French Cohort for the Study of Non-invasive Tests of Liver Lesions in NAFLD/NASH (FreSH Cohort)

NAFLD Clinical Trial

— FreSH  

Official title:

French Cohort for the Study of Non-invasive Tests of Liver Lesions in NAFLD/NASH (FreSH Cohort)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03695796
• Other study ID #: 49RC18-0076
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2018
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Angers
• Contact: Jérôme BOURSIER, MD-PHD
• Phone: +33241353410
• Email: jeboursier[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2024
• Est. primary completion date: November 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Diagnostic Test:
• biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank
To evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD and to develop the non-invasive diagnosis of NASH

Locations

Country	Name	City	State
France	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	University of Bordeaux	Pessac
France	University Hospital of Pointe à Pitre	Pointe-à-Pitre
France	University Hospital of Rouen	Rouen
France	University Hospital of Strasbourd	Strasbourg
France	University Hospital of Toulouse	Toulouse
France	University Hospital Of Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day
Secondary	Non alcoholic steatohepatitis	On liver biopsy (NASH CRN classification): steatosis >=1 AND ballooning >=1 AND lobular inflammation >= 1	1 day