<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/NCT01664962</url>
  </required_header>
  <id_info>
    <org_study_id>920080002</org_study_id>
    <nct_id>NCT01664962</nct_id>
  </id_info>
  <brief_title>Search for Genetic Basis of Vulvodynia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Galilee Hospital-Nahariya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Galilee Hospital-Nahariya</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the possibility of an association between&#xD;
      Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic&#xD;
      markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase&#xD;
      (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The short-term goal proposed for the current study was to investigate the possibility of an&#xD;
      association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and&#xD;
      polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding&#xD;
      heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).&#xD;
&#xD;
      Eight polymorphic SNPs in the three different genes suspected to be involved in LPV has been&#xD;
      examined as follow:&#xD;
&#xD;
        1. HSPE gene: Four polymorphic SNPs: rs4693608, rs11099592, rs6856901 and rs4364254 that&#xD;
           were found to be informative in the Ashkenazi Jewish population&#xD;
&#xD;
        2. TRPV1 gene: Two polymorphic SNPs: rs222747 and rs8065080.&#xD;
&#xD;
        3. NGF gene: A novel T to C SNP in the promoter region at position -198 (rs11102930) and&#xD;
           rs6330 which was found to be associated with anxiety-related personality traits and has&#xD;
           been suggested to may affect intracellular processing and secretion of NGF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2008</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</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 association of Vulvodynia</measure>
    <time_frame>four years</time_frame>
    <description>the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">168</enrollment>
  <condition>Vulvodynia</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Women with severe Vulvodynia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>Women without vulvodynia</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Vulvodynia, Normal healthy controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:o meeting Friedrich's criteria [50] for vulva vestibulitis syndrome&#xD;
&#xD;
          -  diagnosed by a gynecological examination with LPV&#xD;
&#xD;
          -  diagnosed with a severe degree of the syndrome according to Marinoff [48]&#xD;
&#xD;
          -  classified with the primary type of the syndrome according to an interview&#xD;
&#xD;
          -  with both parents of Ashkenazi origin.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Western Galilee Hospital</name>
      <address>
        <city>Nahariya</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>August 13, 2012</last_update_submitted>
  <last_update_submitted_qc>August 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Galilee Hospital-Nahariya</investigator_affiliation>
    <investigator_full_name>Prof. Jacob Bornstein</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vulvodynia</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/NCT01664962
org study id: 920080002
nct id: NCT01664962
lead sponsor: 
The purpose of this study is to investigate the possibility of an association between
      Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic
      markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase
      (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).
The short-term goal proposed for the current study was to investigate the possibility of an
      association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and
      polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding
      heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

      Eight polymorphic SNPs in the three different genes suspected to be involved in LPV has been
      examined as follow:

        1. HSPE gene: Four polymorphic SNPs: rs4693608, rs11099592, rs6856901 and rs4364254 that
           were found to be informative in the Ashkenazi Jewish population

        2. TRPV1 gene: Two polymorphic SNPs: rs222747 and rs8065080.

        3. NGF gene: A novel T to C SNP in the promoter region at position -198 (rs11102930) and
           rs6330 which was found to be associated with anxiety-related personality traits and has
           been suggested to may affect intracellular processing and secretion of NGF.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Genetic association of Vulvodynia
time frame: four years
description: the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).
arm group label: Patients
description: Women with severe Vulvodynia
arm group label: Healthy controls
description: Women without vulvodynia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Western Galilee Hospital-Nahariya
investigator full name: Prof. Jacob Bornstein
investigator title: Principal Investigator
mesh term: Vulvodynia