xml: <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/NCT06006845</url>
    </required_header>
    <id_info>
      <org_study_id>pan-01</org_study_id>
      <nct_id>NCT06006845</nct_id>
    </id_info>
    <brief_title>Time to Initiated Antitumor Therapy for Tumor Patients With COVID19 Infection</brief_title>
    <official_title>When to Initiation Antitumor Therapy for Tumor Patients With COVID19 Infection</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Seventh Affiliated Hospital of Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Seventh Affiliated Hospital of Sun Yat-sen University</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 goal of this observational study is to study the safety of initiation of antitumor&#xD;
        therapy early after nucleic acid test turn negativity in tumor patients infected with&#xD;
        COVID-19. The main questions aims to answer are:&#xD;
  &#xD;
          -  Whether initiation of antitumor therapy early after nucleic acid test turn negativity in&#xD;
             tumor patients infected with COVID-19 increases adverse events related to antitumor&#xD;
             therapy.&#xD;
  &#xD;
          -  Whether initiation of antitumor therapy early after nucleic acid test turn negativity in&#xD;
             tumor patients infected with COVID-19 increases risk of re-infection of COVID-19.&#xD;
  &#xD;
          -  How initiation of antitumor therapy early after nucleic acid test turn negativity in&#xD;
             tumor patients infected with COVID-19 affects QoL of tumor patients&#xD;
  &#xD;
        Participants will be asked to answer the question about:&#xD;
  &#xD;
          -  the severity and duration of COVID-19 symptoms&#xD;
  &#xD;
          -  the date of diagnosis of COVID-19&#xD;
  &#xD;
          -  the date of negative nucleic acid test&#xD;
  &#xD;
          -  the QoL of life before infection with COVID-19, during infection of COVID-19, after&#xD;
             nucleic acid test negativity and receiving antitumor therapy&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Actual">February 1, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of adverse events after antitumor therapy</measure>
      <time_frame>28 days after antitumor therapy</time_frame>
      <description>Incidence of adverse events after antitumor therapy, including hematologic toxicity,gastrointestinal adverse event, hepatobiliary adverse events, etc.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Re-infection of COVID-19</measure>
      <time_frame>28 days after antitumor therapy</time_frame>
      <description>Antigen testing or nucleic acid testing positive for COVID-19</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical manifestations of COVID-19 in tumor patients</measure>
      <time_frame>Until nucleic acid testing turn negative</time_frame>
      <description>Symptoms and lab abnormality of COVID-19 in tumor patients</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Tumor</condition>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>A</arm_group_label>
      <description>Tumor patients infected with COVID-19</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Tumor patients infected with COVID-19 from December 1, 2022 to May 31, and received&#xD;
          systemic antitumor therapy after infected with COVID-19.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Tumor patients diagnosed with COVID-19 infection at our center from December 1, 2022&#xD;
               to May 31.&#xD;
  &#xD;
            -  COVID-19 was confirmed by antigen testing or nucleic acid testing.&#xD;
  &#xD;
            -  Tumor was confirmed by pathology.&#xD;
  &#xD;
            -  Patients received systemic antitumor therapy after infected with COVID-19.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  COVID-19 was not confirmed by antigen testing or nucleic acid testing&#xD;
  &#xD;
            -  Tumor was not confirmed by pathology&#xD;
  &#xD;
            -  Patients did not receive systemic antitumor therapy&#xD;
  &#xD;
            -  Patients died before receiving systemic antitumor therapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bo Wang</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Seventh Affiliated Hospital of Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaofen Pan, MD</last_name>
      <phone>+8618124671750</phone>
      <email>panxf8@mail.sysu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bo Wang, MD</last_name>
      <phone>0755-81206796</phone>
      <email>wangb68377@sina.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Seventh Affiliated Hospital, Sun Yat-sen University</name>
        <address>
          <city>Shenzhen</city>
          <state>Guangdong</state>
          <zip>518107</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaofen Pan, MD</last_name>
        <phone>+8618124671750</phone>
        <email>panxf8@mail.sysu.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Bo Wang, MD</last_name>
        <phone>0755-81206796</phone>
        <email>wangb68377@sina.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Seventh Affiliated Hospital of Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Wang Bo</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Tumor patients</keyword>
    <keyword>COVID-19</keyword>
    <keyword>antitumor therapy</keyword>
    <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>
  
  
text: 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/NCT06006845
  org study id: pan-01
  nct id: NCT06006845
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to study the safety of initiation of antitumor
        therapy early after nucleic acid test turn negativity in tumor patients infected with
        COVID-19. The main questions aims to answer are:
  
          -  Whether initiation of antitumor therapy early after nucleic acid test turn negativity in
             tumor patients infected with COVID-19 increases adverse events related to antitumor
             therapy.
  
          -  Whether initiation of antitumor therapy early after nucleic acid test turn negativity in
             tumor patients infected with COVID-19 increases risk of re-infection of COVID-19.
  
          -  How initiation of antitumor therapy early after nucleic acid test turn negativity in
             tumor patients infected with COVID-19 affects QoL of tumor patients
  
        Participants will be asked to answer the question about:
  
          -  the severity and duration of COVID-19 symptoms
  
          -  the date of diagnosis of COVID-19
  
          -  the date of negative nucleic acid test
  
          -  the QoL of life before infection with COVID-19, during infection of COVID-19, after
             nucleic acid test negativity and receiving antitumor therapy
  observational model: Cohort
  time perspective: Retrospective
  measure: Incidence of adverse events after antitumor therapy
  time frame: 28 days after antitumor therapy
  description: Incidence of adverse events after antitumor therapy, including hematologic toxicity,gastrointestinal adverse event, hepatobiliary adverse events, etc.
  measure: Re-infection of COVID-19
  time frame: 28 days after antitumor therapy
  description: Antigen testing or nucleic acid testing positive for COVID-19
  measure: Clinical manifestations of COVID-19 in tumor patients
  time frame: Until nucleic acid testing turn negative
  description: Symptoms and lab abnormality of COVID-19 in tumor patients
  arm group label: A
  description: Tumor patients infected with COVID-19
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Bo Wang
  role: Principal Investigator
  affiliation: The Seventh Affiliated Hospital of Sun Yat-sen University
  last name: Xiaofen Pan, MD
  phone: +8618124671750
  email: panxf8@mail.sysu.edu.cn
  last name: Bo Wang, MD
  phone: 0755-81206796
  email: wangb68377@sina.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: The Seventh Affiliated Hospital of Sun Yat-sen University
  investigator full name: Wang Bo
  investigator title: Professor
  mesh term: COVID-19