Correlation Study of Lipid Metabolites as Markers of Hepatocellular Carcinoma

October 7, 2024 updated by: Nanfang Hospital, Southern Medical University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lipid Metabolite Levels
Time Frame: Pre-operative and 1, 3 and 5 days post-operatively
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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