CHronic Hepatopathies Associated with ALcohol Consumption and MetAbolic Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Criteria common to all patients:

‣ Affiliation to French social security.

⁃ Male or female ≥ 18 years of age

⁃ Patients able to receive and understand information about the research and to give written informed consent duly signed by the patient and the investigator (at the latest on the day of inclusion and before any examination necessary for the research).

• Patients in the NAFLD group with HCC:

‣ Alcohol consumption ≤ 30 g pure alcohol/d (or 210 g pure alcohol/week) for men and ≤ 20 g pure alcohol/d (140 g pure alcohol/week) for women.

⁃ Decision, less than 3 months old, of liver biopsy of the suspected HCC nodule and non-tumour liver tissue performed as a clinical routine.

⁃ No systemic treatment for HCC within 6 months prior to inclusion.

• Patients in the NAFLD group without HCC:

‣ Alcohol consumption ≤ 30 g pure alcohol/d (or 210 g pure alcohol/week) for men and ≤ 20 g pure alcohol/d (140 g pure alcohol/week) for women.

⁃ Decision of less than 3 months of a liver biopsy performed as a clinical routine. Biopsy will be motivated by liver function disturbance(s) and/or ultrasound steatosis given the lack of validated non-invasive tests or the lack of accuracy (grey areas) of available non-invasive tests for the diagnosis of necro-inflammation and/or fibrosis in some of these patients.

• Patients in the alcohol-related liver disease group with HCC:

‣ Alcohol consumption \> 30 g pure alcohol/d (or 210 g pure alcohol/week) for men and \> 20 g pure alcohol/d (140 g pure alcohol/week) or binge drinking

⁃ Decision within 3 months of liver biopsy of suspected HCC nodule and non-tumour liver tissue performed as part of clinical routine

⁃ No systemic treatment for HCC within 6 months prior to inclusion.

• Patients in the alcohol-related liver disease group without HCC:

‣ Alcohol consumption \> 30 g pure alcohol/d (or 210 g pure alcohol/week) for men and \> 20 g pure alcohol/d (140 g pure alcohol/week) or binge drinking

⁃ Decision of less than 3 months for a liver biopsy to be performed as a clinical routine. Biopsy will be motivated by liver balance disturbance(s) and/or ultrasound steatosis given the lack of validated non-invasive tests or the lack of accuracy (grey areas) of available non-invasive tests for the diagnosis of necro-inflammation and/or fibrosis in some of these patients.

Locations
Other Locations
France
Batiment Archimed 151, route de Saint Antoine de Ginestière
RECRUITING
Nice
Contact Information
Primary
Rodolphe Anty, MD, PhD
anty.r@chu-nice.fr
0033492035943
Time Frame
Start Date: 2022-12-06
Estimated Completion Date: 2032-03
Participants
Target number of participants: 710
Treatments
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:~* 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.
Sponsors
Leads: Institut National de la Santé Et de la Recherche Médicale, France
Collaborators: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov