Clinical trial NCT03695796: French Cohort for the Study of Non-invasive Tests of Liver Lesions in NAFLD/NASH (FreSH Cohort)
Official title: French Cohort for the Study of Non-invasive Tests of Liver Lesions in NAFLD/NASH (FreSH Cohort)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NAFLD
Keywords: patients with a NAFLD proven by liver biopsy
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-10-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: biopsy-proven NAFLD patients
Primary purpose: DIAGNOSTIC

Brief summary: Currently, the management of non-alcoholic fatty liver disease (NAFLD) patients has two main limitations. First, there is no approved treatment in NAFLD. Second, liver biopsy remains the reference procedure for the evaluation of liver lesions but it is invasive and can't be proposed to all NAFLD patients who represent 25% of the general population. Phase III trials have recently started in NAFLD with the hope of new treatments available in few years on the market. Consequently, we now need to develop and validate the non-invasive tools that will allow the identification of the subset of NAFLD patients who will benefit from treatment with the new drugs once they will be available in clinical practice.

We aim to generate of large multicenter cohort of biopsy-proven NAFLD patients including non-invasive tests of liver lesions (blood tests, elastography devices) and a biobank to promote a research network in the field of non-invasive diagnosis of liver lesions in NAFLD. Eight French centers highly experienced in this field of research will participate to the cohort.

Our primary aim will be to evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD. The primary endpoint will be advanced fibrosis as defined by fibrosis stages F3/4 by the NASH-CRN histological semi-quantitative scoring


Eligibility criteria: Inclusion Criteria:

* NAFLD diagnosis defined by the presence of at least two of the following elements:

  * Liver steatosis (hyperechoic liver on hepatic ultrasound, quantification \> 5.6 % by spectroscopy or MRI)
  * Presence of one metabolic risk factor:

    * BMI ≥ 25 kg/m2 or waist circumference ≥ 94 cm (male) / ≥ 80 cm (female)
    * Antihypertensive treatment or systolic BP ≥ 130 mmHg or diastolic BP ≥ 85 mmHg
    * Antidiabetic treatment or fasting blood glucose ≥ 5.6 mmol/l
    * Lipid-lowering treatment or triglycerides ≥ 1.71 mmol/l or HDL cholesterol \<1.1 mmol/l (male) / \<1.3 mmol/l (female)
    * Dysmetabolic hyperferritinemia
  * Anomaly in the liver enzyme test or liver function tests
* Indication for liver biopsy in the clinical management of the patient
* Obtaining the signature of the consent to participate in the study

Exclusion Criteria:

* Steatogenic treatment (corticosteroids, tamoxifen, amiodarone, methotrexate)
* Excessive alcohol consumption in the last 5 years (\> 210 g / week for men or \> 140 g / week for women)
* Chronic infection with hepatitis B or C
* Any evidence of other concomitant chronic liver disease
* Decompensated cirrhosis (ascites, digestive bleeding due to varicose vein rupture, liver failure, hepatocellular failure, hepato-renal syndrome)
* Hepatocellular carcinoma
* Pregnant, breastfeeding or parturient women
* Persons deprived of their liberty by judicial or administrative decision
* Persons subject to legal protection measures
* Persons unable to consent
* Refusal to participate

Primary outcomes:
measure: Advanced fibrosis in NAFLD
timeFrame: 1 day
Secondary outcomes:
measure: Non alcoholic steatohepatitis
timeFrame: 1 day
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
city: Besançon
country: France
facility: University Hospital of Besançon
city: Clermont-Ferrand
country: France
facility: University Hospital of Clermont-Ferrand
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Le Havre
country: France
facility: Hospital of Le Havre
city: Lille
country: France
facility: University Hospital of Lille
city: Lorient
country: France
facility: Hospital Center Of Lorient
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Marseille
country: France
facility: Saint-Joseph Hospital
city: Nice
country: France
facility: University Hospital Of Nice
city: Pessac
country: France
facility: University of Bordeaux
city: Pointe-à-Pitre
country: France
facility: University Hospital of Pointe à Pitre
city: Rouen
country: France
facility: University Hospital of Rouen
city: Strasbourg
country: France
facility: University Hospital of Strasbourd
city: Toulouse
country: France
facility: University Hospital of Toulouse
city: Vandœuvre-lès-Nancy
country: France
facility: University Hospital Of Nancy
Study officials:
References: