<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/NCT04457570</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0509</org_study_id>
    <nct_id>NCT04457570</nct_id>
  </id_info>
  <brief_title>Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer</brief_title>
  <acronym>ONCOVID-AURA</acronym>
  <official_title>ONCOVID-AURA: Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Context:&#xD;
&#xD;
      Based on currently available data, most of national health authorities and consensus expert&#xD;
      groups have written guidelines for the management of cancer patients in the context of COVID.&#xD;
      However, the preparation of these guidelines was limited by the scarcity of solid&#xD;
      epidemiological data. For example, the experts were uncomfortable to formulate precise&#xD;
      guidelines on which anti-cancer treatment should be interrupted or replaced, on which&#xD;
      patients, and how to adapt supportive drug prescriptions.&#xD;
&#xD;
      Objectives :&#xD;
&#xD;
        -  To measure the excess risk of mortality and morbidity of patients with a history of&#xD;
           cancer among patients hospitalized for a SARS-CoV-2 infection.&#xD;
&#xD;
        -  To identify factors associated with the risk of death and morbidity among patients with&#xD;
           cancer.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      Retrospective inclusion of n=200 cancer patients hospitalized for COVID and n=400 matched&#xD;
      (based on age, gender, and comorbidity) non-cancer patients hospitalized for COVID. Two&#xD;
      analyses will be performed (after the inclusion of n=100 and n=200 patients with cancer). A&#xD;
      logistic modeling of the odds ratio of death associated to the exposition factor (i.e.&#xD;
      cancer) and adjusted for the matching parameters (age, gender, comorbidities) will be&#xD;
      proposed.&#xD;
&#xD;
      We will then look for the factors (related to the patients, the cancer or the treatment) that&#xD;
      modify the odds radio.&#xD;
&#xD;
      Expected results:&#xD;
&#xD;
      The data generated will help the medical and scientific community to evaluate the increasing&#xD;
      risk of cancer patients infected by SARS-CoV-2 compared to the non-cancer population, to&#xD;
      identify patients at higher risk of severe infection, but also the anticancer treatments&#xD;
      associated with an increased risk of severe infections.&#xD;
&#xD;
      Impact:&#xD;
&#xD;
      These data will contribute to guide the future recommendations concerning cancer patient's&#xD;
      care in the context of the COVID-19 pandemic. There is a real risk that the SARS-CoV&#xD;
      epidemic, or other respiratory viruses epidemic, will become recurrent in the future. Thus,&#xD;
      it is of crucial importance for now and for the future to know which are the major factors&#xD;
      associated with severe infections&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">February 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mortality for SARS-CoV-2 infection</measure>
    <time_frame>30 days</time_frame>
    <description>mortality within 30 days after the hospitalization for the SARS-CoV-2 infection</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>COVID, Cancer</condition>
  <arm_group>
    <arm_group_label>exposed patients</arm_group_label>
    <description>The &quot;exposed patients&quot; are patients with cancer that are hospitalized in one of the participating centers for a SARS-CoV-2 infection. A patient will be considered as an &quot;exposed patient&quot; if he/she had a surgical procedure or a medical treatment for cancer in the past 5 years preceding the SARS-CoV-2 infection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control patients</arm_group_label>
    <description>The &quot;control patients &quot; are all of the patients without cancer that are hospitalized in one of the participating centers for a SARS-CoV-2 infection</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mortality</intervention_name>
    <description>To measure the excess risk of mortality of patients with a history of cancer among patients hospitalized for a SARS-CoV-2 infection</description>
    <arm_group_label>control patients</arm_group_label>
    <arm_group_label>exposed patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Two categories of patients will be defined: the &quot;exposed patients&quot; are patients with cancer&#xD;
        that are hospitalized in one of the participating centers for a SARS-CoV-2 infection. A&#xD;
        patient will be considered as an &quot;exposed patient&quot; if he/she had a surgical procedure or a&#xD;
        medical treatment for cancer in the past 5 years preceding the SARS-CoV-2 infection.&#xD;
&#xD;
        The &quot;control patients&quot; are all of the patients without cancer that are hospitalized in one&#xD;
        of the participating centers for a SARS-CoV-2 infection.&#xD;
&#xD;
        In both cohorts, a positive laboratory test (RT-PCR) proving the SARS-CoV-2 infection will&#xD;
        be mandatory.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  EXPOSED PATIENTS:&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Patients with a confirmed diagnosis of solid or hematologic cancer&#xD;
&#xD;
          -  Patients who received their last anticancer treatment (surgery, systemic treatments or&#xD;
             other localized treatment) in the past 5 years before SARS-CoV-2 infection&#xD;
&#xD;
          -  Positive laboratory test (RT-PCR) proving the SARS-CoV-2 infection&#xD;
&#xD;
          -  Patients hospitalized in one of the participating centers because of the SARS-CoV-2&#xD;
             infection&#xD;
&#xD;
          -  Patients who are not opposed in participating to the ONCOVID-AURA study&#xD;
&#xD;
        CONTROL PATIENTS:&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Patients who have no cancer (neither solid nor hematologic tumors) or patients who&#xD;
             received their last anticancer treatments more than five years before the SARS-CoV-2&#xD;
             infection&#xD;
&#xD;
          -  Positive laboratory test (RT-PCR) proving the SARS-CoV-2 infection&#xD;
&#xD;
          -  Patients hospitalized in one of the participating centers because of the SARS-CoV-2&#xD;
             infection&#xD;
&#xD;
          -  Patients who are not opposed in participating to the ONCOVID-AURA study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#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>PERRON Julien, MD</last_name>
    <phone>+33 (0)4 78 86 37 75</phone>
    <email>julien.peron@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>CALATTINI Sarah</last_name>
    <phone>+33 (0) 4 78 86 37 79</phone>
    <email>sara.calattini@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre de lutte contre le Cancer JEAN PERRIN</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PERRON Julien, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Uniersitaire de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BAY Jacques Olivier, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PEROL David, Pr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de la Loire Lucien Neurwirth</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>FOURNEL Pierre, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de St Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Botelho-Nevers Elisabeth, PR</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04457570
org study id: 69HCL20_0509
nct id: NCT04457570
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Context:

