Correlation Study of Lipid Metabolites as Markers of Hepatocellular Carcinoma

NCT06623474 | Recruiting

• 1 other identifier: NFEC-2024-361
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.）

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.）

Interventions

diagnosed by traditional diagnostic markers（such as AFP or CT etc.） DIAGNOSTIC_TEST

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.).

Also known as: diagnosed by lipid metabolites

Patients diagnosed with hepatocellular carcinoma; Patients diagnosed with non-hepatocellular carcinoma otherwise requiring hepatic resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (1)

• Lei Y, Xie C, Mo X, Zhuang B, Li Q, Liu C, Liao L, Wang B, Zeng M, Tang S, Liu H, Xiao Y, Li S, Cai D, Li C, Zhou J, Li J, Li Y, Wang K. Preoperative plasma ceramide profiling coupled with machine learning accurately predicts recurrence of hepatocellular carcinoma after resection. Lipids Health Dis. 2025 Nov 6;24(1):355. doi: 10.1186/s12944-025-02749-6.

  PMID: 41194075 DERIVED

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

Kai Wang, Doctor

CONTACT

13710574386; kaiwang@smu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2032
• Study Completion (Estimated): July 1, 2032
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

CN (1)