<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/NCT03018327</url>
  </required_header>
  <id_info>
    <org_study_id>H-15014510</org_study_id>
    <nct_id>NCT03018327</nct_id>
  </id_info>
  <brief_title>Ano-genital Human Papillomavirus (HPV) Infection, Precancerous Lesions and Genital Warts Among Danish Renal Transplant Recipients</brief_title>
  <official_title>Ano-genital Human Papillomavirus (HPV) Infection, Genital Warts, Precancerous Lesions and Cancer Among Danish Renal Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danish Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transplant-related malignancies have emerged as one of the important complications after&#xD;
      organ transplantation. Some studies have shown that transplant recipients have an increased&#xD;
      risk of developing cancer, especially non-melanoma skin cancer. Because of iatrogenic&#xD;
      immunosuppression in these patients, there is an increasing focus on human papillomavirus&#xD;
      (HPV) related cancers.&#xD;
&#xD;
      The occurrence of HPV infection and ano-genital precancerous lesions and genital warts among&#xD;
      Danish renal transplant recipients (RTRs) is not known. Relatively few controlled studies&#xD;
      exist on the prevalence of ano-genital HPV infection, anal precancerous lesions and cervical&#xD;
      precancerous lesions among RTRs.&#xD;
&#xD;
      Knowledge about HPV infection and HPV-related ano-genital precancerous lesions in renal&#xD;
      transplant recipients, together with identification of factors that play a role for&#xD;
      development of anal and cervical precancerous lesions, is important for the possibility of&#xD;
      early detection and treatment to prevent progression to ano-genital cancers. Cervical&#xD;
      cytology has been used for decades to detect cervical intra-epithelial neoplasia (CIN),&#xD;
      whereas high-resolution anoscopy is a newer modality for the detection of anal&#xD;
      intra-epithelial neoplasia (AIN). International guidelines recommend annually screening&#xD;
      against cervical cancer for female renal transplant recipients, but currently no&#xD;
      recommendation exists on screening against anal cancer.&#xD;
&#xD;
      Aim: In a clinical study it is the aim to examine the prevalence of anal, penile, oral and&#xD;
      cervical HPV infection as well as ano-genital dysplasia and ano-genital warts among 250 renal&#xD;
      transplant recipients and an immunocompetent control group. Furthermore to identify factors&#xD;
      associated with the development of AIN or CIN such as HPV type, viral load, duration of&#xD;
      immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking&#xD;
      and alcohol habits, history of genital warts and other infections, and socio-economic&#xD;
      variables.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 7, 2016</start_date>
  <completion_date type="Actual">September 6, 2017</completion_date>
  <primary_completion_date type="Actual">September 6, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of ano-genital HPV infection, dysplasia and warts</measure>
    <time_frame>18 month</time_frame>
    <description>Prevalence of oral, penile, cervical and anal HPV infection, ano-genital dysplasia and warts</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors for the development of ano-genital dysplasia and warts</measure>
    <time_frame>18 month</time_frame>
    <description>Identifying factors associated with the development of AIN or CIN such as HPV type, viral load, duration of immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking and alcohol habits, history of genital warts and other infections, and socio-economic variables.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Anogenital Dysplasia</condition>
  <arm_group>
    <arm_group_label>Case group</arm_group_label>
    <description>250 Renal Transplant Recipients; 125 women and 125 men</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>250 healthy controls; 125 women and 125 men</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      HPV samples tested by Inno-lipa&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We will include 250 male and female renal transplant recipients in the case group. The&#xD;
        patients will be recruited from &quot;The Transplantation Clinic&quot; at the Department of&#xD;
        Dermato-venereology, Bispebjerg Hospital (BBH), where they are being followed for&#xD;
        development of cutaneous (pre-)malignancies and from the Department of Nephrology at&#xD;
        Rigshospital and Herlev Hospital, Denmark. In the control group we will include 250&#xD;
        immunocompetent individuals consisting of male and female patients coming for control of&#xD;
        birthmarks at the Nevus Clinic or Non-melanoma skin cancer and precancer at BBH and&#xD;
        patients having laser treatment for benign cutaneous lesions at BBH. The participants will&#xD;
        be enrolled in the study after informed consent has been obtained.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Case group:&#xD;
&#xD;
          1. Renal transplant recipients men and women ≥ 18 years of age&#xD;
&#xD;
          2. ≥ 6 months posttransplantation&#xD;
&#xD;
          3. Stabile immunosuppressive regime&#xD;
&#xD;
          4. No signs of acute rejection og the transplant&#xD;
&#xD;
        Control group:&#xD;
&#xD;
        1. Health men and women ≥18years of age from the Nevus clinic, Laser clinic and&#xD;
        non-melanoma skin cancer clinic, Bispebjerg Hospital, Copenhagen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Case group:&#xD;
&#xD;
               1. Other known immunosuppression&#xD;
&#xD;
                  Both case- og control group:&#xD;
&#xD;
               2. Previous HPV vaccination&#xD;
&#xD;
               3. Previous total hysterectomy&#xD;
&#xD;
               4. Inflammatory bowel disease&#xD;
&#xD;
               5. HIV infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helle Kiellberg Larsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Dermato-venereology, Bispebjerg Hospital, 2400 Copenhagen, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Dermato-venereology, Bispebjerg Hospital</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 18, 2018</last_update_submitted>
  <last_update_submitted_qc>January 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Helle Kiellberg Larsen</investigator_full_name>
    <investigator_title>Staff specialist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03018327
org study id: H-15014510
nct id: NCT03018327
lead sponsor: 
collaborator: 
has dmc: Yes
Transplant-related malignancies have emerged as one of the important complications after
      organ transplantation. Some studies have shown that transplant recipients have an increased
      risk of developing cancer, especially non-melanoma skin cancer. Because of iatrogenic
      immunosuppression in these patients, there is an increasing focus on human papillomavirus
      (HPV) related cancers.