      Based on currently available data, most of national health authorities and consensus expert
      groups have written guidelines for the management of cancer patients in the context of COVID.
      However, the preparation of these guidelines was limited by the scarcity of solid
      epidemiological data. For example, the experts were uncomfortable to formulate precise
      guidelines on which anti-cancer treatment should be interrupted or replaced, on which
      patients, and how to adapt supportive drug prescriptions.

      Objectives :

        -  To measure the excess risk of mortality and morbidity of patients with a history of
           cancer among patients hospitalized for a SARS-CoV-2 infection.

        -  To identify factors associated with the risk of death and morbidity among patients with
           cancer.

      Methodology:

      Retrospective inclusion of n=200 cancer patients hospitalized for COVID and n=400 matched
      (based on age, gender, and comorbidity) non-cancer patients hospitalized for COVID. Two
      analyses will be performed (after the inclusion of n=100 and n=200 patients with cancer). A
      logistic modeling of the odds ratio of death associated to the exposition factor (i.e.
      cancer) and adjusted for the matching parameters (age, gender, comorbidities) will be
      proposed.

      We will then look for the factors (related to the patients, the cancer or the treatment) that
      modify the odds radio.

      Expected results:

      The data generated will help the medical and scientific community to evaluate the increasing
      risk of cancer patients infected by SARS-CoV-2 compared to the non-cancer population, to
      identify patients at higher risk of severe infection, but also the anticancer treatments
      associated with an increased risk of severe infections.

      Impact:

      These data will contribute to guide the future recommendations concerning cancer patient's
      care in the context of the COVID-19 pandemic. There is a real risk that the SARS-CoV
      epidemic, or other respiratory viruses epidemic, will become recurrent in the future. Thus,
      it is of crucial importance for now and for the future to know which are the major factors
      associated with severe infections
observational model: Case-Control
time perspective: Retrospective
measure: mortality for SARS-CoV-2 infection
time frame: 30 days
description: mortality within 30 days after the hospitalization for the SARS-CoV-2 infection
arm group label: exposed patients
description: The "exposed patients" are patients with cancer that are hospitalized in one of the participating centers for a SARS-CoV-2 infection. A patient will be considered as an "exposed patient" if he/she had a surgical procedure or a medical treatment for cancer in the past 5 years preceding the SARS-CoV-2 infection.
arm group label: control patients
description: The "control patients " are all of the patients without cancer that are hospitalized in one of the participating centers for a SARS-CoV-2 infection
intervention type: Other
intervention name: mortality
description: To measure the excess risk of mortality of patients with a history of cancer among patients hospitalized for a SARS-CoV-2 infection
arm group label: control patients
arm group label: exposed patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: PERRON Julien, MD
phone: +33 (0)4 78 86 37 75
email: julien.peron@chu-lyon.fr
last name: CALATTINI Sarah
phone: +33 (0) 4 78 86 37 79
email: sara.calattini@chu-lyon.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided