THE FRENCH NATIONAL NAFLD COHORT (FRench pAtients With MEtabolic Steatosis)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological specimens, Additional visit.
- Who it may be relevant to
- Registry conditions: NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
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
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).
Interventions
- Other 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) - 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)
Primary outcome measures
- Disease severity [Time frame: Change of the fibrosis stage from baseline to 10 years]
Secondary outcome measures (12)
- Ballooning grade [Time frame: At baseline]
- Lobular inflammation [Time frame: At baseline]
- Steatohepatitis [Time frame: At baseline]
- Cirrhosis [Time frame: Through study completion, an average of 10 years]
- Obesity [Time frame: Change from baseline to 10 years]
- Type 2 diabetes [Time frame: Change from baseline to 10 years]
- Dyslipidaemia [Time frame: Change from baseline to 10 years]
- Cardiovascular disease [Time frame: Change from baseline to 10 years]
- Necroinflammation measured by the activities component of the SAF [Time frame: Change from baseline to 10 years]
- Necroinflammation measured by the NAS score [Time frame: Change from baseline to 10 years]
- Fasting insulin [Time frame: Change from baseline to 10 years]
- Insulin sensitivity [Time frame: Change from baseline to 10 years]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Patients with a confirmed diagnosis of NAFLD
- Patients affiliated to French social security
- Written informed consent signed by the patient
Exclusion criteria
- Refusal or inability (lack of capacity) to give informed consent.
- 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.
- History or presence of Type 1 diabetes mellitus.
- Presence of any other form of chronic liver disease except NAFLD
- 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).
- Any contra-indication to liver biopsy.
- 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.
- Non-French speaking/unable to access an interpreter.
- 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).
- Pregnant or breastfeeding women
- Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04925362 · APHP190417 · 2019-A01308-49