<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/NCT02255084</url>
  </required_header>
  <id_info>
    <org_study_id>INCA13-KH / APACHE-3</org_study_id>
    <nct_id>NCT02255084</nct_id>
  </id_info>
  <brief_title>Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women</brief_title>
  <acronym>APACHE-3</acronym>
  <official_title>Attitude of Unscreened Women Face to Different Strategies to Participate in Cervical Cancer Screening by Vaginal Self-sampling : Home-mailed or Invitation to Remove to Their General Practitioner</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the existence of an effective screening test (pap smear), cervical cancer is, every&#xD;
      year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in&#xD;
      10 women are not screened or not often enough (nearly 7 millions women). It is therefore&#xD;
      necessary to develop new strategies to reach these women. The etiological factor of this&#xD;
      cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV).&#xD;
      Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with&#xD;
      HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal&#xD;
      self-sampling with HPV test is a powerful means to increase the participation rate in&#xD;
      cervical cancer screening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participation / no participation to complete cervical cancer screening</measure>
    <time_frame>9 months after postal mail</time_frame>
    <description>Uncompleted cervical cancer screening is defined as one of the followings :&#xD;
no pap smear&#xD;
no vaginal self-sampling&#xD;
noninterpretable HPV test result and no pap smear&#xD;
positive HPV test result and no control pap smear</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3612</enrollment>
  <condition>Cancer Cervix</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 remove self sample kit at gp consulting room or perform pap smear :&#xD;
Study coordinators send mail inviting women to remove a kit for vaginal self-sampling at their general practitioner s consulting room.&#xD;
Either a pap smear is perform or, at home, women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2 perform self sample at home or pap smear :&#xD;
Kit for vaginal self-sampling sent at women home. Women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group 1 remove self sample kit at gp consulting room or perform pap smear</intervention_name>
    <description>Selected general practitioners are briefly informed about the study and they receive a package of kits for vaginal self-sampling.&#xD;
Selected women receive a mail inviting them either to remove a kit for vaginal self-sampling at their general practitioner's consulting room or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group 2 perform self sample at home or pap smear</intervention_name>
    <description>Selected general practitioners are briefly informed about the study. Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.&#xD;
When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women from 30 to 65 years old&#xD;
&#xD;
          -  women living in french territorial division 37 (&quot;Indre-et-Loire&quot;)&#xD;
&#xD;
          -  women having a reported general practitioner in french territorial division 37&#xD;
             (&quot;Indre-et-Loire&quot;)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pap smear made in the three last years&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ken HAGUENOER, MD-PHD</last_name>
    <role>Study Director</role>
    <affiliation>Centre de coordination des dépistages des cancers, Tours, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Somany SENGCHANH, MD-PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de coordination des dépistages des cancers, Tours, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UH Tours</name>
      <address>
        <city>Tours</city>
        <state>Indre et Loire</state>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>October 25, 2016</last_update_submitted>
  <last_update_submitted_qc>October 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cervical cancer screening</keyword>
  <keyword>High Risk Human papillomavirus Infection</keyword>
  <keyword>vaginal self-sampling</keyword>
  <keyword>pap smear</keyword>
  <keyword>general practitioner</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menthol</mesh_term>
  </intervention_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/NCT02255084
org study id: INCA13-KH / APACHE-3
nct id: NCT02255084
lead sponsor: 
has dmc: No
Despite the existence of an effective screening test (pap smear), cervical cancer is, every
      year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in
      10 women are not screened or not often enough (nearly 7 millions women). It is therefore
      necessary to develop new strategies to reach these women. The etiological factor of this
      cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV).
      Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with
      HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal
      self-sampling with HPV test is a powerful means to increase the participation rate in
      cervical cancer screening.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Participation / no participation to complete cervical cancer screening
time frame: 9 months after postal mail
description: Uncompleted cervical cancer screening is defined as one of the followings :
no pap smear
no vaginal self-sampling
noninterpretable HPV test result and no pap smear
positive HPV test result and no control pap smear
arm group label: Group 1
arm group type: Experimental
description: Group 1 remove self sample kit at gp consulting room or perform pap smear :
Study coordinators send mail inviting women to remove a kit for vaginal self-sampling at their general practitioner s consulting room.
Either a pap smear is perform or, at home, women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus).
arm group label: Group 2
arm group type: Experimental
description: Group 2 perform self sample at home or pap smear :
Kit for vaginal self-sampling sent at women home. Women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus).
intervention type: Behavioral
intervention name: Group 1 remove self sample kit at gp consulting room or perform pap smear
description: Selected general practitioners are briefly informed about the study and they receive a package of kits for vaginal self-sampling.
Selected women receive a mail inviting them either to remove a kit for vaginal self-sampling at their general practitioner's consulting room or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.
arm group label: Group 1
intervention type: Behavioral
intervention name: Group 2 perform self sample at home or pap smear
description: Selected general practitioners are briefly informed about the study. Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.
When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.
arm group label: Group 2
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ken HAGUENOER, MD-PHD
role: Study Director
affiliation: Centre de coordination des dépistages des cancers, Tours, France
last name: Somany SENGCHANH, MD-PHD
role: Principal Investigator
affiliation: Centre de coordination des dépistages des cancers, Tours, France
facility: 
country: France
responsible party type: Sponsor
mesh term: Menthol