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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: NASH; Cirrhosis; NAFLD; Fibrosis; NASH - Nonalcoholic Steatohepatitis

Treatments: Other: Biological specimens; Other: Additional visit

Study type: Interventional

Funder types: Other

Identifiers

NCT04925362

APHP190417

2019-A01308-49 (Other Identifier)

Details and patient eligibility

About

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

Full description

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).

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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900 participants in 1 patient group

Patients

Other group

Description:

Patients with histologically confirmed NAFLD

Treatment:

Other: Biological specimens

Other: Additional visit