THE FRENCH NATIONAL NAFLD COHORT (FRench pAtients With MEtabolic Steatosis)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Patients with a confirmed diagnosis of NAFLD
Patients affiliated to French social security
Written informed consent signed by the patient
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Biological specimens
Other interventionBiological 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
Other interventionVisits 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)
Treatment groups
900 Participants
are divided into 1 treatment groupGroup A: PatientsOther 2 interventions
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
Ballooning grade
Time frame
At baseline2
Lobular inflammation
Composite scores of Lobular inflammation (Ballooning and Inflammation)
Time frame
At baseline3
Steatohepatitis
Presence or Absence
Time frame
At baseline4
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 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: