<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04435054</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0033</org_study_id>
    <nct_id>NCT04435054</nct_id>
  </id_info>
  <brief_title>Screening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology.</brief_title>
  <acronym>NAFLD-CARE</acronym>
  <official_title>Screening for NAFLD-related Advanced Fibrosis in High Risk popuLation: Optimization of the Diabetology Pathway Referral Using Combinations of Non-invAsive Biological and elastogRaphy paramEters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nonalcoholic fatty liver disease (NAFLD) is being recognized as one of the most prevalent&#xD;
      causes of chronic liver disease worldwide. The current strategy proposed by the&#xD;
      EASL/EASO/EASD European guidelines for the screening of nonalcoholic fatty liver disease&#xD;
      (NAFLD) in high-risk population such as type 2 diabetes and patients with obesity leads to an&#xD;
      over-referral in hepatology clinics. The proposed study will investigate the optimal strategy&#xD;
      for the screening of NAFLD-related advanced fibrosis in patients at high risk of fibrotic&#xD;
      NAFLD, such as patients with T2DM or obesity by maximizing the positive predictive value&#xD;
      (PPV) using non-invasive blood and elastography-based biomarkers in endocrinology/diabetology&#xD;
      clinics in order to reduce the over-referral to hepatology clinics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 28, 2020</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of individual F0 to F4 stage of fibrosis</measure>
    <time_frame>6 months</time_frame>
    <description>The presence of individual F0 to F4 stage of fibrosis as defined by histological stage in the liver biopsy using the NASH CRN Scoring System.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fibroscan</measure>
    <time_frame>6 months</time_frame>
    <description>The presence of liver stiffness measured using Fibroscan (VCTE) ≥ 7 kPa.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Non-Alcoholic Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>Non invasive tests</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.</intervention_name>
    <description>Non-invasive blood biological tests - NAFLD Fibrosis Score, FIB-4, Fibrotest, FibrometerNAFLD&#xD;
Non-invasive imaging:&#xD;
- Transient elastography (FibroScan), Shear Wave imaging, Magnetic resonance imaging (MRI-PDFF and MRE) in a subgroup of participants.</description>
    <arm_group_label>Non invasive tests</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged between 40 and 80 years old,&#xD;
&#xD;
          -  Patients with diagnosis of T2DM* or obesity (defined according to World Health&#xD;
             Organization as a BMI≥ 30 kg/m2)&#xD;
&#xD;
          -  Patient with hepatic steatosis determined by conventional abdominal ultrasound as&#xD;
             defined by the EASL/EASO/EASD European guidelines.&#xD;
&#xD;
          -  Patient who agrees to be included in the study and who signs the informed consent&#xD;
             form,&#xD;
&#xD;
          -  Patient affiliated to a healthcare insurance plan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of other causes of chronic liver disease:&#xD;
&#xD;
          -  History of ingestion of medications known to produce steatosis in the previous 6&#xD;
             months.&#xD;
&#xD;
          -  Evidence of cirrhosis or previously known cirrhosis based on the results from previous&#xD;
             liver biopsy or history of portal hypertension presented by ascites, hepatic&#xD;
             encephalopathy or varices&#xD;
&#xD;
          -  Presence of regular and/or excessive use of alcohol (defined as &gt;30g/day for males and&#xD;
             &gt;15g/day for females) for a period longer than 2 years at any times in the last 10&#xD;
             years&#xD;
&#xD;
          -  The subject is a pregnant or nursing female&#xD;
&#xD;
          -  Life expectancy less than 5 years&#xD;
&#xD;
          -  History of known HIV infection&#xD;
&#xD;
          -  History of type 1 diabete&#xD;
&#xD;
          -  BMI ≥ 40 kg/m2&#xD;
&#xD;
          -  Mentally unbalanced patients, under supervision or guardianship,&#xD;
&#xD;
          -  Patient deprived of liberty,&#xD;
&#xD;
          -  Patient who does not understand French/ is unable to give consent,&#xD;
&#xD;
          -  Patient already included in a trial who may interfere with the study or in a period of&#xD;
             exclusion following participation in a previous study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cyrielle CAUSSY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cyrielle CAUSSY, MD</last_name>
    <phone>04 78 86 44 48</phone>
    <phone_ext>+33</phone_ext>
    <email>cyrielle.caussy@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dominique DELAUNAY</last_name>
    <phone>04.72.11.00.64</phone>
    <phone_ext>+33</phone_ext>
    <email>Dominique.delaunay@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Bruno Verges, MD, PhD</last_name>
      <phone>03 80 74 08 05</phone>
      <phone_ext>+33</phone_ext>
      <email>bruno.verges@chu-dijon.fr</email>
    </contact>
    <investigator>
      <last_name>Bruno Verges, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Bertrand Cariou, MD, PhD</last_name>
      <phone>02 40 08 33 33</phone>
      <phone_ext>+33</phone_ext>
      <email>bertrand.cariou@univ-nantes.fr</email>
    </contact>
    <investigator>
      <last_name>Bertrand Cariou, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cyrielle CAUSSY, MD, PhD</last_name>
      <phone>04 78 86 44 48</phone>
      <phone_ext>+33</phone_ext>
      <email>cyrielle.caussy@chu-lyon.fr</email>
    </contact>
    <contact_backup>
      <last_name>Dominique DELAUNAY</last_name>
      <phone>04.72.11.00.64</phone>
      <phone_ext>+33</phone_ext>
      <email>Dominique.delaunay@chu-lyon.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Cyrielle CAUSSY, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NAFLD</keyword>
  <keyword>Type 2 diabete</keyword>
  <keyword>Obesity</keyword>
  <keyword>Advanced fibrosis</keyword>
  <keyword>Cirrhosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04435054
org study id: 69HCL20_0033
nct id: NCT04435054
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Nonalcoholic fatty liver disease (NAFLD) is being recognized as one of the most prevalent
      causes of chronic liver disease worldwide. The current strategy proposed by the
      EASL/EASO/EASD European guidelines for the screening of nonalcoholic fatty liver disease
      (NAFLD) in high-risk population such as type 2 diabetes and patients with obesity leads to an
      over-referral in hepatology clinics. The proposed study will investigate the optimal strategy
      for the screening of NAFLD-related advanced fibrosis in patients at high risk of fibrotic
      NAFLD, such as patients with T2DM or obesity by maximizing the positive predictive value
      (PPV) using non-invasive blood and elastography-based biomarkers in endocrinology/diabetology
      clinics in order to reduce the over-referral to hepatology clinics.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Presence of individual F0 to F4 stage of fibrosis
time frame: 6 months
description: The presence of individual F0 to F4 stage of fibrosis as defined by histological stage in the liver biopsy using the NASH CRN Scoring System.
measure: Fibroscan
time frame: 6 months
description: The presence of liver stiffness measured using Fibroscan (VCTE) ≥ 7 kPa.
arm group label: Non invasive tests
arm group type: Other
intervention type: Diagnostic Test
intervention name: Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.
description: Non-invasive blood biological tests - NAFLD Fibrosis Score, FIB-4, Fibrotest, FibrometerNAFLD
Non-invasive imaging:
- Transient elastography (FibroScan), Shear Wave imaging, Magnetic resonance imaging (MRI-PDFF and MRE) in a subgroup of participants.
arm group label: Non invasive tests
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Cyrielle CAUSSY, MD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
last name: Cyrielle CAUSSY, MD
phone: 04 78 86 44 48
phone ext: +33
email: cyrielle.caussy@chu-lyon.fr
last name: Dominique DELAUNAY
phone: 04.72.11.00.64
phone ext: +33
email: Dominique.delaunay@chu-lyon.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Fibrosis