<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/NCT04476823</url>
  </required_header>
  <id_info>
    <org_study_id>20labocovid01</org_study_id>
    <nct_id>NCT04476823</nct_id>
  </id_info>
  <brief_title>European Pathology Laboratories and COVID-19</brief_title>
  <official_title>Practice in Clinical and Molecular Thoracic European Pathology Laboratories During the COVID-19 Pandemic.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), notably when&#xD;
      handling human samples, remains poorly understood, as well as the impact of the COVID-19&#xD;
      pandemic in routine clinical and molecular pathology practice, and for personal working in&#xD;
      pathology laboratories. This study evaluates the consequences of the COVID-19 crisis in&#xD;
      clinical and molecular pathology laboratories in Europe mostly those orientated for diagnosis&#xD;
      of thoracic diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2020</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</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>Activity</measure>
    <time_frame>1 day</time_frame>
    <description>The activity of the pathology laboratories has been compared for a same period (from the 15th of March 15 to the 31th of May) in 2019 and in 2020</description>
  </primary_outcome>
  <enrollment type="Actual">71</enrollment>
  <condition>Clinical Practice During the COVID-19 Crisis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Activity</intervention_name>
    <description>The questionnaire had requested information on the biosafety organization, impact of the COVID-19 crisis on the clinical and molecular pathology and the biobanking activity in thoracic pathology, on the research activity associated with the COVID-19, and on the educational and training organization. It requested the different needs planned by the different laboratories following the COVID-19 crisis and finally the consequence of this latter on the health and virological status of the staff members.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pathology laboratories belonging to the Lung working group of the European Society of&#xD;
        Pathology and to additional European pathology laboratories expert in thoracic diseases&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  laboratories following the COVID-19 crisis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06001</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</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>COVID-19</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/NCT04476823
org study id: 20labocovid01
nct id: NCT04476823
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), notably when
      handling human samples, remains poorly understood, as well as the impact of the COVID-19
      pandemic in routine clinical and molecular pathology practice, and for personal working in
      pathology laboratories. This study evaluates the consequences of the COVID-19 crisis in
      clinical and molecular pathology laboratories in Europe mostly those orientated for diagnosis
      of thoracic diseases.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Activity
time frame: 1 day
description: The activity of the pathology laboratories has been compared for a same period (from the 15th of March 15 to the 31th of May) in 2019 and in 2020
intervention type: Other
intervention name: Activity
description: The questionnaire had requested information on the biosafety organization, impact of the COVID-19 crisis on the clinical and molecular pathology and the biobanking activity in thoracic pathology, on the research activity associated with the COVID-19, and on the educational and training organization. It requested the different needs planned by the different laboratories following the COVID-19 crisis and finally the consequence of this latter on the health and virological status of the staff members.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19