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

• ClinicalTrials.gov Identifier: NCT03695796
• Recruitment Status: Unknown
• First Posted: October 4, 2018
• Last Update Posted: October 4, 2018
• Sponsor: University Hospital, Angers
• Information provided by (Responsible Party): University Hospital, Angers

Study Description

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

Condition or disease	Intervention/treatment	Phase
NAFLD	Diagnostic Test: biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: biopsy-proven NAFLD patients
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: French Cohort for the Study of Non-invasive Tests of Liver Lesions in NAFLD/NASH (FreSH Cohort)
• Estimated Study Start Date: October 2018
• Estimated Primary Completion Date: October 2021
• Estimated Study Completion Date: October 2021

Arms and Interventions

Arm	Intervention/treatment
Single arm; 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; To evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD and to develop the non-invasive diagnosis of NASH

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Jérôme BOURSIER, MD-PHD; +33241353410; jeboursier@chu-angers.fr

Contact: Sandra GIRRE; +33241356053; sagirre@chu-angers.fr

Sponsors and Collaborators

University Hospital, Angers

More Information

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT03695796
• Other Study ID Numbers: 49RC18-0076
• First Posted: October 4, 2018
• Last Update Posted: October 4, 2018
• Last Verified: October 2018

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

Keywords provided by University Hospital, Angers:

patients with a NAFLD proven by liver biopsy

Additional relevant MeSH terms:

Non-alcoholic Fatty Liver Disease; Fatty Liver; Liver Diseases; Digestive System Diseases