Clinical trial NCT04925362: THE FRENCH NATIONAL NAFLD COHORT (FRench pAtients With MEtabolic Steatosis)
Official title: Identification of Clinical and Biological Factors Determining Disease Severity and Disease Progression in NAFLD: "THE FRENCH NATIONAL NAFLD COHORT" FRAMES (FRench pAtients With MEtabolic Steatosis)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: NAFLD
NASH
NASH - Nonalcoholic Steatohepatitis
Fibrosis
Cirrhosis
Keywords: Cohort
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Disease severity
timeFrame: Change of the fibrosis stage from baseline to 10 years
Secondary outcomes:
measure: Ballooning grade
timeFrame: At baseline
measure: Lobular inflammation
timeFrame: At baseline
measure: Steatohepatitis
timeFrame: At baseline
measure: Cirrhosis
timeFrame: Through study completion, an average of 10 years
measure: Obesity
timeFrame: Change from baseline to 10 years
measure: Type 2 diabetes
timeFrame: Change from baseline to 10 years
measure: Dyslipidaemia
timeFrame: Change from baseline to 10 years
measure: Cardiovascular disease
timeFrame: Change from baseline to 10 years
measure: Necroinflammation measured by the activities component of the SAF
timeFrame: Change from baseline to 10 years
measure: Necroinflammation measured by the NAS score
timeFrame: Change from baseline to 10 years
measure: Fasting insulin
timeFrame: Change from baseline to 10 years
measure: Insulin sensitivity
timeFrame: Change from baseline to 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Vlad RATZIU
role: PRINCIPAL_INVESTIGATOR
References: