<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/NCT03276039</url>
  </required_header>
  <id_info>
    <org_study_id>456</org_study_id>
    <nct_id>NCT03276039</nct_id>
  </id_info>
  <brief_title>Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus</brief_title>
  <official_title>Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus: A Comparative Egyptian Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      This study included 70 subjects divided into 3 groups. Group I included 25 patients with&#xD;
      NAFLD. Group II included 25 patients with NAFLD and chronic HCV. Group III: included 20&#xD;
      controls. Abdominal ultrasound was done to patients and controls. Plasma pentraxin-3 (PTX3)&#xD;
      was measured using ELISA. Comparison between three groups was done regarding plasma&#xD;
      pentraxin-3. Higher levels of plasma PTX3 were detected in NAFLD patients irrespective of&#xD;
      presence or absence of chronic HCV infection. Plasma PTX3 could be used as a non-invasive&#xD;
      test for prediction of metabolic syndrome in the high-risk population with high sensitivity&#xD;
      and moderate specificity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2014</start_date>
  <completion_date type="Actual">July 30, 2016</completion_date>
  <primary_completion_date type="Actual">April 15, 2016</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma pentraxin-3 as a non invasive diagnostic marker in diagnosis of NAFLD in comparison to it's levels in patients with NAFLD and chronic hepatitis C viral infection</measure>
    <time_frame>1 year</time_frame>
    <description>Measurement of plasma pentraxin-3 in patients with NAFLD in comparison to it's levels in patients with hepatic steatosis on top of HCV and normal controls</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Non Alcoholic Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>25 patients with non-alcoholic fatty liver disease</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>25 patients with NAFLD and chronic HCV</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>20 healthy controls</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>plasma pentraxin-3</intervention_name>
    <description>Plasma pentraxin-3 was measured using ELISA</description>
    <arm_group_label>20 healthy controls</arm_group_label>
    <arm_group_label>25 patients with NAFLD and chronic HCV</arm_group_label>
    <arm_group_label>25 patients with non-alcoholic fatty liver disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        50 adult Egyptian patients collected from Gastroenterology Unit, Internal Medicine, and&#xD;
        Tropical Medicine Departments, were included. Additionally, 20 apparently healthy subjects&#xD;
        were included as the control group. They were classified into three groups: Group I:&#xD;
        included 25 patients with NAFLD diagnosed by radiological features and by exclusion of&#xD;
        other causes of fatty liver.&#xD;
&#xD;
        Group II: included 25 patients with radiological features of NAFLD and laboratory evidence&#xD;
        of chronic hepatitis C viral infection (positive PCR).&#xD;
&#xD;
        Group III: included 20 apparently healthy control subjects with negative medical history,&#xD;
        normal physical examination, and normal laboratory and radiological examination.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with NAFLD.&#xD;
&#xD;
          -  Patients with NAFLD and chronic hepatitis C viral infection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or past consumption of significant amount of alcohol more than 21 drinks and&#xD;
             14 drinks per week for men and women respectively.&#xD;
&#xD;
          -  Patients receiving Drugs which cause fatty liver as amiodarone, diliazem, tamoxifen,&#xD;
             steroids.&#xD;
&#xD;
          -  Patients who take statins as it has lowering effect on plasma PTX3.&#xD;
&#xD;
          -  Patients having any clinical evidence of hepatic decompensation, such as hepatic&#xD;
             encephalopathy, ascites, variceal bleeding, elevated serum bilirubin level to more&#xD;
             than two folds the upper limit of normal.&#xD;
&#xD;
          -  Patients with heart failure.&#xD;
&#xD;
          -  Patients with autoimmune rheumatic disease.&#xD;
&#xD;
          -  Patients with chronic kidney diseases.&#xD;
&#xD;
          -  Patients with sepsis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Shereen Abou Bakr Saleh</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
    <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/NCT03276039
org study id: 456
nct id: NCT03276039
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study included 70 subjects divided into 3 groups. Group I included 25 patients with
      NAFLD. Group II included 25 patients with NAFLD and chronic HCV. Group III: included 20
      controls. Abdominal ultrasound was done to patients and controls. Plasma pentraxin-3 (PTX3)
      was measured using ELISA. Comparison between three groups was done regarding plasma
      pentraxin-3. Higher levels of plasma PTX3 were detected in NAFLD patients irrespective of
      presence or absence of chronic HCV infection. Plasma PTX3 could be used as a non-invasive
      test for prediction of metabolic syndrome in the high-risk population with high sensitivity
      and moderate specificity.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Plasma pentraxin-3 as a non invasive diagnostic marker in diagnosis of NAFLD in comparison to it's levels in patients with NAFLD and chronic hepatitis C viral infection
time frame: 1 year
description: Measurement of plasma pentraxin-3 in patients with NAFLD in comparison to it's levels in patients with hepatic steatosis on top of HCV and normal controls
arm group label: 25 patients with non-alcoholic fatty liver disease
arm group label: 25 patients with NAFLD and chronic HCV
arm group label: 20 healthy controls
intervention type: Diagnostic Test
intervention name: plasma pentraxin-3
description: Plasma pentraxin-3 was measured using ELISA
arm group label: 20 healthy controls
arm group label: 25 patients with NAFLD and chronic HCV
arm group label: 25 patients with non-alcoholic fatty liver disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Shereen Abou Bakr Saleh
investigator title: Assistant Professor
mesh term: Hepatitis C
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease