<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/NCT02188004</url>
  </required_header>
  <id_info>
    <org_study_id>HPV-EPI-001</org_study_id>
    <nct_id>NCT02188004</nct_id>
  </id_info>
  <brief_title>The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases</brief_title>
  <official_title>The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases In Male and Female Aged Over 18 Years In China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jun Zhang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Liuzhou center of disease prevention and control</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xiamen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      primary purpose:Evaluate the prevalence and incidence of HPV infection and related diseases&#xD;
      in subjects.&#xD;
&#xD;
      Secondary purpose:Analyze risk factors of HPV infection and related diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>prevalence and incidence of HPV infection</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate the prevalence and incidence of HPV infection and related diseases in subjects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>risk factors of HPV infection and related diseases</measure>
    <time_frame>1 year</time_frame>
    <description>Analyze risk factors of HPV infection and related diseases.</description>
  </secondary_outcome>
  <enrollment type="Actual">4691</enrollment>
  <condition>Human Papillomavirus Infection</condition>
  <condition>Genital Warts</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Male:Two swabs were used to collect exfoliated skin cells from the coronal sulcus&#xD;
      /glans/shaft and anal&#xD;
&#xD;
      Female:Three swabs were used to collect exfoliated skin cells from the vagina，vulva and anal&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        5000 healthy volunteers will be recruited from the residents of Liuzhou through&#xD;
        advertisment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 18 to 55 years;&#xD;
&#xD;
          -  residents of the study site;&#xD;
&#xD;
          -  at least one sex partner;&#xD;
&#xD;
          -  Be able to understand and comply with the request of the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant;&#xD;
&#xD;
          -  has received HPV vaccines.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Zhang</last_name>
    <role>Study Chair</role>
    <affiliation>Xiamen University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ming-Qiang Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liuzhou center of disease prevention and control</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Liuzhou Center of disease prevention and control</name>
      <address>
        <city>Liuzhou</city>
        <state>Guangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>May 5, 2019</last_update_submitted>
  <last_update_submitted_qc>May 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Xiamen University</investigator_affiliation>
    <investigator_full_name>Jun Zhang</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>HPV</keyword>
  <keyword>genital warts</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Papillomavirus Infections</mesh_term>
    <mesh_term>Condylomata Acuminata</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/NCT02188004
org study id: HPV-EPI-001
nct id: NCT02188004
lead sponsor: 
collaborator: 
has dmc: No
primary purpose:Evaluate the prevalence and incidence of HPV infection and related diseases
      in subjects.

      Secondary purpose:Analyze risk factors of HPV infection and related diseases.
observational model: Cohort
time perspective: Prospective
measure: prevalence and incidence of HPV infection
time frame: 1 year
description: Evaluate the prevalence and incidence of HPV infection and related diseases in subjects
measure: risk factors of HPV infection and related diseases
time frame: 1 year
description: Analyze risk factors of HPV infection and related diseases.
Male:Two swabs were used to collect exfoliated skin cells from the coronal sulcus
      /glans/shaft and anal

      Female:Three swabs were used to collect exfoliated skin cells from the vagina，vulva and anal
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jun Zhang
role: Study Chair
affiliation: Xiamen University
last name: Ming-Qiang Li
role: Principal Investigator
affiliation: Liuzhou center of disease prevention and control
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Xiamen University
investigator full name: Jun Zhang
investigator title: professor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Papillomavirus Infections
mesh term: Condylomata Acuminata