<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/NCT03760172</url>
  </required_header>
  <id_info>
    <org_study_id>PI18/01304</org_study_id>
    <nct_id>NCT03760172</nct_id>
  </id_info>
  <brief_title>Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study</brief_title>
  <acronym>INSTInCT</acronym>
  <official_title>Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Investigación Marqués de Valdecilla</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario La Fe</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Puerta de Hierro University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto de Investigación Marqués de Valdecilla</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>
      NAFLD is a common comordidity in patients with IMID, including inflammatory bowel disease and&#xD;
      psoriasis.&#xD;
&#xD;
      Nevertheless, the prevalence of NAFLD and NASH in the IMID population is not clear, and the&#xD;
      risk factors are not completely understood. Interestingly, NASH and most of IMIDs share main&#xD;
      molecular and immunological mechanisms of disease, as the inflammatory pathways depending on&#xD;
      TNFa or imbalance in T cell subtypes like Th17/Treg. This common pathogenesis may explain, at&#xD;
      least in a subset of patients, the development of NASH in the absence of classic metabolic&#xD;
      risk factor.&#xD;
&#xD;
      Thus, our main hypothesis is that in the NASH assciated to IMIDs two different phenotypes&#xD;
      co-exist.&#xD;
&#xD;
      First, a predominantly inflammatory phenotype, and not associated to the metabolic syndrome&#xD;
      ande second, a predominantly metabolic phenptype, strongly associated to he metabolic&#xD;
      syndrome.&#xD;
&#xD;
      In this way, we believe that in a particular subset of NAFLD patients, NASH could be&#xD;
      considered as an IMID, as most of the definiting features of IMIDs are present. To&#xD;
      demonstrate our hypothesis, we consider a two-stage study. First, we will determine the NAFLD&#xD;
      and NASH prevalence in a cohort of well-characterized IMID patients and controls. Second, we&#xD;
      will adress the molecular and immunophenotype characterization in liver biopsies of NASH&#xD;
      patients with and without the co-existence of IMIDs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 7, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Other</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Prevalence of NAFLD in patients with IMID</measure>
    <time_frame>January 2019 - December 2020</time_frame>
    <description>Prevalence of NAFLD in patients with IMID</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">7300</enrollment>
  <condition>Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist</condition>
  <arm_group>
    <arm_group_label>Prevalence of NAFLD in patients with IMID</arm_group_label>
    <description>To analyze the global prevalence of NAFLD in patients with an immune-mediated inflammatory disease IMID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prevalence of High-risk NASH in patients with IMID</arm_group_label>
    <description>To evaluate the prevalence of high-risk NASH (NASH with advanced fibrosis) in patients with IMID through clinical, radiological and histological evaluation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immunophenptypic characterization</arm_group_label>
    <description>To investigate the existence of common and differential immunophenotypes between the subjects with NASH with and without IMID, and patients with IMID without liver involment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Genetic and Molecular characterization</arm_group_label>
    <description>Liver molecular characterization of NASH associated to IMID</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      biopsy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        all population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NAFLD with biopsy proven disease above 18 years&#xD;
&#xD;
          -  IMID patients above 18 years&#xD;
&#xD;
          -  All participants must give informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had any clinical evidence of malignancy&#xD;
&#xD;
          -  Other secondary cause of chronic liver disease. Alternative causes of liver disease&#xD;
             included excessive alcohol intake (higher than 20 g/day in women and 30 g/day in men),&#xD;
             viral hepatitis, chronic alcohol consumption, autoimmune hepatitis, Wilson´s disease,&#xD;
             alpha-1-antitripsine deficiency, inborn errors of metabolism or drug induced liver&#xD;
             injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Maria Teresa Arias Loste, MD</last_name>
    <phone>942202520</phone>
    <email>mteresa.arias@scsalud.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Maria Teresa Arias Loste, MD</last_name>
      <phone>942204089</phone>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto de Investigación Marqués de Valdecilla</investigator_affiliation>
    <investigator_full_name>MARIA CINTA ALMENARA MIRAMON</investigator_full_name>
    <investigator_title>Dr. Javier Crespo Garcia</investigator_title>
  </responsible_party>
  <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>
  </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/NCT03760172
org study id: PI18/01304
nct id: NCT03760172
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
NAFLD is a common comordidity in patients with IMID, including inflammatory bowel disease and
      psoriasis.

      Nevertheless, the prevalence of NAFLD and NASH in the IMID population is not clear, and the
      risk factors are not completely understood. Interestingly, NASH and most of IMIDs share main
      molecular and immunological mechanisms of disease, as the inflammatory pathways depending on
      TNFa or imbalance in T cell subtypes like Th17/Treg. This common pathogenesis may explain, at
      least in a subset of patients, the development of NASH in the absence of classic metabolic
      risk factor.

      Thus, our main hypothesis is that in the NASH assciated to IMIDs two different phenotypes
      co-exist.

      First, a predominantly inflammatory phenotype, and not associated to the metabolic syndrome
      ande second, a predominantly metabolic phenptype, strongly associated to he metabolic
      syndrome.

      In this way, we believe that in a particular subset of NAFLD patients, NASH could be
      considered as an IMID, as most of the definiting features of IMIDs are present. To
      demonstrate our hypothesis, we consider a two-stage study. First, we will determine the NAFLD
      and NASH prevalence in a cohort of well-characterized IMID patients and controls. Second, we
      will adress the molecular and immunophenotype characterization in liver biopsies of NASH
      patients with and without the co-existence of IMIDs.
observational model: Cohort
time perspective: Other
measure: Prevalence of NAFLD in patients with IMID
time frame: January 2019 - December 2020
description: Prevalence of NAFLD in patients with IMID
arm group label: Prevalence of NAFLD in patients with IMID
description: To analyze the global prevalence of NAFLD in patients with an immune-mediated inflammatory disease IMID
arm group label: Prevalence of High-risk NASH in patients with IMID
description: To evaluate the prevalence of high-risk NASH (NASH with advanced fibrosis) in patients with IMID through clinical, radiological and histological evaluation
arm group label: Immunophenptypic characterization
description: To investigate the existence of common and differential immunophenotypes between the subjects with NASH with and without IMID, and patients with IMID without liver involment
arm group label: Genetic and Molecular characterization
description: Liver molecular characterization of NASH associated to IMID
biopsy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Teresa Arias Loste, MD
phone: 942202520
email: mteresa.arias@scsalud.es
facility: 
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Instituto de Investigación Marqués de Valdecilla
investigator full name: MARIA CINTA ALMENARA MIRAMON
investigator title: Dr. Javier Crespo Garcia
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease