<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/NCT04442334</url>
  </required_header>
  <id_info>
    <org_study_id>08759</org_study_id>
    <secondary_id>634413</secondary_id>
    <secondary_id>777377</secondary_id>
    <nct_id>NCT04442334</nct_id>
  </id_info>
  <brief_title>The European NAFLD Registry</brief_title>
  <official_title>The European NAFLD Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Newcastle-upon-Tyne Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Cardiometabolism and Nutrition, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cambridge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Örebro University, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Angers</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Helsinki</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National and Kapodistrian University of Athens</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Lisbon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Milan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Palermo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuerzburg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RWTH Aachen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Florence</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Medical Center Mainz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Newcastle University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The European NAFLD Registry is a prospectively recruited, observational study supporting the&#xD;
      study of the clinical phenotype, natural history, disease outcomes and pathophysiology of&#xD;
      Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are&#xD;
      to better understand the drivers of interpatient variation in disease pathophysiology and&#xD;
      severity and to utilise this information to develop and validate biomarkers that, singly or&#xD;
      in combination, enable detection and monitoring of disease progression and/or from NAFL&#xD;
      through NASH to fibrosis and cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The European NAFLD Registry is a major international collaboration between clinical academics&#xD;
      at leading universities across Europe, initially established with funding from the European&#xD;
      Association for the Study of the Liver and through the EU FP7, H2020 and IMI2 schemes to the&#xD;
      projects FLIP (Fatty Liver Inhibition of Progression), EPoS (Elucidating Pathways of&#xD;
      Steatohepatitis) and LITMUS (Liver Investigation: Testing marker Utility in Steatohepatitis).&#xD;
&#xD;
      The Registry is a non-interventional, observational study collecting cross-sectional and&#xD;
      longitudinal clinical data (including clinical biochemistry/haematology, liver histology,&#xD;
      comorbidities, prescribed medication and imaging data) and linked biological samples (Blood&#xD;
      [Serum, Plasma], Liver Tissue, Urine, Stool) from prospectively recruited patients with&#xD;
      NAFLD. Its purpose is to support clinical and translational research into disease&#xD;
      pathophysiology (through development of comprehensive genetic, epigenetic, transcriptomic,&#xD;
      metabolomic, proteomic and metagenomic datasets) and biomarker development/validation. It&#xD;
      supports collaborative discovery science and serves as the basis for a broad international&#xD;
      project to discover and validate biomarkers for NAFLD and associated medical conditions&#xD;
      (LITMUS). Out-with the current study, following separate ethical approval and after separate&#xD;
      consent, patients who have agreed to join the European NAFLD Registry may also agree to&#xD;
      participate in a number of nested sub-studies with bi-directional sharing of data. These&#xD;
      include the LITMUS Imaging Study, which will acquire additional imaging data across a range&#xD;
      of modalities including, amongst others, MR-PDFF and MR-Elastography. The Registry population&#xD;
      comprises adult patients (aged ≥18 years) with risk factors for non-alcoholic fatty liver&#xD;
      disease (NAFLD) prospectively recruited primarily in hepatology and diabetology clinics&#xD;
      and/or bariatric surgery units at centres across Europe. After receiving informed consent,&#xD;
      patients will be assigned a unique study identifier (which will be used to identify all data&#xD;
      and samples collected) which will allow all information to be recorded in a link-anonymised&#xD;
      form.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2030</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Detailed Characterisation of the NAFLD Patient Phenotype</measure>
    <time_frame>1 day</time_frame>
    <description>Prospective patient recruitment and collection of cross-sectional clinical data is undertaken (including clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data).These data will be used to determine number of participants exhibiting specific features of NAFLD/NASH disease severity at enrolment including: histological grade of disease and fibrosis stage (assessed using the well validated NASH Clinical Research Network &quot;NAFLD Activity Score&quot; [NAS] and the FLIP &quot;Steatosis - Activity - Fibrosis&quot; [SAF] systems), frequency of common metabolic comorbidities (eg type 2 diabetes mellitus, dyslipidaemia, cardiovascular disease), and associated changes in clinical biochemistry/haematology/imaging parameters. Biological samples to support clinical and translational research into disease pathophysiology (e.g. genetic, epigenetic, transcriptomic, metabolomic, proteomic and metagenomic datasets) and biomarker development/validation will be collected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Natural History</measure>
