xml: <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/NCT05994677</url>
    </required_header>
    <id_info>
      <org_study_id>AssiutUFMGIT</org_study_id>
      <nct_id>NCT05994677</nct_id>
    </id_info>
    <brief_title>Psoriasis and Non Alcoholic Steatohepatitis: Is There a Shared Inflammatory Network ?</brief_title>
    <acronym>PANASH</acronym>
    <official_title>Psoriasis and Non Alcoholic Steatohepatitis: Is There a Shared Inflammatory Network ?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
        The study is to assess frequency of NASH in Psoriatic patient and to measure the level of&#xD;
        proinflammatory cytokines including TNFα, interleukin (IL)-6 and IL-17 and anti-inflammatory&#xD;
        cytokines including IL10, IL35 by ELISA.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        • Psoriasis is a chronic proliferative and inflammatory condition of the skin. It is&#xD;
        characterized by erythematous plaques covered with silvery scales, particularly over the&#xD;
        extensor surfaces, scalp, and lumbosacral region.&#xD;
  &#xD;
        The disorder can also affect the joints and eyes. Psoriasis has no cure and the disease waxes&#xD;
        and wanes with flareups. There are several subtypes of psoriasis but the plaque type is the&#xD;
        most common and presents on the trunk, extremities, and scalp.&#xD;
  &#xD;
        Psoriasis has a prevalence ranging from 0.2% to 4.8%.&#xD;
  &#xD;
        In parallel, nonalcoholic fatty liver disease (NAFLD) is the most frequent liver disease&#xD;
        worldwide, affecting an estimated 30% of the adult population in developed countries.&#xD;
  &#xD;
        NAFLD and the metabolic syndrome are mutually and bi-directionally associated, as these two&#xD;
        pathologic condition share insulin resistance as a common pathophysiological mechanism.&#xD;
  &#xD;
        NAFLD encompasses a spectrum of pathologic conditions ranging from simple steatosis to&#xD;
        nonalcoholic steatohepatitis((NASH) featuring steatosis associated with inflammatory changes,&#xD;
        hepatocellular ballooning and pericellular fibrosis), to advanced fibrosis and cirrhosis.&#xD;
        NAFLD is projected to become the most common indication for liver transplantation in the&#xD;
        United States by 2030 .&#xD;
  &#xD;
        Over the last few years, multiple studies have demonstrated that psoriasis is associated with&#xD;
        NAFLD. The majority reported a prevalence of around 50 % (range 14.4 % to 65.5 %) for NAFLD&#xD;
        in psoriatic patients.&#xD;
  &#xD;
        The contribution of IL-17 to the pathogenesis of both psoriasis and NAFLD is intriguing. Th17&#xD;
        cells can be detected in fat tissue and IL-17 itself regulates glucose metabolism and&#xD;
        adipogenesis. Likewise, IL-17(A)-secreting Th17 cells may promote the progression from simple&#xD;
        steatosis to steatohepatitis [10] Therefore, both psoriasis and NAFLD pathogenesis seem to be&#xD;
        linked to the joint proinflammatory Th17 axis (and other cytokines such as TNFα and IL-6).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Main</measure>
      <time_frame>Baseline</time_frame>
      <description>To find out if there is a shared inflammatory network between psoriasis and Non Alcoholic Steatohepatitis or not.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>subsidiary</measure>
      <time_frame>Baseline</time_frame>
      <description>Incidence of Non Alcoholic Steatohepatitis in psoriatic patients.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">59</enrollment>
    <condition>Nash</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Psoriatic patients above 18 years not diabetic and not receiving treatment for psoriasis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Any naive psoriatic patient above 18 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any psoriatic patient who received treatment for psoriasis.&#xD;
  &#xD;
            -  Diabetic patients.&#xD;
  &#xD;
            -  Patients under 18 years old.&#xD;
  &#xD;
            -  Patient's refusal.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mohamed Adel Mohamed Hussein</investigator_full_name>
      <investigator_title>Resident doctor</investigator_title>
    </responsible_party>
    <keyword>NASH</keyword>
    <keyword>Psoriasis</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>Psoriasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994677
  org study id: AssiutUFMGIT
  nct id: NCT05994677
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study is to assess frequency of NASH in Psoriatic patient and to measure the level of
        proinflammatory cytokines including TNFα, interleukin (IL)-6 and IL-17 and anti-inflammatory
        cytokines including IL10, IL35 by ELISA.
  • Psoriasis is a chronic proliferative and inflammatory condition of the skin. It is
        characterized by erythematous plaques covered with silvery scales, particularly over the
        extensor surfaces, scalp, and lumbosacral region.
  
        The disorder can also affect the joints and eyes. Psoriasis has no cure and the disease waxes
        and wanes with flareups. There are several subtypes of psoriasis but the plaque type is the
        most common and presents on the trunk, extremities, and scalp.
  
        Psoriasis has a prevalence ranging from 0.2% to 4.8%.
  
        In parallel, nonalcoholic fatty liver disease (NAFLD) is the most frequent liver disease
        worldwide, affecting an estimated 30% of the adult population in developed countries.
  
        NAFLD and the metabolic syndrome are mutually and bi-directionally associated, as these two
        pathologic condition share insulin resistance as a common pathophysiological mechanism.
  
        NAFLD encompasses a spectrum of pathologic conditions ranging from simple steatosis to
        nonalcoholic steatohepatitis((NASH) featuring steatosis associated with inflammatory changes,
        hepatocellular ballooning and pericellular fibrosis), to advanced fibrosis and cirrhosis.
        NAFLD is projected to become the most common indication for liver transplantation in the
        United States by 2030 .
  
        Over the last few years, multiple studies have demonstrated that psoriasis is associated with
        NAFLD. The majority reported a prevalence of around 50 % (range 14.4 % to 65.5 %) for NAFLD
        in psoriatic patients.
  
        The contribution of IL-17 to the pathogenesis of both psoriasis and NAFLD is intriguing. Th17
        cells can be detected in fat tissue and IL-17 itself regulates glucose metabolism and
        adipogenesis. Likewise, IL-17(A)-secreting Th17 cells may promote the progression from simple
        steatosis to steatohepatitis [10] Therefore, both psoriasis and NAFLD pathogenesis seem to be
        linked to the joint proinflammatory Th17 axis (and other cytokines such as TNFα and IL-6).
  observational model: Case-Control
  time perspective: Prospective
  measure: Main
  time frame: Baseline
  description: To find out if there is a shared inflammatory network between psoriasis and Non Alcoholic Steatohepatitis or not.
  measure: subsidiary
  time frame: Baseline
  description: Incidence of Non Alcoholic Steatohepatitis in psoriatic patients.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mohamed Adel Mohamed Hussein
  investigator title: Resident doctor
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease
  mesh term: Psoriasis
  sharing ipd: No