<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/NCT01720628</url>
  </required_header>
  <id_info>
    <org_study_id>AFV-5813</org_study_id>
    <nct_id>NCT01720628</nct_id>
  </id_info>
  <brief_title>The Relationship Between Serum Levels of Angiogenin, bFGF, VEGF and Ocular Involvement in Patients With Behçet's Disease</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turkish Ophthalmology Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Turkish Ophthalmology Society</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial&#xD;
      dysfunction plays a prominent role in the pathogenesis of the disease, we considered&#xD;
      angiogenic cytokines as an interesting target for investigation in BD. The aim of this study&#xD;
      was to investigate the possible role of angiogenin, vascular endothelial growth factor (VEGF)&#xD;
      and basic fibroblast growth factor (bFGF) in the pathogenesis of BD.&#xD;
&#xD;
      Design and Methods: Sixty five patients with BD and 21 healthy control subjects were included&#xD;
      in the study. Serum angiogenin, bFGF and VEGF concentrations were determined by using in&#xD;
      vitro enzyme immunoassay (ELISA) kits according to the manufacturer's instructions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">November 2011</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>Serum levels of angiogenin in Behçet's patients with or without ocular involvement</measure>
    <time_frame>1 year</time_frame>
    <description>The median serum angiogenin level was significantly higher in all patients with BD than controls (P=0.001). However there was no statistically significant difference between all patients and patients with or without ocular involvement. The mean serum bFGF and the median serum VEGF levels were higher in patients with ocular involvement than all patients, patients without ocular involvement and controls. But these differences did not reach statistical significance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum levels of bFGF in Behçet's patients with or without ocular involvement</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Serum levels of VEGF in Behçet's patients with or without ocular involvement</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">86</enrollment>
  <condition>Behçet's Disease</condition>
  <arm_group>
    <arm_group_label>Behçet's patients</arm_group_label>
    <description>Serum levels of angiogenin, bFGF, VEGF levels in Behçet's patients with ocular involvement group, without ocular involvement group and control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>serum levels of angiogenin, bFGF, VEGF</intervention_name>
    <description>Behçet's patients</description>
    <arm_group_label>Behçet's patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Turkish patients fulfilling the international diagnostic criteria for Behçet's disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18-65&#xD;
&#xD;
          -  fulfilling the international diagnostic criteria for Behçet's disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  to have another systemic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ali yalçındağ</last_name>
    <role>Study Director</role>
    <affiliation>* Dışkapı Yıldırım Beyazıt Training and Research Hospital, Department of Clinical Biochemistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankara University, Faculty of Medicine, Department of Ophthalmology</name>
      <address>
        <city>Ankara</city>
        <zip>06620</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>October 31, 2012</last_update_submitted>
  <last_update_submitted_qc>October 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Turkish Ophthalmology Society</investigator_affiliation>
    <investigator_full_name>Yeşim Gedik Oğuz</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Angiogenin, Behçet's disease, bFGF, VEGF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behcet Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angiogenin</mesh_term>
  </intervention_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/NCT01720628
org study id: AFV-5813
nct id: NCT01720628
lead sponsor: 
has dmc: Yes
Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial
      dysfunction plays a prominent role in the pathogenesis of the disease, we considered
      angiogenic cytokines as an interesting target for investigation in BD. The aim of this study
      was to investigate the possible role of angiogenin, vascular endothelial growth factor (VEGF)
      and basic fibroblast growth factor (bFGF) in the pathogenesis of BD.

      Design and Methods: Sixty five patients with BD and 21 healthy control subjects were included
      in the study. Serum angiogenin, bFGF and VEGF concentrations were determined by using in
      vitro enzyme immunoassay (ELISA) kits according to the manufacturer's instructions.
observational model: Case-Control
time perspective: Prospective
measure: Serum levels of angiogenin in Behçet's patients with or without ocular involvement
time frame: 1 year
description: The median serum angiogenin level was significantly higher in all patients with BD than controls (P=0.001). However there was no statistically significant difference between all patients and patients with or without ocular involvement. The mean serum bFGF and the median serum VEGF levels were higher in patients with ocular involvement than all patients, patients without ocular involvement and controls. But these differences did not reach statistical significance.
measure: Serum levels of bFGF in Behçet's patients with or without ocular involvement
time frame: 1 year
measure: Serum levels of VEGF in Behçet's patients with or without ocular involvement
time frame: 1 year
arm group label: Behçet's patients
description: Serum levels of angiogenin, bFGF, VEGF levels in Behçet's patients with ocular involvement group, without ocular involvement group and control group
intervention type: Other
intervention name: serum levels of angiogenin, bFGF, VEGF
description: Behçet's patients
arm group label: Behçet's patients
serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ali yalçındağ
role: Study Director
affiliation: * Dışkapı Yıldırım Beyazıt Training and Research Hospital, Department of Clinical Biochemistry
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Turkish Ophthalmology Society
investigator full name: Yeşim Gedik Oğuz
investigator title: MD
mesh term: Behcet Syndrome
mesh term: Angiogenin