Batiment Archimed 151, route de Saint Antoine de Ginestière
Nice, France
Location status: Recruiting
NCT Number: NCT05623150
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Nice, France
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Liver biopsy planned as part of routine care. Clinical-biological characterisation with bio collections.
Time frame: 2022-2032
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.
Time frame: 2022-2032
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.
Time frame: 2022-2032
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.
Time frame: 2022-2032
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.
Time frame: 2022-2032
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.
Time frame: 2022-2032
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.
Time frame: 2022-2032
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.
Contact information is provided by the study sponsor or research team.
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
Acronym: CHALNA2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05870969
Adenocarcinoma, Blood-Borne Infections
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT06138821
Body Weight, Body Weight Changes
Boston, Massachusetts, United States
View Trial DetailsNCT04666402
Alcohol-Induced Disorders, Alcohol-Related Disorders
Manchester, Greater Manchester, United Kingdom
View Trial DetailsNCT04190849
Adenocarcinoma, Arterial Occlusive Diseases
Maastricht, Netherlands
View Trial Details