    <time_frame>Through to study completion, an average of 5 years</time_frame>
    <description>Longitudinal follow-up of patients with NAFLD by annual review to characterise disease natural history and determine number of participants experiencing clinically significant events including the occurrence and timing of incident comorbidities and key target conditions of interest such as:&#xD;
Death (cause of death)&#xD;
Major Adverse Cardiovascular Events (MACE)&#xD;
Hepatic (e.g. diagnosis of cirrhosis, hepatic decompensation, hepatocellular carcinoma, transplantation)&#xD;
Other (diagnosis of extra-hepatic malignancy/emergency hospitalisation)&#xD;
Routine clinical data generated as part of standard care will be collected annually. Clinical parameters assessed for changes indicative of alteration in disease state during follow-up include: clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data. Biological samples to support translational research into disease pathophysiology and biomarker development/validation will also be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifestyle factors: Dietary Habits</measure>
    <time_frame>Through study completion, an average of 5 years</time_frame>
    <description>Cross-sectional and longitudinal study of dietary habits in patients with NAFLD using: Mediterranean Diet Score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifestyle factors: Activity/Exercise</measure>
    <time_frame>Through study completion, an average of 5 years</time_frame>
    <description>Cross-sectional and longitudinal study of lifestyle factors (e.g. activity/sedentary behaviour/exercise levels) in patients with NAFLD using: International Physical Activity Questionnaire (IPAQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life: CLDQ</measure>
    <time_frame>Through study completion, an average of 5 years</time_frame>
    <description>Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): Chronic Liver Disease Questionnaire for NAFLD NASH (CLDQ NAFLD-NASH).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life: EQ5D5L</measure>
    <time_frame>Through study completion, an average of 5 years</time_frame>
    <description>Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): EQ-5D-5L Health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life: NASH-CHECK</measure>
    <time_frame>Through study completion, an average of 5 years</time_frame>
    <description>Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): NASH-CHECK.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>NAFLD</condition>
  <condition>NASH</condition>
  <condition>NASH - Nonalcoholic Steatohepatitis</condition>
  <condition>Fibrosis, Liver</condition>
  <condition>Steatosis of Liver</condition>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Type 2 Diabetes</condition>
  <condition>Dyslipidaemia</condition>
  <condition>Hypertension</condition>
  <condition>Obesity</condition>
  <condition>Other Associated Comorbidities</condition>
  <arm_group>
    <arm_group_label>The LITMUS Study Cohort</arm_group_label>
    <description>Prospectively recruited NAFLD patients, recruited according to The European NAFLD Registry study protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The LITMUS Metacohort</arm_group_label>
    <description>Collated data and biological samples on patients with histologically characterised NAFLD prospectively recruited at contributing academic centres across Europe.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EFPIA Clinical Trial Cohort</arm_group_label>
    <description>Collated data and biological samples on patients with histologically characterised NAFLD that have participated in phase 2 and phase 3 trials of IMPs for NAFLD.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood (serum, plasma, whole blood, DNA, RNA), Liver tissue, Urine, stool, DNA, RNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with a pre-existing liver biopsy providing histological evidence of NAFLD&#xD;
        or, patients undergoing liver biopsy for suspected NAFLD with biochemical and/or&#xD;
        radiological findings consistent with NAFLD, or patients with radiological evidence of&#xD;
        cirrhosis (in absence of an alternative aetiology) plus presence of ≥2 features indicative&#xD;
        of the 'metabolic syndrome'.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years.&#xD;
&#xD;
          2. Clinically suspected NAFLD based on any of:&#xD;
&#xD;
               1. Patient with historical liver biopsy providing histological evidence of NAFLD or,&#xD;
&#xD;
               2. Patient undergoing liver biopsy for suspected NAFLD with biochemical and/or&#xD;
                  radiological findings consistent with NAFLD or,&#xD;
&#xD;
               3. Patient with radiological evidence of cirrhosis (in absence of an alternative&#xD;
                  aetiology) plus presence of ≥2 features indicative of the 'metabolic syndrome':&#xD;
&#xD;
                    -  Increased waist circumference by ethnically adjusted criteria (e.g. Europid&#xD;
                       male/female ≥94cm/80cm) or overweight/obese (BMI ≥25);&#xD;
&#xD;
