<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/NCT03777397</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL18_0769</org_study_id>
    <nct_id>NCT03777397</nct_id>
  </id_info>
  <brief_title>Awareness About Breast Cancer Screening</brief_title>
  <acronym>DEPSEIN_HCL</acronym>
  <official_title>Study of Awareness of Hospices Civils de Lyon Workers About Breast Cancer Screening</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>
      Breast cancer is the most common cancer in French women, with 52000 new cases each year.&#xD;
&#xD;
      Shift work and night work is recognized by International Agency for Research on Cancer as a&#xD;
      potential risk factor. Epidemiological studies find, for most of them, an increased risk of&#xD;
      breast cancer compared with general population. Physiological hypothesis rely on the&#xD;
      melatonin role in defense against tumorigenesis.&#xD;
&#xD;
      According to High Authority of Health clinical good practice guidelines, the risk does not&#xD;
      justify more screening than the organized screening. We do not have information about&#xD;
      awareness level of workers in health structures, specially in the Hospices Civils de Lyon.&#xD;
&#xD;
      Investigators would like to know how employees take part to breast cancer screening,&#xD;
      specially in night workers.&#xD;
&#xD;
      This study, as a survey, is a first step to evaluate the need for specific actions to&#xD;
      increase the participation to breast cancer screening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Actual">February 7, 2019</completion_date>
  <primary_completion_date type="Actual">February 7, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Participation of HCL female staff in mammography screening for breast cancer</measure>
    <time_frame>5 minutes</time_frame>
    <description>One question of the questionnaire is about this participation</description>
  </primary_outcome>
  <enrollment type="Actual">2264</enrollment>
  <condition>Breast Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Questionnaire on the level of awareness of this risk among health sector employees, and more specifically the Lyon Civilian Hospices, and on participation in breast cancer screening for HCL employees, particularly among night shift staff.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women employees of Hospices Civils de Lyon&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  employees HCL&#xD;
&#xD;
          -  women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years old&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Service de Gynécologie - Hôpital de la Croix-Rousse - Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>September 19, 2019</last_update_submitted>
  <last_update_submitted_qc>September 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2019</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>Breast Neoplasms</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/NCT03777397
org study id: 69HCL18_0769
nct id: NCT03777397
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Breast cancer is the most common cancer in French women, with 52000 new cases each year.

      Shift work and night work is recognized by International Agency for Research on Cancer as a
      potential risk factor. Epidemiological studies find, for most of them, an increased risk of
      breast cancer compared with general population. Physiological hypothesis rely on the
      melatonin role in defense against tumorigenesis.

      According to High Authority of Health clinical good practice guidelines, the risk does not
      justify more screening than the organized screening. We do not have information about
      awareness level of workers in health structures, specially in the Hospices Civils de Lyon.

      Investigators would like to know how employees take part to breast cancer screening,
      specially in night workers.

      This study, as a survey, is a first step to evaluate the need for specific actions to
      increase the participation to breast cancer screening.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Participation of HCL female staff in mammography screening for breast cancer
time frame: 5 minutes
description: One question of the questionnaire is about this participation
intervention type: Other
intervention name: Questionnaire
description: Questionnaire on the level of awareness of this risk among health sector employees, and more specifically the Lyon Civilian Hospices, and on participation in breast cancer screening for HCL employees, particularly among night shift staff.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No