Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT05623150
Eligibility Criteria:
Inclusion Criteria:
* Criteria common to all patients:
1. Affiliation to French social security.
2. Male or female ≥ 18 years of age
3. 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:
1. 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.
2. Decision, less than 3 months old, of liver biopsy of the suspected HCC nodule and non-tumour liver tissue performed as a clinical routine.
3. No systemic treatment for HCC within 6 months prior to inclusion.
* Patients in the NAFLD group without HCC:
1. 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.
2. 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:
1. 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
2. Decision within 3 months of liver biopsy of suspected HCC nodule and non-tumour liver tissue performed as part of clinical routine
3. No systemic treatment for HCC within 6 months prior to inclusion.
* Patients in the alcohol-related liver disease group without HCC:
1. 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
2. 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.
Exclusion Criteria:
1. Positive HIV serology
2. Patients with detectable hepatitis C viral load
3. Presence of Hbs antigen
4. History of autoimmune hepatitis type 1 or 2, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, genetic haemochromatosis homozygous, alpha1 anti-trypsin deficiency
5. Long-term use of methotrexate, corticosteroids, anti-Tumor Necrosis Factor cyclosporine, tacrolimus
6. History of solid organ transplantation or bone marrow transplantation
7. Cancerous disease in the process of being treated, except for skin cancer (excluding melanoma)
8. Patients under legal protection or unable to express their consent,
9. Pregnant or breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05623150
Study Brief:
Protocol Section:
NCT05623150