<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/NCT03838458</url>
  </required_header>
  <id_info>
    <org_study_id>Hypospadic prepuce structure</org_study_id>
    <nct_id>NCT03838458</nct_id>
  </id_info>
  <brief_title>Molecular and Structural Comparison of Hypospadic and Normal Children Prepuces</brief_title>
  <official_title>Comparison of Structural and Molecular Genetic Properties Between Normal and Hypospadic Children's Prepuces</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Trakya University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Trakya 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>
      The aim of this study is to compare prepuce tissue samples from healthy male children who&#xD;
      applied for circumcision and children with isolated hypospadias. Estrogen receptor 1 (ER1),&#xD;
      androgen receptor (AR), FGFR2, transforming growth factor beta (TGF beta) and HOXA13 gene&#xD;
      expression in the prepuce is planned to investigate via polymerase chain reaction (PCR)&#xD;
      method. Mucosal vascular and nerve densities, and extracellular matrix density of laminin and&#xD;
      collagen protein is planned to investigate via immunohistochemical examination.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">March 10, 2020</completion_date>
  <primary_completion_date type="Actual">January 7, 2020</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>Genetic analysis 1</measure>
    <time_frame>1 year</time_frame>
    <description>Androgen receptor (AR) gene PCR analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genetic analysis 2</measure>
    <time_frame>1 year</time_frame>
    <description>Estrogen receptor 1 (ER1) gene PCR analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genetic analysis 3</measure>
    <time_frame>1 year</time_frame>
    <description>FGFR2 gene PCR analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genetic analysis 4</measure>
    <time_frame>1 year</time_frame>
    <description>TGF beta gene PCR analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genetic analysis 5</measure>
    <time_frame>1 year</time_frame>
    <description>HOXA13 gene PCR analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immunohistochemical study 1</measure>
    <time_frame>1 year</time_frame>
    <description>Mucosal vessel density is planned to determine via CD34</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immunohistochemical study 2</measure>
    <time_frame>1 year</time_frame>
    <description>Mucosal nerve density is planned to determine via PGP 9.5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Histological study 1</measure>
    <time_frame>1 year</time_frame>
    <description>Laminin is planned to determine in extracellular matrix via light microscope</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Histological study 2</measure>
    <time_frame>1 year</time_frame>
    <description>Collagen is planned to determine in extracellular matrix via light microscope</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Hypospadias</condition>
  <arm_group>
    <arm_group_label>Study</arm_group_label>
    <description>Children with isolated hypospadias</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Children with planned circumcision</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Preputial tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        0-18 years old pediatric male population, patients with isolated hypospadias are study&#xD;
        group, patients with planned circumcision are control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To apply for circumcision, not to have any genitourinary abnormalities/conditions for&#xD;
             control group.&#xD;
&#xD;
          -  To have isolated hypospadias for study group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To have genitourinary surgery before.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dincer Avlan, Profesor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Trakya University Faculty of Medicine, Pediatric Surgery Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Trakya University Faculty of Medicine</name>
      <address>
        <city>Edirne</city>
        <zip>22030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>April 25, 2020</last_update_submitted>
  <last_update_submitted_qc>April 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Trakya University</investigator_affiliation>
    <investigator_full_name>Irem Inanc</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>hypospadias</keyword>
  <keyword>prepuce</keyword>
  <keyword>HOXA13</keyword>
  <keyword>FGFR2</keyword>
  <keyword>TGF beta</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypospadias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03838458
org study id: Hypospadic prepuce structure
nct id: NCT03838458
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare prepuce tissue samples from healthy male children who
      applied for circumcision and children with isolated hypospadias. Estrogen receptor 1 (ER1),
      androgen receptor (AR), FGFR2, transforming growth factor beta (TGF beta) and HOXA13 gene
      expression in the prepuce is planned to investigate via polymerase chain reaction (PCR)
      method. Mucosal vascular and nerve densities, and extracellular matrix density of laminin and
      collagen protein is planned to investigate via immunohistochemical examination.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Genetic analysis 1
time frame: 1 year
description: Androgen receptor (AR) gene PCR analysis
measure: Genetic analysis 2
time frame: 1 year
description: Estrogen receptor 1 (ER1) gene PCR analysis
measure: Genetic analysis 3
time frame: 1 year
description: FGFR2 gene PCR analysis
measure: Genetic analysis 4
time frame: 1 year
description: TGF beta gene PCR analysis
measure: Genetic analysis 5
time frame: 1 year
description: HOXA13 gene PCR analysis
measure: Immunohistochemical study 1
time frame: 1 year
description: Mucosal vessel density is planned to determine via CD34
measure: Immunohistochemical study 2
time frame: 1 year
description: Mucosal nerve density is planned to determine via PGP 9.5
measure: Histological study 1
time frame: 1 year
description: Laminin is planned to determine in extracellular matrix via light microscope
measure: Histological study 2
time frame: 1 year
description: Collagen is planned to determine in extracellular matrix via light microscope
arm group label: Study
description: Children with isolated hypospadias
arm group label: Control
description: Children with planned circumcision
Preputial tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
minimum age: N/A
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dincer Avlan, Profesor, MD
role: Principal Investigator
affiliation: Trakya University Faculty of Medicine, Pediatric Surgery Department
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Trakya University
investigator full name: Irem Inanc
investigator title: MD
mesh term: Hypospadias
sharing ipd: Undecided