                    -  Raised fasting glucose ≥100 mg/dL [5.6 mmol/L], HbA1c ≥48mmol/mol (6.5%) or&#xD;
                       previously diagnosed insulin resistance/type 2 diabetes mellitus (or on&#xD;
                       treatment);&#xD;
&#xD;
                    -  Dyslipidaemia (fasting TG level ≥150 mg/dL [1.7 mmol/L]; or fasting HDL &lt;40&#xD;
                       mg/dL [1.03 mmol/L] in males and &lt;50 mg/dL [1.29 mmol/L] in females; or on&#xD;
                       treatment);&#xD;
&#xD;
                    -  Hypertension (systolic BP ≥130 or diastolic BP ≥85 mmHg, or on treatment).&#xD;
&#xD;
          3. Average alcohol consumption less than 21/14 units/week (males/females) in preceding 6&#xD;
             months and no history of sustained excessive consumption of alcohol in past 5 years.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Refusal or inability (lack of capacity) to give informed consent.&#xD;
&#xD;
          2. Average alcohol ingestion greater than approximately 21/14 units/week (males/females)&#xD;
             in preceding 6 months or history of sustained excessive consumption of alcohol in past&#xD;
             5 years.&#xD;
&#xD;
          3. History or presence of Type 1 diabetes mellitus.&#xD;
&#xD;
          4. Presence of any other form of chronic liver disease except NAFLD.&#xD;
&#xD;
          5. Recent (within 12 months) or concomitant use of agents known to cause hepatic&#xD;
             steatosis (long-term systemic corticosteroids [&gt;10 days], amiodarone, methotrexate,&#xD;
             tamoxifen, tetracycline, high dose oestrogens, valproic acid).&#xD;
&#xD;
          6. Any contra-indication to liver biopsy.&#xD;
&#xD;
          7. Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a&#xD;
             dose ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or&#xD;
             pentoxifylline.&#xD;
&#xD;
          8. Non-English speaking/unable to access an interpreter. Due to the nature of the study,&#xD;
             English language or access to a relevant interpreter is a necessary criterion to&#xD;
             ensure lifestyle (diet and exercise) and symptom data are collated.&#xD;
&#xD;
          9. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable&#xD;
             for inclusion in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Quentin M Anstee, MBBS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Newcastle University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Quentin M Anstee, MBBS, PhD</last_name>
    <phone>+44(0)191 20 87012</phone>
    <email>quentin.anstee@ncl.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kristy L Wonders, BA, MLitt</last_name>
    <phone>+44(0)191 2083959</phone>
    <email>kristy.wonders@ncl.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen</name>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sven M Francque, MD, PhD</last_name>
      <phone>+3238214572</phone>
      <email>Sven.Francque@uza.be</email>
    </contact>
    <investigator>
      <last_name>Sven M Francque, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hannele Yki-Järvinen, MD</last_name>
      <email>Hannele.Yki-Jarvinen@helsinki.fi</email>
    </contact>
    <investigator>
      <last_name>Hannele Yki-Järvinen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Le Centre de Recherche Clinique (CRC) du CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jerome Boursier, MD, PhD</last_name>
      <email>JeBoursier@chu-angers.fr</email>
    </contact>
    <investigator>
      <last_name>Jerome Boursier, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vlad Ratzu, MD</last_name>
      <email>vlad.ratziu@inserm.fr</email>
    </contact>
    <investigator>
      <last_name>Vlad Ratzu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UNIVERSITÄTSKLINIKUM der RWTH Aachen</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christian Trautwein, MD</last_name>
      <email>ctrautwein@ukaachen.de</email>
    </contact>
    <investigator>
      <last_name>Christian Trautwein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Charité University Hospital Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Muenevver Demir, MD</last_name>
      <email>muenevver.demir@charite.de</email>
    </contact>
    <investigator>
      <last_name>Muenevver Demir, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Rafael Kaeser, DrMed</last_name>
      <phone>+49 761 270-35500</phone>
      <email>rafael.kaeser@uniklinik-freiburg-.de</email>
    </contact>
    <investigator>
      <last_name>Rafael Kaeser, DrMed</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jörn M Schattenberg, DrMed</last_name>
      <phone>+49 (0) 6131 176074</phone>
      <email>joern.schattenberg@unimedizin-mainz.de</email>
    </contact>
    <investigator>
      <last_name>Jörn M Schattenberg, DrMed</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikums Würzburg</name>
      <address>
        <city>Würzburg</city>
        <zip>D-97080</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Geier, MD</last_name>
      <email>Geier_A2@ukw.de</email>
    </contact>
    <investigator>
      <last_name>Andreas Geier, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Laiko General Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gergios Papatheodoridis, MD, PhD</last_name>
      <email>gepapath@med.uoa.gr</email>
    </contact>
    <investigator>
      <last_name>Gergios Papatheodoridis, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Polytechnic University of Marche</name>
