THE FRENCH NATIONAL NAFLD COHORT (FRench pAtients With MEtabolic Steatosis)

N/ANot Yet RecruitingNCT04925362

Assistance Publique - Hôpitaux de Paris900 enrolled

Overview

The main objective of this cohort study is to determine genetic, clinical biologic and metabolic factors associated with patient heterogeneity in regards to severity of NAFLD at diagnosis as well as during the clinical course. * at diagnosis, with the aim to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis * during the clinical course to better understand and predict disease progression in terms notably of fibrosis progression and progression to cirrhosis

Non-alcoholic fatty liver disease (NAFLD) is considered the hepatic manifestation of metabolic syndrome and is currently the most common cause of liver disease in many developed countries worldwide. The aim of the study is to improve the scientific knowledge on markers associated with disease severity and progression in NAFLD. The study is a multicentre French NAFLD cohort of well-characterized patients with biological samples covering the entire spectrum of NAFLD severity (steatosis, NASH, significant fibrosis, cirrhosis, hepatocellular carcinoma).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

900

Conditions

NAFLD NASH NASH - Nonalcoholic Steatohepatitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥18 years 2. Patients with a confirmed diagnosis of NAFLD 3. Patients affiliated to French social security 4. Written informed consent signed by the patient Exclusion Criteria: 1. Refusal or inability (lack of capacity) to give informed consent. 2. Average alcohol ingestion greater than 21/14 units/week (males/females) in the preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years. 3. History or presence of Type 1 diabetes mellitus. 4. Presence of any other form of chronic liver disease except NAFLD 5. Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \[\>10 days\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid). 6. Any contra-indication to liver biopsy. 7. Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline. 8. Non-French speaking/unable to access an interpreter. 9. Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. judged by the physician as unlikely to be compliant with the study protocol). 10. Pregnant or breastfeeding women 11. Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom

Outcomes

Primary Outcomes

Disease severity

The disease severity defined by the fibrosis stage on liver biopsy according to the semi-quantitative histological classification of NASH CRN.

Time frame: Change of the fibrosis stage from baseline to 10 years

Secondary Outcomes

Ballooning grade

Time frame: At baseline

Lobular inflammation

Composite scores of Lobular inflammation (Ballooning and Inflammation)

Time frame: At baseline

Steatohepatitis

Presence or Absence

Time frame: At baseline

Cirrhosis

Cirrhosis defined by either : 1. stage 4 of histological classification of fibrosis on liver biopsy or 2. liver stiffness \>14 kPa by elastometry

Time frame: Through study completion, an average of 10 years

Obesity

Obesity defined by either : 1. Increased waist circumference by ethnically adjusted criteria or 2. BMI ≥25