Hepatocellular Carcinoma in Patients With a Cirrhosis Due to an Alcoholic or a Non Alcoholic Fatty Liver Disease

Hepatocellular Carcinoma Clinical Trial

— CHALNA  

Official title:

Hepatocellular Carcinoma in Patients With a Cirrhosis Due to an Alcoholic or a Non Alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03307408
• Other study ID #: 16-AOI-12
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2017
• Last updated: October 2, 2017
• Start date: February 28, 2017
• Est. completion date: February 2020

Study information

• Verified date: September 2017
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Sylvie MALERBA
• Phone: +33492034011
• Email: drc[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Global prevalence of Non Alcoholic Fatty Liver Diseases (NAFLD) ranges from 22% to 28%.The spectrum of these hepatic abnormalities extends from isolated steatosis to steatohepatitis (Non Alcoholic Steato-Hepatitis, NASH) and steatofibrosis leading to cirrhosis and hepatocellular carcinoma. NAFLD is one of the main causes of cirrhosis and increases the risk of liver-related death and hepatocellular carcinoma (developed in patients with or without cirrhosis). Despite this major public health concern, apart from lifestyle changes, treatment of NAFLD is still elusive as there is lack of efficacious pharmacological treatment. Alcoholic liver diseases are also frequent in Western countries. Alcoholic liver diseases and NAFLD share common pathological lesions and molecular pathways. This is illustrated by the emerging role of abnormalities of the microbiota (dysbiosis) in these 2 diseases leading to the concept of " liver-gut axis ". Whereas the molecular mechanisms responsible for the progression from a "safety" state to NASH or to a severe alcoholic steato-hepatitis are still unclear, hepatic inflammation is a key factor involved in the progression of NAFLD and alcoholic liver disease.

The hypothesis is that cellular and molecular abnormalities and gut dysbiosis could be present in patients with simple steatosis or with steato-hepatitis and could be responsible for the occurrence of hepatocellular carcinoma particularly without cirrhosis.

The main objective is to compare cellular and inflammatory pathways in liver with and without hepatocellular carcinoma in patients with alcoholic or non-alcoholic fatty liver diseases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Group 1

Inclusion Criteria :

• Available social insurance

• Signed consent for the study enrollment

• Age = 18 years

Exclusion Criteria :

• Patients in the group with metabolic fatty liver with hepatocellular carcinoma

• Alcohol consumption = 30 g/d (or 210 g/week) in men and = 20 g/d (or 140 g/week) in women.

• Decision (less than 3 months) to perform a liver biopsy of a tumor suspect of HCC and of adjacent liver in routine practice.

• No systemic HCC treatment in the previous 6 months

Group 2

Inclusion Criteria :

• Available social insurance

• Signed consent for the study enrollment

• Age = 18 years

Exclusion Criteria :

• Patients in the group with metabolic fatty liver without hepatocellular carcinoma

• Alcohol consumption = 30 g/d (or 210 g/week) in men and = 20 g/d (or 140 g/week) in women.

• Decision (less than 3 months) to perform a liver biopsy in routine practice. Liver biopsy will be organized because of one or more liver abnormalities and/or fatty liver seen at liver ultrasound due to the current lack of validated non-invasive marker of inflammation, cellular death and fibrosis in these patients.

Group 3

Inclusion Criteria :

• Available social insurance

• Signed consent for the study enrollment

• Age = 18 years

Exclusion Criteria :

• Patients with an alcoholic liver disease with hepatocellular carcinoma

• Alcohol consumption > 30 g/d (or 210 g/week) in men and > 20 g/d (or 140 g/week) in women.

• Decision (less than 3 months) to perform a liver biopsy of a tumor suspect of HCC and of adjacent liver in routine practice.

• No systemic HCC treatment in the previous 6 months

Group 4

Inclusion Criteria :

• Available social insurance

• Signed consent for the study enrollment

• Age = 18 years

Exclusion Criteria :

• Patients with an alcoholic liver disease without hepatocellular carcinoma

• Alcohol consumption > 30 g/d (or 210 g/week) in men and > 20 g/d (or 140 g/week) in women.

• Decision (less than 3 months) to perform a liver biopsy in routine practice. No systemic HCC treatment in the previous 6 months. Liver biopsy will be organized because of one or more liver abnormalities and/or fatty liver seen at liver ultrasound due to the current lack of validated non-invasive marker of inflammation, cellular death and fibrosis in these patients.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Fatty Liver
• Hepatocellular Carcinoma
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• blood collection
Standard routine practice clinico-biological data will be collected

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of immunity cells in liver	The investigators determine the stage of liver by biochemical, genetic (and immunocytochemistry methods.	8 weeks
Primary	Dosage of the inflammatory cells in liver	The investigators determine the stage of liver by biochemical, genetic and immunocytochemistry methods.	8 weeks
Secondary	Dosage of the glucose	The investigators determine the genes implicated in oxidative stress, reticulum endoplasmic stress and autophagy .	8 weeks