      <address>
        <city>Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gianluca Svegliati-Baroni, MD</last_name>
      <email>gsvegliati@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Gianluca Svegliati-Baroni, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Università degli Studi Milano</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luca Valenti, MD</last_name>
      <email>luca.valenti@unimi.it</email>
    </contact>
    <investigator>
      <last_name>Luca Valenti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Università di Palermo</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Salvatore Petta, MD, PhD</last_name>
      <email>petta.salvatore@unipa.it</email>
    </contact>
    <investigator>
      <last_name>Salvatore Petta, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Università Cattolica del Sacro Cuore</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luca Miele, MD, PhD</last_name>
      <email>luca.miele@policlinicogemelli.it</email>
    </contact>
    <investigator>
      <last_name>Luca Miele, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Medical Sciences University of Torino</name>
      <address>
        <city>Turin</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elisabetta Bugianesi, MD, PhD</last_name>
      <email>elisabetta.bugianesi@unito.it</email>
    </contact>
    <investigator>
      <last_name>Elisabetta Bugianesi, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A G Holleboom, MD, PhD</last_name>
      <email>a.g.holleboom@amsterdamumc.nl</email>
    </contact>
    <investigator>
      <last_name>A G Holleboom, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ulrich Beuers, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital de Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Helena Cortez-Pinto, MD, PhD</last_name>
      <email>hlcortezpinto@netcabo.pt</email>
    </contact>
    <investigator>
      <last_name>Helena Cortez-Pinto, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vall d'Hebron University Hospital</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Salva Augustin, MD</last_name>
      <email>salva.augustin@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Salva Augustin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Biodonostia Health Research Institute</name>
      <address>
        <city>Donostia</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jesus Banales, PhD</last_name>
      <email>Jesus.banales@biodonostia.org</email>
    </contact>
    <investigator>
      <last_name>Jesus Banales, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Puerta de Hierro University Hospital</name>
      <address>
        <city>Majadahonda</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joseluis Calleja, MD</last_name>
      <email>Joseluis.calleja@uam.es</email>
    </contact>
    <investigator>
      <last_name>Joseluis Calleja, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marqués de Valdecilla University Hospital</name>
      <address>
        <city>Santander</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Javier Crespo, MD</last_name>
      <email>Javiercrespo1991@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Javier Crespo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manuel Romero-Gomez, MD</last_name>
      <email>mromerogomez@us.es</email>
    </contact>
    <investigator>
      <last_name>Manuel Romero-Gomez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>HU Clínico de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rocío Aller de la Fuente, MD, PhD</last_name>
      <email>rallerf@saludcastillayleon.es</email>
    </contact>
    <investigator>
      <last_name>Rocío Aller de la Fuente, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhuset</name>
      <address>
        <city>Huddinge</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hannes Hagstrom, MD</last_name>
      <email>hannes.hagstrom@ki.se</email>
    </contact>
    <investigator>
      <last_name>Hannes Hagstrom, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Linköping University Hospital</name>
      <address>
        <city>Linköping</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mattias Ekstedt, MD</last_name>
      <email>mattias.ekstedt@liu.se</email>
    </contact>
    <investigator>
      <last_name>Mattias Ekstedt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Inselspital, University Hospital</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Francois Dufour, MD, PhD</last_name>
      <email>Jean-Francois.Dufour@insel.ch</email>
    </contact>
    <investigator>
      <last_name>Jean-Francois Dufour, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham Nhs Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philip Newsome, MBChB, PhD</last_name>
      <email>P.N.Newsome@bham.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Philip Newsome, MBChB, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Addenbrooke'S Hospital</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Allison, MBBS, PhD</last_name>
      <email>michael.allison@addenbrookes.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Mike Allison, MBBS, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Gateshead</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dina Mansour, MA, MBBS</last_name>
      <email>dina.mansour@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Dina Mansour, MA, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hull Royal Infirmary</name>
      <address>
