<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/NCT01717443</url>
  </required_header>
  <id_info>
    <org_study_id>NL38266.091.11</org_study_id>
    <nct_id>NCT01717443</nct_id>
  </id_info>
  <brief_title>Genital HPV Infections Before and After Renal Transplantation</brief_title>
  <official_title>The Incidence, Prevalence and Genotype of Genital Human Papillomavirus Infections in Females Before and After Renal Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Nijmegen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dutch Kidney Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medical Center Nijmegen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the prevalence, incidence and genotype of anogenital&#xD;
      HPV infections in women before and after renal transplantation. With this information the&#xD;
      investigators can determine the value of vaccination in patients waiting for renal&#xD;
      transplantation in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each year about 800 renal transplantations are performed in the Netherlands. The current&#xD;
      immunosuppressive strategies have led to a 1-year patient and graft survival of more than&#xD;
      90%. This high survival rate urges medical specialists to pay increasing attention to the&#xD;
      long-term side effects of immunosuppressive medication, such as virus-associated cancers. An&#xD;
      example of an oncogenic virus is the high risk Human Papillomavirus (hrHPV) which is related&#xD;
      to (pre)malignancies of the anogenital tract e.g. cervix, vulva and anus. These malignancies&#xD;
      are among the most common malignancies in renal transplant recipients (RTRs). The incidence&#xD;
      of hrHPV-related cervical and vulvar malignancies is increased up to a 100-fold in RTRs&#xD;
      compared to the general population. There is limited literature on the exact behaviour of HPV&#xD;
      infection related anogenital (pre)malignancies in RTRs. A part of these (pre)malignancies are&#xD;
      probably already present at the time of transplantation while others develop in the years&#xD;
      after transplantation. With gynaecological examination the investigators can diagnose&#xD;
      anogenital (pre)malignancies before transplantation so treatment, if necessary, can commence&#xD;
      before transplantation. Knowledge about HPV status before and after transplantation gives&#xD;
      insight in the natural course of the HPV infection in this group of patients and with this&#xD;
      information the investigators can determine the value of vaccination in patients waiting for&#xD;
      renal transplantation in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">October 2015</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 of genital HPV infection before and after renal transplantation in women with end stage renal disease</measure>
    <time_frame>6 months before and 6 months after renal transplantation</time_frame>
    <description>The difference between post-transplantation prevalence (two HPV tests in 6 months after transplantation)and pre-transplantation prevalence (two HPV tests in 6 months before transplantation) will be compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of genital HPV infection before and after renal transplantation</measure>
    <time_frame>Assessed every 3 months for 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genotype of the HPV infection per time point</measure>
    <time_frame>Assessed every 3 months for 2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">65</enrollment>
  <condition>Human Papillomavirus Infections</condition>
  <arm_group>
    <arm_group_label>Women, renal disease, transplantation</arm_group_label>
    <description>Women with end-stage renal disease, whose eligibility for renal transplantation is assessed</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of women above 18 years of age with end stage renal disease&#xD;
        who are registered for renal transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female sex;&#xD;
&#xD;
          -  Age ≥ 18 years at start of the study;&#xD;
&#xD;
          -  Eligible for renal transplantation;&#xD;
&#xD;
          -  Operation at the Radboud University Nijmegen Medical Centre;&#xD;
&#xD;
          -  Signed informed consent;&#xD;
&#xD;
          -  Mentally capable to understand and comprehend the study and its implications;&#xD;
&#xD;
          -  Sufficient knowledge of the Dutch language to read, fully understand and complete the&#xD;
             Questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not willing to sign and/or return the informed consent form;&#xD;
&#xD;
          -  Patient refusing additional treatment in case of abnormal findings at the first visit;&#xD;
&#xD;
          -  Patient being pregnant, or within a period of 3 months after delivery;&#xD;
&#xD;
          -  Patient being within a period of 3 months after miscarriage.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanne A de Hullu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Centre Nijmegen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboud University Nijmegen Medical Centre</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 24, 2016</last_update_submitted>
  <last_update_submitted_qc>October 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Nijmegen</investigator_affiliation>
    <investigator_full_name>Joanne A. de Hullu, MD, PhD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Human Papillomavirus</keyword>
  <keyword>Renal transplantation</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>
  </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/NCT01717443
org study id: NL38266.091.11
nct id: NCT01717443
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to examine the prevalence, incidence and genotype of anogenital
      HPV infections in women before and after renal transplantation. With this information the
      investigators can determine the value of vaccination in patients waiting for renal
      transplantation in the future.
Each year about 800 renal transplantations are performed in the Netherlands. The current
      immunosuppressive strategies have led to a 1-year patient and graft survival of more than
      90%. This high survival rate urges medical specialists to pay increasing attention to the
      long-term side effects of immunosuppressive medication, such as virus-associated cancers. An
      example of an oncogenic virus is the high risk Human Papillomavirus (hrHPV) which is related
      to (pre)malignancies of the anogenital tract e.g. cervix, vulva and anus. These malignancies
      are among the most common malignancies in renal transplant recipients (RTRs). The incidence
      of hrHPV-related cervical and vulvar malignancies is increased up to a 100-fold in RTRs
      compared to the general population. There is limited literature on the exact behaviour of HPV
      infection related anogenital (pre)malignancies in RTRs. A part of these (pre)malignancies are
      probably already present at the time of transplantation while others develop in the years
      after transplantation. With gynaecological examination the investigators can diagnose
      anogenital (pre)malignancies before transplantation so treatment, if necessary, can commence
      before transplantation. Knowledge about HPV status before and after transplantation gives
      insight in the natural course of the HPV infection in this group of patients and with this
      information the investigators can determine the value of vaccination in patients waiting for
      renal transplantation in the future.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of genital HPV infection before and after renal transplantation in women with end stage renal disease
time frame: 6 months before and 6 months after renal transplantation
description: The difference between post-transplantation prevalence (two HPV tests in 6 months after transplantation)and pre-transplantation prevalence (two HPV tests in 6 months before transplantation) will be compared.
measure: Incidence of genital HPV infection before and after renal transplantation
time frame: Assessed every 3 months for 2 years
measure: Genotype of the HPV infection per time point
time frame: Assessed every 3 months for 2 years
arm group label: Women, renal disease, transplantation
description: Women with end-stage renal disease, whose eligibility for renal transplantation is assessed
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joanne A de Hullu, MD, PhD
role: Principal Investigator
affiliation: University Medical Centre Nijmegen
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Nijmegen
investigator full name: Joanne A. de Hullu, MD, PhD
investigator title: MD, PhD
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Papillomavirus Infections