Hepatocellular CarcinomaNCT06623474
Correlation Study of Lipid Metabolites as Markers of Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- diagnosed by traditional diagnostic markers（such as AFP or CT etc.）
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Jul 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Kai Wang, Doctor, 13710574386, kaiwang@smu.edu.cn
About this study
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
- Being tested
- diagnosed by traditional diagnostic markers（such as AFP or CT etc.）
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosed by traditional diagnostic markers（such as AFP or CT etc.）Diagnostic test
Also called diagnosed by lipid metabolites
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.).
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with hepatocellular carcinoma | Patients diagnosed with hepatocellular carcinoma according to the guidelines for the diagnosis of primary liver cancer Receives: 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 Receives: Diagnostic Test: diagnosed by traditional diagnostic markers（such as AFP or CT etc.） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-operative and 1, 3 and 5 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2032 (estimated)
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623474
- Sponsor's protocol ID
- NFEC-2024-361
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41194075
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Study of Lipid Metabolites as Markers of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06623474
- Acronym / sponsor ID
- NFEC-2024-361
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2032 (estimated)
- Study completion
- 1 Jul 2032 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with hepatocellular carcinoma | – | Diagnostic Test: diagnosed by traditional diagnostic markers（such as AFP or CT etc.）Patients diagnosed with hepatocellular carcinoma according to the guidelines for the diagnosis of primary liver cancer |
| Patients diagnosed with non-hepatocellular carcinoma otherwise requiring hepatic resection | – | Diagnostic Test: diagnosed by traditional diagnostic markers（such as AFP or CT etc.）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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosed by traditional diagnostic markers（such as AFP or CT etc.）Also: diagnosed by lipid metabolitesA 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.). | Diagnostic test | Patients diagnosed with hepatocellular carcinoma, Patients diagnosed with non-hepatocellular carcinoma otherwise requiring hepatic resection |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Derived from this study: PubMed 41194075Lei 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, Doctor (13710574386, kaiwang@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Metabolite Levels (time frame: Pre-operative and 1, 3 and 5 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06623474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.