search
Back to results

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

Primary Purpose

NAFLD

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for NAFLD focused on measuring patients with a NAFLD proven by liver biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Single arm

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 2, 2018
    Last Updated
    October 2, 2018
    Sponsor
    University Hospital, Angers
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03695796
    Brief Title
    French Cohort for the Study of Non-invasive Tests of Liver Lesions in NAFLD/NASH (FreSH Cohort)
    Acronym
    FreSH
    Official Title
    French Cohort for the Study of Non-invasive Tests of Liver Lesions in NAFLD/NASH (FreSH Cohort)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2018 (Anticipated)
    Primary Completion Date
    October 2021 (Anticipated)
    Study Completion Date
    October 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Angers

    4. Oversight

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

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NAFLD
    Keywords
    patients with a NAFLD proven by liver biopsy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    biopsy-proven NAFLD patients
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single arm
    Arm Type
    Other
    Arm Description
    Only one arm because diagnostic study evaluating non-invasive tests using liver biopsy as reference
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank
    Intervention Description
    To evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD and to develop the non-invasive diagnosis of NASH
    Primary Outcome Measure Information:
    Title
    Advanced fibrosis in NAFLD
    Description
    Advanced fibrosis defined by a stage of fibrosis F≥ 3 on liver biopsy according to the semi-quantitative histological classification of NASH CRN
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Non alcoholic steatohepatitis
    Description
    On liver biopsy (NASH CRN classification): steatosis >=1 AND ballooning >=1 AND lobular inflammation >= 1
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jérôme BOURSIER, MD-PHD
    Phone
    +33241353410
    Email
    jeboursier@chu-angers.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandra GIRRE
    Phone
    +33241356053
    Email
    sagirre@chu-angers.fr

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs