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

NCT03307408 | Unknown

• 1 other identifier: 16-AOI-12
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Dosage of immunity cells in liver

  The investigators determine the stage of liver by biochemical, genetic (and immunocytochemistry methods.

  8 weeks

• Dosage of the inflammatory cells in liver

  The investigators determine the stage of liver by biochemical, genetic and immunocytochemistry methods.

  8 weeks

Secondary Outcomes (1)

• Dosage of the glucose

  8 weeks

Interventions

blood collection OTHER

Standard routine practice clinico-biological data will be collected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with alcoholic or non-alcoholic fatty liver diseases.

You may qualify if:

• Available social insurance
• Signed consent for the study enrollment
• Age ≥ 18 years

You may not qualify if:

• 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
• Available social insurance
• Signed consent for the study enrollment
• Age ≥ 18 years
• 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
• Available social insurance
• Signed consent for the study enrollment
• Age ≥ 18 years

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples, tissu samples, feces samples,

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rodolphe ANTY, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie MALERBA

CONTACT

+33492034011; drc@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: October 11, 2017
• Study Start: February 28, 2017
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: October 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)