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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

October 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Advanced fibrosis in NAFLD[ Time Frame: 1 day ]

Advanced fibrosis defined by a stage of fibrosis F≥ 3 on liver biopsy according to the semi-quantitative histological classification of NASH CRN

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Non alcoholic steatohepatitis[ Time Frame: 1 day ]
On liver biopsy (NASH CRN classification): steatosis >=1 AND ballooning >=1 AND lobular inflammation >= 1

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description: biopsy-proven NAFLD patients
Masking: Interventional
Masking Description:
Primary Purpose: Diagnostic

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Other: Single arm
Only one arm because diagnostic study evaluating non-invasive tests using liver biopsy as reference

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1000

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2021

Estimated Primary Completion Date

October 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University Hospital, Angers

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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