        <city>Hull</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lynsey Corless, MBChB, PhD</last_name>
      <email>lynsey.corless@hey.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Lynsey Corless, MBChB, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal London Hospital, Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>William Alazawi, MBBC, PhD</last_name>
      <email>w.alazawi@nhs.net</email>
    </contact>
    <investigator>
      <last_name>William Alazawi, MBBC, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St George's University Hospitals</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Metin Devrim, MSc, MBBS</last_name>
      <email>MetinDevrim.Yalcin@stgeorges.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Metin Devrim, MSc, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Newcastle Upon Tyne Hospitals Nhs Foundation Trust</name>
      <address>
        <city>Newcastle-upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Quentin M Anstee, MBBS, PhD</last_name>
      <email>quentin.anstee@ncl.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Quentin M Anstee, MBBS, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen'S Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guru Aithal, MD, PhD</last_name>
      <email>Guru.Aithal@nuh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Guru Aithal, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals Nhs Foundation Trust</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeremy Cobbold, MBBS MA PhD</last_name>
      <email>Jeremy.Cobbold@ouh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Jeremy Cobbold, MBBS MA PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Sheridan, MBBS, PhD</last_name>
      <email>david.sheridan2@nhs.net</email>
    </contact>
    <investigator>
      <last_name>David Sheridan, MBBS, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen Alexandra Hospital</name>
      <address>
        <city>Portsmouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joanna Dowman, MBChB, PhD</last_name>
      <email>Joanna.Dowman@porthosp.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Joanna Dowman, MBChB, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NAFLD</keyword>
  <keyword>NASH</keyword>
  <keyword>Steatohepatitis</keyword>
  <keyword>Liver</keyword>
  <keyword>Cirrhosis</keyword>
  <keyword>Non-alcoholic fatty liver disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04442334
org study id: 08759
secondary id: 634413
secondary id: 777377
nct id: NCT04442334
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The European NAFLD Registry is a prospectively recruited, observational study supporting the
      study of the clinical phenotype, natural history, disease outcomes and pathophysiology of
      Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are
      to better understand the drivers of interpatient variation in disease pathophysiology and
      severity and to utilise this information to develop and validate biomarkers that, singly or
      in combination, enable detection and monitoring of disease progression and/or from NAFL
      through NASH to fibrosis and cirrhosis.
The European NAFLD Registry is a major international collaboration between clinical academics
      at leading universities across Europe, initially established with funding from the European
      Association for the Study of the Liver and through the EU FP7, H2020 and IMI2 schemes to the
      projects FLIP (Fatty Liver Inhibition of Progression), EPoS (Elucidating Pathways of
      Steatohepatitis) and LITMUS (Liver Investigation: Testing marker Utility in Steatohepatitis).

      The Registry is a non-interventional, observational study collecting cross-sectional and
      longitudinal clinical data (including clinical biochemistry/haematology, liver histology,
      comorbidities, prescribed medication and imaging data) and linked biological samples (Blood
      [Serum, Plasma], Liver Tissue, Urine, Stool) from prospectively recruited patients with
      NAFLD. Its purpose is to support clinical and translational research into disease
      pathophysiology (through development of comprehensive genetic, epigenetic, transcriptomic,
      metabolomic, proteomic and metagenomic datasets) and biomarker development/validation. It
      supports collaborative discovery science and serves as the basis for a broad international
      project to discover and validate biomarkers for NAFLD and associated medical conditions
      (LITMUS). Out-with the current study, following separate ethical approval and after separate
      consent, patients who have agreed to join the European NAFLD Registry may also agree to
      participate in a number of nested sub-studies with bi-directional sharing of data. These
      include the LITMUS Imaging Study, which will acquire additional imaging data across a range
      of modalities including, amongst others, MR-PDFF and MR-Elastography. The Registry population
      comprises adult patients (aged ≥18 years) with risk factors for non-alcoholic fatty liver
      disease (NAFLD) prospectively recruited primarily in hepatology and diabetology clinics
      and/or bariatric surgery units at centres across Europe. After receiving informed consent,
      patients will be assigned a unique study identifier (which will be used to identify all data
      and samples collected) which will allow all information to be recorded in a link-anonymised
      form.
