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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,005
To evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD and to develop the non-invasive diagnosis of NASH
Amiens University Hospital
Amiens, France
University Hospital of Besançon
Besançon, France
University Hospital of Clermont-Ferrand
Clermont-Ferrand, France
Grenoble University Hospital
Grenoble, France
Hospital of Le Havre
Le Havre, France
University Hospital of Lille
Lille, France
Hospital Center Of Lorient
Lorient, France
Edouard Herriot Hospital
Lyon, France
Saint-Joseph Hospital
Marseille, France
University Hospital Of Nice
Nice, France
...and 6 more locations
Advanced fibrosis in NAFLD
Advanced fibrosis defined by a stage of fibrosis F≥ 3 on liver biopsy according to the semi-quantitative histological classification of NASH CRN
Time frame: 1 day
Non alcoholic steatohepatitis
On liver biopsy (NASH CRN classification): steatosis \>=1 AND ballooning \>=1 AND lobular inflammation \>= 1
Time frame: 1 day
Validate the diagnostic performance and thresholds of 2nd generation blood tests compared to 1st generation blood tests
Time frame: 1 day
Validate the diagnostic performance and thresholds of new elastography devices for the assessment of hepatic fibrosis and steatosis
Time frame: 1 day
Validate the reliability criteria for Fibroscan in NAFLD, in particular for the XL probe
Time frame: 1 day
Defining reliability criteria for Acoustic Radiation Force Impulse and Supersonic Shearwave Imaging in NAFLD
Time frame: 1 day
Validating the performance of the eLIFT algorithm for screening advanced liver fibrosis in NAFLD
Time frame: 1 day
Assessing the prognostic value of non-invasive fibrosis tests for predicting death from liver-related causes
Time frame: 1 day
Identify new biomarkers for the non-invasive diagnosis of NASH thanks to collaborations developed by the investigating centres with teams with expertise in 'omics' technologies
Time frame: 1 day
Estimate the correlation between a new serum marker, phosphatydylethanol, and alcohol consumption in patients with non-alcoholic fatty liver disease
Time frame: 1 day
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