<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/NCT04406571</url>
  </required_header>
  <id_info>
    <org_study_id>PO20042</org_study_id>
    <nct_id>NCT04406571</nct_id>
  </id_info>
  <brief_title>Reorganization of the Healthcare System During COVID-19 Pandemic: Impact on Management of Patients With Exocrine Pancreatic Cancer</brief_title>
  <acronym>CAPANCOVID-19</acronym>
  <official_title>Reorganization of the Healthcare System During COVID-19 Pandemic: Impact on Management of Patients With Exocrine Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Reims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Reims</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>
      Pancreatic adenocarcinoma will be the 2nd cause of death by cancer in Europe in 2030.&#xD;
      Pancreatic adenocarcinoma has poor prognosis with an all-stages combined 5-year survival rate&#xD;
      below 8%.&#xD;
&#xD;
      Since December 2019, a new coronavirus (Severe Acute Respiratory Syndrome Corona Virus 2,&#xD;
      SARS-CoV-2) is responsible of COVID-19 infection with potentially severe respiratory syndrome&#xD;
      or even multi-organ failure. An increased risk of severe COVID-19 infection in cancer&#xD;
      patients is suggested in several Chinese series. Cancer care structures quickly reorganized&#xD;
      to limit high-risk situations (diagnostic procedure, major surgery, cytotoxic&#xD;
      poly-chemotherapy) and use alternatives such as on-hold chemotherapy. These reorganizations&#xD;
      could be associated with a loss of chance for pancreatic adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to study impact of reorganization of the healthcare system during&#xD;
      COVID-19 pandemic on pancreatic adenocarcinoma patients management&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pancreatic adenocarcinoma treatment</measure>
    <time_frame>6 months</time_frame>
    <description>curative surgery (with or without chemotherapy), chemotherapy only or exclusive supportive care</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Pancreatic Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>&quot;pancreatic adenocarcinoma before COVID-19 containment &quot; group</arm_group_label>
    <description>patients with pancreatic adenocarcinoma assessed during multidisciplinary meeting in one participating center between 01/09/2019 and 16/03/2020.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;pancreatic adenocarcinoma after COVID-19 containment &quot; group</arm_group_label>
    <description>patients with pancreatic adenocarcinoma assessed during multidisciplinary meeting in one participating center between 17/03/2020 and 31/10/2020.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data record</intervention_name>
    <description>Data record</description>
    <arm_group_label>&quot;pancreatic adenocarcinoma after COVID-19 containment &quot; group</arm_group_label>
    <arm_group_label>&quot;pancreatic adenocarcinoma before COVID-19 containment &quot; group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with pancreatic adenocarcinoma diagnosed between 01/09/2019 and 31/10/2020.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          1. aged 18 or over,&#xD;
&#xD;
          2. with pancreatic adenocarcinoma diagnosed by anatomopathological specimen or without&#xD;
             biopsy but with suspicion of pancreatic adenocarcinoma in presence of imaging&#xD;
             techniques or Ca19.9 level without evidence for neuroendocrine tumor,&#xD;
&#xD;
          3. assessed during multidisciplinary meeting in one participating center between&#xD;
             01/09/2019 and 31/10/2020,&#xD;
&#xD;
          4. accepting to participate to the study,&#xD;
&#xD;
          5. with or without SARS-CoV-2 infection.&#xD;
&#xD;
        Exclusion criteria :&#xD;
&#xD;
          1. with neuroendocrine neoplasia&#xD;
&#xD;
          2. for whom histology showed non pancreatic&#xD;
&#xD;
          3. with cystadenoma or IPMN without invasive adenocarcinoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Olivier BOUCHE</last_name>
    <phone>03 26 78 31 13</phone>
    <email>obouche@chu-reims.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Damien JOLLY</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier BOUCHE</last_name>
      <phone>03 26 78 31 13</phone>
      <email>obouche@chu-reims.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pancreatic adenocarcinoma</keyword>
  <keyword>patient management</keyword>
  <keyword>healthcare system reorganization</keyword>
  <keyword>SARS-CoV-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Adenocarcinoma</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/NCT04406571
org study id: PO20042
nct id: NCT04406571
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pancreatic adenocarcinoma will be the 2nd cause of death by cancer in Europe in 2030.
      Pancreatic adenocarcinoma has poor prognosis with an all-stages combined 5-year survival rate
      below 8%.

      Since December 2019, a new coronavirus (Severe Acute Respiratory Syndrome Corona Virus 2,
      SARS-CoV-2) is responsible of COVID-19 infection with potentially severe respiratory syndrome
      or even multi-organ failure. An increased risk of severe COVID-19 infection in cancer
      patients is suggested in several Chinese series. Cancer care structures quickly reorganized
      to limit high-risk situations (diagnostic procedure, major surgery, cytotoxic
      poly-chemotherapy) and use alternatives such as on-hold chemotherapy. These reorganizations
      could be associated with a loss of chance for pancreatic adenocarcinoma.
The aim of this study is to study impact of reorganization of the healthcare system during
      COVID-19 pandemic on pancreatic adenocarcinoma patients management
observational model: Cohort
time perspective: Prospective
measure: Pancreatic adenocarcinoma treatment
time frame: 6 months
description: curative surgery (with or without chemotherapy), chemotherapy only or exclusive supportive care
arm group label: "pancreatic adenocarcinoma before COVID-19 containment " group
description: patients with pancreatic adenocarcinoma assessed during multidisciplinary meeting in one participating center between 01/09/2019 and 16/03/2020.
arm group label: "pancreatic adenocarcinoma after COVID-19 containment " group
description: patients with pancreatic adenocarcinoma assessed during multidisciplinary meeting in one participating center between 17/03/2020 and 31/10/2020.
intervention type: Other
intervention name: Data record
description: Data record
arm group label: "pancreatic adenocarcinoma after COVID-19 containment " group
arm group label: "pancreatic adenocarcinoma before COVID-19 containment " group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier BOUCHE
phone: 03 26 78 31 13
email: obouche@chu-reims.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Adenocarcinoma