<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/NCT03265743</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0277</org_study_id>
    <nct_id>NCT03265743</nct_id>
  </id_info>
  <brief_title>HPV Vaccination in Women With Cystic Fibrosis</brief_title>
  <acronym>VACCIN-HPV-MUC</acronym>
  <official_title>HPV (Papilloma Human Virus) Vaccination in Young Women With Cystic Fibrosis and Followed in the Auvergne Rhône-Alpes Region</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main risk factor for the development of cervical lesions is human papillomavirus (HPV)&#xD;
      infection. Vaccination against human papillomavirus, which is offered to all girls aged 11 to&#xD;
      14, and catching up to girls aged 15 to 19, is an effective method of preventing cervical&#xD;
      pathology. Despite this, human papillomavirus vaccination coverage remains low in France.&#xD;
&#xD;
      Some women with cystic fibrosis might need a transplantation, which is a factor associated&#xD;
      with increased risk of human papillomavirus carriage and cervical pathology. An over-risk of&#xD;
      cervical pathology would also be present in non-transplanted women with cystic fibrosis.&#xD;
      Particular attention should therefore be paid to vaccination in this population.&#xD;
&#xD;
      The objective is to estimate the frequency of human papillomavirus vaccination in young&#xD;
      patients with cystic fibrosis, and to evaluate the reasons for non-vaccination.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Realization of human papillomavirus vaccination</measure>
    <time_frame>15 minutes</time_frame>
    <description>The main outcome is the prevalence of human papillomavirus vaccination in young women with Cystic fibrosis.&#xD;
This data is collected using a questionnaire : HPV vaccination performed : yes/no</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of vaccine used</measure>
    <time_frame>15 minutes</time_frame>
    <description>This data is collected using a questionnaire : bivalent (Cervarix®) or quadrivalent (Gardasil®)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respect for the vaccinal plan</measure>
    <time_frame>15 minutes</time_frame>
    <description>This data is collected using a questionnaire : number and dates of injections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for non-vaccination</measure>
    <time_frame>15 minutes</time_frame>
    <description>In case of non-vaccination reasons are collected using a multiple choices questionnaire</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">74</enrollment>
  <condition>Human Papillomavirus Infection</condition>
  <arm_group>
    <arm_group_label>Patients with Cystic Fibrosis</arm_group_label>
    <description>Patients with Cystic Fibrosis, followed in a pediatric or mixed Cystic Fibrosis center of the region Auvergne Rhône Alpes (AuRA), aged 11 years or older.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-report Written Questionnaire</intervention_name>
    <description>Informations are gathered through a self-report written questionnaire, completed by the patients or their parents.</description>
    <arm_group_label>Patients with Cystic Fibrosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study is intended for girls with Cystic Fibrosis, followed in a pediatric or mixed&#xD;
        Cystic Fibrosis center of the region Auvergne Rhône Alpes (AuRA), aged 11 years or older.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  girls with Cystic Fibrosis&#xD;
&#xD;
          -  followed in a pediatric or mixed Cystic Fibrosis center of the region Auvergne Rhône&#xD;
             Alpes (AuRA)&#xD;
&#xD;
          -  aged 11 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Refusal to respond to the questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Nouvel Hôpital d'Estaing CRCM Mixte</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cystic Fibrosis Reference Center, Hospices Civils de Lyon</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>February 14, 2018</last_update_submitted>
  <last_update_submitted_qc>February 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papillomavirus Infections</mesh_term>
    <mesh_term>Cystic Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03265743
org study id: 69HCL17_0277
nct id: NCT03265743
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main risk factor for the development of cervical lesions is human papillomavirus (HPV)
      infection. Vaccination against human papillomavirus, which is offered to all girls aged 11 to
      14, and catching up to girls aged 15 to 19, is an effective method of preventing cervical
      pathology. Despite this, human papillomavirus vaccination coverage remains low in France.

      Some women with cystic fibrosis might need a transplantation, which is a factor associated
      with increased risk of human papillomavirus carriage and cervical pathology. An over-risk of
      cervical pathology would also be present in non-transplanted women with cystic fibrosis.
      Particular attention should therefore be paid to vaccination in this population.

      The objective is to estimate the frequency of human papillomavirus vaccination in young
      patients with cystic fibrosis, and to evaluate the reasons for non-vaccination.
observational model: Other
time perspective: Prospective
measure: Realization of human papillomavirus vaccination
time frame: 15 minutes
description: The main outcome is the prevalence of human papillomavirus vaccination in young women with Cystic fibrosis.
This data is collected using a questionnaire : HPV vaccination performed : yes/no
measure: Type of vaccine used
time frame: 15 minutes
description: This data is collected using a questionnaire : bivalent (Cervarix®) or quadrivalent (Gardasil®)
measure: Respect for the vaccinal plan
time frame: 15 minutes
description: This data is collected using a questionnaire : number and dates of injections
measure: Reasons for non-vaccination
time frame: 15 minutes
description: In case of non-vaccination reasons are collected using a multiple choices questionnaire
arm group label: Patients with Cystic Fibrosis
description: Patients with Cystic Fibrosis, followed in a pediatric or mixed Cystic Fibrosis center of the region Auvergne Rhône Alpes (AuRA), aged 11 years or older.
intervention type: Other
intervention name: Self-report Written Questionnaire
description: Informations are gathered through a self-report written questionnaire, completed by the patients or their parents.
arm group label: Patients with Cystic Fibrosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 11 Years
maximum age: 18 Years
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Papillomavirus Infections
mesh term: Cystic Fibrosis
sharing ipd: No