Actively Recruiting
Characterization of the Intrahepatic Inflammatory Microenvironment in Patients With Non-alcoholic Steatohepatitis by Transcriptomics, Immunophenotyping and Functional Proteomics: Profil-NASH
Led by Hospices Civils de Lyon · Updated on 2025-09-18
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-alcoholic fatty liver disease (NAFLD) includes non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH). NASH differs from NAFL by having liver inflammation and carries risks of progressing to cirrhosis and liver cancer. This condition affects about 25% of adults worldwide, with around 25% of NAFLD patients having NASH. Identifying NASH patients is important for monitoring liver damage and access to treatment trials, but human studies on liver inflammation in NASH are limited. This study involves patients undergoing routine liver biopsy to also receive fine-needle aspiration (FNA) and blood sampling to gather liver and immune cells. Forty patients will participate, with about 75% expected to have NASH and 25% NAFL. Researchers will analyze inflammatory cells using advanced techniques like RNA sequencing and immunophenotyping. Blood cells and circulating microRNAs will also be studied to understand immune regulation. Participants will undergo FNA and blood collection at the time of their liver biopsy, with clinical data recorded electronically. They will be monitored after the procedure as per standard care, with no additional follow-up required by the study. The main outcomes compare inflammatory cell profiles and molecular data between NAFL and NASH patients, plus analysis related to liver fibrosis severity, to better understand inflammation's role in disease progression.
CONDITIONS
Brief Title
Characterization of the Intrahepatic Inflammatory Microenvironment in Patients With Non-alcoholic Steatohepatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with a clinical diagnosis of NAFLD confirmed by imaging and exclusion of secondary causes of steatosis
- Presence of significant liver fibrosis (stage F2 or higher) confirmed by at least one non-invasive test
- Age 18 years or older
- Willingness to undergo liver biopsy
- Ability to provide written informed consent
- Affiliation to a social security scheme
You will not qualify if you...
- Decompensated cirrhosis or clinically significant portal hypertension
- Secondary causes of steatosis such as chronic viral hepatitis, certain drugs, or excessive alcohol consumption (>30 g/day in men, >20 g/day in women)
- Other liver diseases including genetic hemochromatosis or autoimmune liver disease
- Presence of hepatocellular carcinoma at inclusion
- Contraindications to liver biopsy or fine-needle aspiration (coagulation disorders, biliary tract dilation, intrahepatic tumor)
- Pregnant, breastfeeding, or parturient women
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection such as guardianship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment including clinical evaluation
Duration - 1 day
Participants undergo liver biopsy as part of routine medical management. At the same time, fine-needle aspiration and blood sampling are performed to collect samples for detailed analysis.
1 visit (in-person) at Day Hospital including liver biopsy, fine-needle aspiration, and blood sampling
Duration - Duration as per usual care protocol
Participants are monitored following the procedures as part of usual care with no additional follow-up required by the study.
Approximately 1 post-procedure monitoring visit
Trial Site Locations
Total: 1 location
1
Service Hepato Gastrologie
Lyon, Auvergne-Rhône-Alpes, France, 69004
Actively Recruiting
Research Team
Y
Yasmina CHOUIK, MD
M
Marjorie VIALLON, CRA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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