      The occurrence of HPV infection and ano-genital precancerous lesions and genital warts among
      Danish renal transplant recipients (RTRs) is not known. Relatively few controlled studies
      exist on the prevalence of ano-genital HPV infection, anal precancerous lesions and cervical
      precancerous lesions among RTRs.

      Knowledge about HPV infection and HPV-related ano-genital precancerous lesions in renal
      transplant recipients, together with identification of factors that play a role for
      development of anal and cervical precancerous lesions, is important for the possibility of
      early detection and treatment to prevent progression to ano-genital cancers. Cervical
      cytology has been used for decades to detect cervical intra-epithelial neoplasia (CIN),
      whereas high-resolution anoscopy is a newer modality for the detection of anal
      intra-epithelial neoplasia (AIN). International guidelines recommend annually screening
      against cervical cancer for female renal transplant recipients, but currently no
      recommendation exists on screening against anal cancer.

      Aim: In a clinical study it is the aim to examine the prevalence of anal, penile, oral and
      cervical HPV infection as well as ano-genital dysplasia and ano-genital warts among 250 renal
      transplant recipients and an immunocompetent control group. Furthermore to identify factors
      associated with the development of AIN or CIN such as HPV type, viral load, duration of
      immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking
      and alcohol habits, history of genital warts and other infections, and socio-economic
      variables.
observational model: Case-Control
time perspective: Prospective
measure: Prevalence of ano-genital HPV infection, dysplasia and warts
time frame: 18 month
description: Prevalence of oral, penile, cervical and anal HPV infection, ano-genital dysplasia and warts
measure: Risk factors for the development of ano-genital dysplasia and warts
time frame: 18 month
description: Identifying factors associated with the development of AIN or CIN such as HPV type, viral load, duration of immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking and alcohol habits, history of genital warts and other infections, and socio-economic variables.
arm group label: Case group
description: 250 Renal Transplant Recipients; 125 women and 125 men
arm group label: Control group
description: 250 healthy controls; 125 women and 125 men
HPV samples tested by Inno-lipa
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Helle Kiellberg Larsen, MD
role: Principal Investigator
affiliation: Department of Dermato-venereology, Bispebjerg Hospital, 2400 Copenhagen, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Helle Kiellberg Larsen
investigator title: Staff specialist
mesh term: Condylomata Acuminata