observational model: Cohort
time perspective: Prospective
measure: Detailed Characterisation of the NAFLD Patient Phenotype
time frame: 1 day
description: Prospective patient recruitment and collection of cross-sectional clinical data is undertaken (including clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data).These data will be used to determine number of participants exhibiting specific features of NAFLD/NASH disease severity at enrolment including: histological grade of disease and fibrosis stage (assessed using the well validated NASH Clinical Research Network "NAFLD Activity Score" [NAS] and the FLIP "Steatosis - Activity - Fibrosis" [SAF] systems), frequency of common metabolic comorbidities (eg type 2 diabetes mellitus, dyslipidaemia, cardiovascular disease), and associated changes in clinical biochemistry/haematology/imaging parameters. Biological samples to support clinical and translational research into disease pathophysiology (e.g. genetic, epigenetic, transcriptomic, metabolomic, proteomic and metagenomic datasets) and biomarker development/validation will be collected.
measure: Disease Natural History
time frame: Through to study completion, an average of 5 years
description: Longitudinal follow-up of patients with NAFLD by annual review to characterise disease natural history and determine number of participants experiencing clinically significant events including the occurrence and timing of incident comorbidities and key target conditions of interest such as:
Death (cause of death)
Major Adverse Cardiovascular Events (MACE)
Hepatic (e.g. diagnosis of cirrhosis, hepatic decompensation, hepatocellular carcinoma, transplantation)
Other (diagnosis of extra-hepatic malignancy/emergency hospitalisation)
Routine clinical data generated as part of standard care will be collected annually. Clinical parameters assessed for changes indicative of alteration in disease state during follow-up include: clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data. Biological samples to support translational research into disease pathophysiology and biomarker development/validation will also be collected.
measure: Lifestyle factors: Dietary Habits
time frame: Through study completion, an average of 5 years
description: Cross-sectional and longitudinal study of dietary habits in patients with NAFLD using: Mediterranean Diet Score.
measure: Lifestyle factors: Activity/Exercise
time frame: Through study completion, an average of 5 years
description: Cross-sectional and longitudinal study of lifestyle factors (e.g. activity/sedentary behaviour/exercise levels) in patients with NAFLD using: International Physical Activity Questionnaire (IPAQ).
measure: Health Related Quality of Life: CLDQ
time frame: Through study completion, an average of 5 years
description: Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): Chronic Liver Disease Questionnaire for NAFLD NASH (CLDQ NAFLD-NASH).
measure: Health Related Quality of Life: EQ5D5L
time frame: Through study completion, an average of 5 years
description: Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): EQ-5D-5L Health
measure: Health Related Quality of Life: NASH-CHECK
time frame: Through study completion, an average of 5 years
description: Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): NASH-CHECK.
arm group label: The LITMUS Study Cohort
description: Prospectively recruited NAFLD patients, recruited according to The European NAFLD Registry study protocol.
arm group label: The LITMUS Metacohort
description: Collated data and biological samples on patients with histologically characterised NAFLD prospectively recruited at contributing academic centres across Europe.
arm group label: EFPIA Clinical Trial Cohort
description: Collated data and biological samples on patients with histologically characterised NAFLD that have participated in phase 2 and phase 3 trials of IMPs for NAFLD.
Blood (serum, plasma, whole blood, DNA, RNA), Liver tissue, Urine, stool, DNA, RNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Quentin M Anstee, MBBS, PhD
role: Principal Investigator
affiliation: Newcastle University
last name: Quentin M Anstee, MBBS, PhD
phone: +44(0)191 20 87012
email: quentin.anstee@ncl.ac.uk
last name: Kristy L Wonders, BA, MLitt
phone: +44(0)191 2083959
email: kristy.wonders@ncl.ac.uk
facility: 
status: Recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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country: Belgium
country: Finland
country: France
country: Germany
country: Greece
country: Italy
country: Netherlands
country: Portugal
country: Spain
country: Sweden
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Liver Cirrhosis
mesh term: Cardiovascular Diseases
mesh term: Dyslipidemias
sharing ipd: No