diagnosis of hepatocellular carcinoma according to the guidelines for the diagnosis of primary liver cancer but required hepatic resection for other liver diseases	Diagnostic test: diagnosed by traditional diagnostic markers（such as AFP or CT etc.）; A prospective observational cohort study to explore the advantages of lipid metabolites as diagnostic markers for hepatocellular carcinoma compared to traditional diagnostic markers for hepatocellular carcinoma (e.g., AFP, enhanced CT, etc.).; Other Names: diagnosed by lipid metabolites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid Metabolite Levels	Lipids are extracted in the laboratory and sent to specialized laboratories for LC/MS non-targeted lipidomic assays to measure lipid metabolite levels in plasma and tissues.	Pre-operative and 1, 3 and 5 days post-operatively

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): June 30, 2032
• Study Completion (Estimated): July 1, 2032

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: NFEC-2024-361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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