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

NCT03695796 | Completed

• 1 other identifier: 49RC18_0076
• Study Type: interventional
• Target: 1,005
• Locations: 2 countries
• Sites: 16

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

Conditions

NAFLD

Keywords

patients with a NAFLD proven by liver biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Non alcoholic steatohepatitis

  1 day

• Validate the diagnostic performance and thresholds of 2nd generation blood tests compared to 1st generation blood tests

  1 day

• Validate the diagnostic performance and thresholds of new elastography devices for the assessment of hepatic fibrosis and steatosis

  1 day

• Validate the reliability criteria for Fibroscan in NAFLD, in particular for the XL probe

  1 day

• Defining reliability criteria for Acoustic Radiation Force Impulse and Supersonic Shearwave Imaging in NAFLD

  1 day

Study Arms (1)

Single arm

OTHER

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

Diagnostic Test: biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank

Interventions

biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank DIAGNOSTIC_TEST

To evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD and to develop the non-invasive diagnosis of NASH

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (16)

Amiens University Hospital

Amiens, France

Location

University Hospital of Besançon

Besançon, France

Location

University Hospital of Clermont-Ferrand

Clermont-Ferrand, France

Location

Grenoble University Hospital

Grenoble, France

Location

Hospital of Le Havre

Le Havre, France

Location

University Hospital of Lille

Lille, France

Location

Hospital Center Of Lorient

Lorient, France

Location

Edouard Herriot Hospital

Lyon, France

Location

Saint-Joseph Hospital

Marseille, France

Location

University Hospital Of Nice

Nice, France

Location

University of Bordeaux

Pessac, France

Location

University Hospital of Rouen

Rouen, France

Location

University Hospital of Strasbourd

Strasbourg, France

Location

University Hospital of Toulouse

Toulouse, France

Location

University Hospital Of Nancy

Vandœuvre-lès-Nancy, France

Location

University Hospital of Pointe à Pitre

Pointe-à-Pitre, Guadeloupe

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: biopsy-proven NAFLD patients

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: November 22, 2018
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1); FR (15)