The MAI-FOIE Cohort

NCT07594990 | Not Yet Recruiting

• 2 other identifiers: RC24_06192026-A00236-45
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The MAI-FOIE cohort will be a French multicenter cohort with the development of a biobank including patients with autoimmune, metabolic and medicated liver diseases

Conditions

Autoimmune Liver Diseases; Immunological Mechanisms

Keywords

Cohort; biocollection; pathophysiology; biomarkers

Outcome Measures

Primary Outcomes (1)

• Identification of new immune, cellular and molecular markers in patients who respond and not respond to treatment

  Comparative studies of clinical, biological, genetic (HLA typing) parameters and result from omics analysis of patients groups classified according to their response to treatment and disease progression

  2 years

Secondary Outcomes (1)

• Understanding the molecular mechanisms of treatment efficacy and failure

  2 years

Study Arms (2)

AIH patients

Patients of both sexes, over 10 years old, with an established diagnosis of AIH (Auto Immune Hepatitis) will be eligible for inclusion during a medical care visit.

Control patients

Patients of both sexes, over 18 years old, with an established diagnosis of Primary Biliary Cholangitis, Metabolic Steatohepatitis or Drug-Induced Hepatitis will be eligible for inclusion during a medical care visit

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from 10 years old to patients without limit age, male or female, with Auto-Immune Hepatitis or Metabolic steatohepatitis or Drug induced Hepatitis

You may qualify if:

• age≥10 years old
• weight≥25kg
• AIH (with or without the presence of an overlap) whose diagnosis is validated by at least 2 of the following criteria :
• ALT\>2N or IgG\>1.1N
• Presence of autoantibodies : ANA (antinuclear), ML (anti-smooth muscle), SLA (anti-soluble liver antigen), LKM1 (anti-endoplasmic reticulum), LC1 (anti-liver cytosol)
• Presence of interface hepatitis on biopsy
• signing of a written consent form for participation in the study and for the storage of biological samples research
• Control patients :
• age≥18 years old
• weight≥37kg
• Patient with one of the following 3 conditions :
• Primary Biliary Cholangitis
• Metabolic steatohepatitis
• Drug induced hepatitis

You may not qualify if:

• Positive HIV serology HBV infection Positive HCV serology and PCR Patients under guardianship or curatorship

Sponsors & Collaborators

• Nantes University Hospital: lead
• Direction Générale de l'Offre de Soins: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• National Cancer Institute, France: collaborator
• Association Française pour l'Etude du Foie (AFEF): collaborator
• ALBI: collaborator
• FILFOIE: collaborator
• GIRCIGO: collaborator
• CR2TI-U1064: collaborator
• HEPATIM-GO network: collaborator
• CIC IMAD: collaborator

Study Sites (1)

CHU Nantes

Nantes, France

Location

Central Study Contacts

Jérôme GOURNAY, MD

CONTACT

+33 2.40.08.31.52; Jerome.gournay@chu-nantes.fr

Study Design

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

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2038
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)