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NCT03695796Completed

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

Source: ClinicalTrials.gov · Last updated 24 Sept 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
1005 (actual)
First submitted
2 Oct 2018
Start date
22 Nov 2018
Primary completion date
5 Jun 2025
Lead sponsor
University Hospital, Angers
NCT number
NCT03695796

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1005
  • From 22 Nov 2018 to the primary completion date, 5 Jun 2025
  • 16 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Steatogenic treatment (corticosteroids, tamoxifen, amiodarone, methotrexate)
  • Any evidence of other concomitant chronic liver disease

Other illness

  • Chronic infection with hepatitis B or C
  • Decompensated cirrhosis (ascites, digestive bleeding due to varicose vein rupture, liver failure, hepatocellular failure, hepato-renal syndrome)

Other

  • Excessive alcohol consumption in the last 5 years (\> 210 g / week for men or \> 140 g / week for women)
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Amiens University Hospital
Coordinator of this site? Confirm its status		AmiensFranceUnknown status
University hospital of Besançon
Coordinator of this site? Confirm its status		BesançonFranceUnknown status
University Hospital Of Clermont-Ferrand
Coordinator of this site? Confirm its status		Clermont-FerrandFranceUnknown status
Grenoble University Hospital
Coordinator of this site? Confirm its status		GrenobleFranceUnknown status
Hospital of Le Havre
Coordinator of this site? Confirm its status		Le HavreFranceUnknown status
University Hospital of Lille
Coordinator of this site? Confirm its status		LilleFranceUnknown status
Hospital Center Of Lorient
Coordinator of this site? Confirm its status		LorientFranceUnknown status
Edouard Herriot Hospital
Coordinator of this site? Confirm its status		LyonFranceUnknown status
Saint-Joseph Hospital
Coordinator of this site? Confirm its status		MarseilleFranceUnknown status
University Hospital of NICE
Coordinator of this site? Confirm its status		NiceFranceUnknown status
University of Bordeaux
Coordinator of this site? Confirm its status		PessacFranceUnknown status
University hospital of Rouen
Coordinator of this site? Confirm its status		RouenFranceUnknown status
University Hospital of Strasbourd
Coordinator of this site? Confirm its status		StrasbourgFranceUnknown status
University Hospital of Toulouse
Coordinator of this site? Confirm its status		ToulouseFranceUnknown status
University Hospital of Nancy
Coordinator of this site? Confirm its status		Vandœuvre-lès-NancyFranceUnknown status
University Hospital of Pointe à Pitre
Coordinator of this site? Confirm its status		Pointe-à-PitreGuadeloupeUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.