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

NCT ID: NCT04925362

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2036-06-30

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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients

Patients with histologically confirmed NAFLD

Group Type: OTHER

Biological specimens

Intervention Type: OTHER

Biological specimens are collected to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis :

• added for the research : blood, urine, stools
• collected for the research : liver tissue sample, if a liver biopsy is indicated for clinical reasons (standard of care)

Additional visit

Intervention Type: OTHER

Visits if possible during standard care, otherwise added by the research (If necessary the annual visit will be added by research for the collection of biological samples)

Interventions

Biological specimens

Biological specimens are collected to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis :

• added for the research : blood, urine, stools
• collected for the research : liver tissue sample, if a liver biopsy is indicated for clinical reasons (standard of care)

Intervention Type: OTHER

Additional visit

Visits if possible during standard care, otherwise added by the research (If necessary the annual visit will be added by research for the collection of biological samples)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vlad RATZIU

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Central Contacts

Vlad RATZIU

Role: CONTACT

vlad.ratziu@aphp.fr

0142161001 ext. +33

Other Identifiers

2019-A01308-49

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190417

Identifier Type: -

Identifier Source: org_study_id