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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire de Nice | OTHER |
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The aim is to determine the metabolic factors, host immune factors, and medical imaging data associated with the development of HepatoCellular Carcinoma (HCC) in patients with alcohol-related liver disease or dysmetabolic steatosis/Non-Alcoholic SteatoHepatitis.
The investigators will include patients with and without cirrhosis in order to identify early molecular mechanisms involved in the development of HCC especially in non-cirrhotic patients.
Type and methodology of the research:
Within the framework of the usual management of the patient's pathology, a clinico-biological characterization (dietary and physical activity questionnaires, "performans status", anthropometric measurements, usual blood biology characterizing the hepatic, renal and inflammatory function, the carbohydrate and lipid metabolism, the non invasive test for liver fibrosis ELF etc.) will be carry out. In order to collect radiomic data, liver imaging (particularly in case of HCC) will be done.
A liver biopsy and constitution of a biobank (samples of plasma, sera, DNA and leucocyte pellets) will be performed.
The elements necessary for the classification of possible hepatocellular carcinomas (BCLC classification) will be collected.
Anticipated research schedule:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Descriptive study | The patients included in this observational study are patients with hepatic steatosis either related to NAFLD or to alcohol-related liver disease. Patients included in the study may have hepatocellular carcinoma. Thus, 4 groups of patients can be recruited:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver biopsy | Diagnostic Test | Liver biopsy planned as part of routine care. Clinical-biological characterisation with bio collections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome measure CHALNA2 | The primary endpoint will be the study of variations in metabolic gene markers (i.e. mRNA of genes implicated in inflammation or metabolism assessed in qPCR, using a housekeeping gene such as glyceraldehyde-3-phosphate dehydrogenase (GAPDH)), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage. | 2022-2032 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome measure CHALNA2 | Secondary endpoint will include variations in other gene markers (e.g. genes implicated in the regeneration, cell deaths and tumor, assessed in qPCR, using a housekeeping gene such as glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) in patients with and without hepatocellular carcinoma with different levels of severity of liver damage. | 2022-2032 |
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Inclusion Criteria:
Criteria common to all patients:
Patients in the NAFLD group with HCC:
Patients in the NAFLD group without HCC:
Patients in the alcohol-related liver disease group with HCC:
Patients in the alcohol-related liver disease group without HCC:
Exclusion Criteria:
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The patients included in this observational study are patients with hepatic steatosis either related to NAFLD or to alcohol-related liver disease.
Patients included in the study may have hepatocellular carcinoma. Thus, 4 groups of patients can be recruited: patients with NAFLD without hepatocellular carcinoma, patients with NAFLD with hepatocellular carcinoma, patients with alcohol-related liver disease without hepatocellular carcinoma, patients with alcohol-related liver disease with hepatocellular carcinoma.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodolphe Anty, MD, PhD | Contact | 0033492035943 | anty.r@chu-nice.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Batiment Archimed 151, route de Saint Antoine de Ginestière | Recruiting | Nice | France |
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standard liver biopsy (for immunocytochemistry), frozen liver biopsy, frozen serum, frozen plasma, DNA
| 3th outcome measure CHALNA2 | 3th endpoint will include variations in genetic markers (Single Nucleotide Polymorphisms (SNPs)), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage. The frequency of SNPs will be compared to that found in the UK biobank cohort. | 2022-2032 |
| 4th outcome measure CHALNA2 | 4th endpoint will include variations in epigenetic markers (histone methylation, micro RNA), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage. | 2022-2032 |
| 5th outcome measure CHALNA2 | 5th endpoint will include variations in tissue proteins (including tumor and non tumor tissue), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage. Western blots will be quantified and compared in an automated way. | 2022-2032 |
| 6th outcome measure CHALNA2 | 6th endpoint will include variations in specific markers or markers derived from analysis via platforms (OMICS), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage. | 2022-2032 |
| 7th outcome measure CHALNA2 | 7th endpoint will include variations in radiomics (radiomics is a method that extracts a large number of features from medical images using data-characterisation algorithms), in patients with and without hepatocellular carcinoma with different levels of severity of liver damage. | 2022-2032 |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008103 | Liver Cirrhosis |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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