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/NCT06042296</url>
    </required_header>
    <id_info>
      <org_study_id>BAUNHYILDIRIM-1</org_study_id>
      <nct_id>NCT06042296</nct_id>
    </id_info>
    <brief_title>Expression of CD44, PCNA and E-cadherin in Pterygium Tissue</brief_title>
    <official_title>Expression of CD44, PCNA and E-cadherin in Pterygium Tissue</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Balikesir University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Balikesir University</source>
    <oversight_info>
      <has_dmc>No</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>
        Purpose: Pterygium is a common ocular surface disease defined by fibrovascular conjunctival&#xD;
        growth extending onto the cornea. Its pathogenesis remains unclear. In severe cases, it may&#xD;
        extend into the central cornea, inducing irregular corneal astigmatism and causing loss of&#xD;
        vision. CD44( phagocytic glycoprotein-1 ) is involved in the organization of certain cellular&#xD;
        processes, for instance, cell adhesion, division, and migration, by binding with its main&#xD;
        ligand, hyaluronic acid. Proliferating cell nuclear antigen (PCNA) is a proliferation marker&#xD;
        in the nucleus. E-cadherin is a calcium-dependent transmembrane glycoprotein that plays a&#xD;
        significant role in the protection of tissue integrity and cell-to-cell adhesion. This study&#xD;
        aimed to determine the role of CD44, proliferating cell nuclear antigen (PCNA), and&#xD;
        E-cadherin in pterygium formation and recurrence.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Methods:60 patients with pterygium will be enrolled in the study and conjunctival samples&#xD;
        will be collected from 30 patients to form the control group. CD44, PCNA and E-cadherin&#xD;
        expressions in surgically removed pterygium will be compared with tissue samples from normal&#xD;
        control group.&#xD;
  &#xD;
        IBM SPSS (statistical software) version 26.0 will be used for statistical analyses.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>4 Months</target_duration>
    <primary_outcome>
      <measure>Immunohistochemistry</measure>
      <time_frame>up to three weeks after pterygium surgery</time_frame>
      <description>Thin sections will be taken from paraffin embedded tissue samples and placed on barcode glass slides After deparaffinization and rehydration, the sections will be subjected to histopathological evaluation using hematoxylin and eosin staining.We use primary antibodies against CD44 (1:50 dilution) and E-cadherin (1:200 dilution), and a human monoclonal antibody against PCNA (1:100 dilution) for antigen retrieval</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Pterygium</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <description>group 1 -control group normal conjunctiva from 30 patients</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group 2 primary pterygia</arm_group_label>
      <description>primary pterygia samples from 30 patients</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group 3 recurrent pterygia</arm_group_label>
      <description>recurrent pterygia samples from 30 patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Expression of CD44, E-cadherin and PCNA</intervention_name>
      <description>The investigators use primary antibodies against CD44 (1:50 dilution) and E-cadherin (1:200 dilution), and a human monoclonal antibody against PCNA (1:100 dilution) for antigen retrieval. Histopathological and immunohistochemical staining findings will be reported using a Nikon light microscope and an image analysis system (Nikon Instruments Europe BV)</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>group 2 primary pterygia</arm_group_label>
      <arm_group_label>group 3 recurrent pterygia</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          60 patient with primary and recurrent pterygium&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria: patient with pterygium -&#xD;
  &#xD;
          Exclusion Criteria: patient with pseudopterygium&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>HÜMEYRA YILDIRIM</last_name>
      <role>Principal Investigator</role>
      <affiliation>Balıkesir Medical Faculty</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>HÜMEYRA YILDIRIM</last_name>
      <phone>05305244841</phone>
      <email>balikesirhumeyra@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hümeyra Yildirim</name>
        <address>
          <city>Balıkesir</city>
          <zip>10100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>HÜMEYRA YILDIRIM</last_name>
        <phone>905305244841</phone>
        <email>balikesirhumeyra@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Balikesir University</investigator_affiliation>
      <investigator_full_name>HUMEYRA YILDIRIM</investigator_full_name>
      <investigator_title>Expression of CD44, PCNA and E-cadherin in pterygium tissue</investigator_title>
    </responsible_party>
    <keyword>PCNA,</keyword>
    <keyword>cd44</keyword>
    <keyword>e-cadherin</keyword>
    <keyword>immunohistochemistry</keyword>
    <keyword>pterygium</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pterygium</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/NCT06042296
  org study id: BAUNHYILDIRIM-1
  nct id: NCT06042296
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Purpose: Pterygium is a common ocular surface disease defined by fibrovascular conjunctival
        growth extending onto the cornea. Its pathogenesis remains unclear. In severe cases, it may
        extend into the central cornea, inducing irregular corneal astigmatism and causing loss of
        vision. CD44( phagocytic glycoprotein-1 ) is involved in the organization of certain cellular
        processes, for instance, cell adhesion, division, and migration, by binding with its main
        ligand, hyaluronic acid. Proliferating cell nuclear antigen (PCNA) is a proliferation marker
        in the nucleus. E-cadherin is a calcium-dependent transmembrane glycoprotein that plays a
        significant role in the protection of tissue integrity and cell-to-cell adhesion. This study
        aimed to determine the role of CD44, proliferating cell nuclear antigen (PCNA), and
        E-cadherin in pterygium formation and recurrence.
  Methods:60 patients with pterygium will be enrolled in the study and conjunctival samples
        will be collected from 30 patients to form the control group. CD44, PCNA and E-cadherin
        expressions in surgically removed pterygium will be compared with tissue samples from normal
        control group.
  
        IBM SPSS (statistical software) version 26.0 will be used for statistical analyses.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Immunohistochemistry
  time frame: up to three weeks after pterygium surgery
  description: Thin sections will be taken from paraffin embedded tissue samples and placed on barcode glass slides After deparaffinization and rehydration, the sections will be subjected to histopathological evaluation using hematoxylin and eosin staining.We use primary antibodies against CD44 (1:50 dilution) and E-cadherin (1:200 dilution), and a human monoclonal antibody against PCNA (1:100 dilution) for antigen retrieval
  arm group label: control group
  description: group 1 -control group normal conjunctiva from 30 patients
  arm group label: group 2 primary pterygia
  description: primary pterygia samples from 30 patients
  arm group label: group 3 recurrent pterygia
  description: recurrent pterygia samples from 30 patients
  intervention type: Other
  intervention name: Expression of CD44, E-cadherin and PCNA
  description: The investigators use primary antibodies against CD44 (1:50 dilution) and E-cadherin (1:200 dilution), and a human monoclonal antibody against PCNA (1:100 dilution) for antigen retrieval. Histopathological and immunohistochemical staining findings will be reported using a Nikon light microscope and an image analysis system (Nikon Instruments Europe BV)
  arm group label: control group
  arm group label: group 2 primary pterygia
  arm group label: group 3 recurrent pterygia
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: HÜMEYRA YILDIRIM
  role: Principal Investigator
  affiliation: Balıkesir Medical Faculty
  last name: HÜMEYRA YILDIRIM
  phone: 05305244841
  email: balikesirhumeyra@gmail.com
  facility: 
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Balikesir University
  investigator full name: HUMEYRA YILDIRIM
  investigator title: Expression of CD44, PCNA and E-cadherin in pterygium tissue
  mesh term: Pterygium
  sharing ipd: No