<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/NCT04408339</url>
  </required_header>
  <id_info>
    <org_study_id>PV7313</org_study_id>
    <nct_id>NCT04408339</nct_id>
  </id_info>
  <brief_title>COVID-19 in Cancer Patients: Evaluation of Clinical Course and Impact on Oncological Care Including Biobanking</brief_title>
  <acronym>COVIDHELP</acronym>
  <official_title>COVID-19 Disease in Cancer Patients: Evaluation of Clinical Course and Impact on Oncological Care in the Hamburg Metropolitan Area Including Prospective Biobanking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hopsital Schleswig Holstein Campus Lübeck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universitätsklinikum Schleswig-Holstein, Campus Kiel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</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 COVIDHELP study will prospectively evaluate the yet unknown clinical course of the&#xD;
      COVID-19 infection in cancer patients and document the impact of potential infrastructural&#xD;
      limitations on cancer care of COVID-19 positive patients. All patients consenting will&#xD;
      provide peripheral blood samples for prospective biobanking with the aim of investigating&#xD;
      immune response and immunity against COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Based on patients, who are treated in the University Cancer Center Hamburg (UCCH) and its&#xD;
      contracted partner network, which comprises all cancer treating departments at the University&#xD;
      Medical Center of Hamburg-Eppendorf (UKE), as well as 19 office-based oncologists and 20&#xD;
      surrounding hospitals, recruitment for the study will be done as follows:&#xD;
&#xD;
      (i) as a cancer patient during regular aftercare appointments who reports a current or past&#xD;
      COVID-19 infection.&#xD;
&#xD;
      (ii) as an acute COVID-19 patient who reports a prevalent cancer diagnosis&#xD;
&#xD;
      Data will be collected as available from routine clinical care and includes demographic and&#xD;
      biometric data, medical history, baseline data at inclusion as well as inpatient and&#xD;
      intensive care unit admissions. Upon consent, patients will provide peripheral blood samples&#xD;
      at time of inclusion and after 6 month. Recruitment is limited to a one-year period (April&#xD;
      2020 - April 2021).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 15, 2020</start_date>
  <completion_date type="Anticipated">April 14, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 14, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Rate of hospitalization</measure>
    <time_frame>2 years</time_frame>
    <description>Measured in percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of hospitalization</measure>
    <time_frame>2 years</time_frame>
    <description>Measured in days from date of admission to definitive discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of admission to intensive care unit</measure>
    <time_frame>2 years</time_frame>
    <description>Measured in percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of stay in intensive care unit</measure>
    <time_frame>2 years</time_frame>
    <description>Measured in days from date of admission to intensive care unit to the date of discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Need of mechanical ventilation</measure>
    <time_frame>2 years</time_frame>
    <description>Measured in percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>2 years</time_frame>
    <description>Measured in days from the date of intubation to the stop date of mechanical ventilation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease-specific mortality rate</measure>
    <time_frame>2 years</time_frame>
    <description>COVID-19 associated mortality rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of patients, whose oncologic treatment had to be modified due to COVID-19</measure>
    <time_frame>2 years</time_frame>
    <description>Measured in percentage. Modification is defined as cancellation, postponement or dose-adjustment of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cellular and humoral immune response to COVID-19 infection</measure>
    <time_frame>6 month</time_frame>
    <description>Analysis of blood samples at time of diagnosis and after 6 month</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cancer</condition>
  <condition>COVID</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>No Intervention</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Peripheral Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Our study population consists of patients, who are treated in the University Cancer Center&#xD;
        Hamburg (UCCH) and its contracted partner network, who are either cancer patients reporting&#xD;
        a current or past COVID-19 infection, or acute COVID-19 patients who report a prevalent&#xD;
        cancer diagnosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Key inclusion criteria:&#xD;
&#xD;
          -  Known diagnosis of cancer&#xD;
&#xD;
          -  Known diagnosis of CoVID-19 infection&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Key exclusion criteria:&#xD;
&#xD;
        • refusal of participation&#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_official>
    <last_name>Katja Weisel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center of Hamburg-Eppendorf</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katja Weisel, MD</last_name>
    <phone>+49407410</phone>
    <phone_ext>58787</phone_ext>
    <email>k.weisel@uke.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Niklas Boerschel, MD</last_name>
    <phone>+49407410</phone>
    <phone_ext>51410</phone_ext>
    <email>n.boerschel@uke.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Hamburg Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>S Guengoer</last_name>
      <email>s.guengoer@uke.de</email>
    </contact>
    <investigator>
      <last_name>Katja Weisel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>June 14, 2020</last_update_submitted>
  <last_update_submitted_qc>June 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 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>Disease Progression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Aggregated data will be shared</ipd_description>
  </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/NCT04408339
org study id: PV7313
nct id: NCT04408339
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The COVIDHELP study will prospectively evaluate the yet unknown clinical course of the
      COVID-19 infection in cancer patients and document the impact of potential infrastructural
      limitations on cancer care of COVID-19 positive patients. All patients consenting will
      provide peripheral blood samples for prospective biobanking with the aim of investigating
      immune response and immunity against COVID-19.
Based on patients, who are treated in the University Cancer Center Hamburg (UCCH) and its
      contracted partner network, which comprises all cancer treating departments at the University
      Medical Center of Hamburg-Eppendorf (UKE), as well as 19 office-based oncologists and 20
      surrounding hospitals, recruitment for the study will be done as follows:

      (i) as a cancer patient during regular aftercare appointments who reports a current or past
      COVID-19 infection.

      (ii) as an acute COVID-19 patient who reports a prevalent cancer diagnosis

      Data will be collected as available from routine clinical care and includes demographic and
      biometric data, medical history, baseline data at inclusion as well as inpatient and
      intensive care unit admissions. Upon consent, patients will provide peripheral blood samples
      at time of inclusion and after 6 month. Recruitment is limited to a one-year period (April
      2020 - April 2021).
observational model: Cohort
time perspective: Prospective
measure: Rate of hospitalization
time frame: 2 years
description: Measured in percentage
measure: Duration of hospitalization
time frame: 2 years
description: Measured in days from date of admission to definitive discharge
measure: Rate of admission to intensive care unit
time frame: 2 years
description: Measured in percentage
measure: Length of stay in intensive care unit
time frame: 2 years
description: Measured in days from date of admission to intensive care unit to the date of discharge
measure: Need of mechanical ventilation
time frame: 2 years
description: Measured in percentage
measure: Duration of mechanical ventilation
time frame: 2 years
description: Measured in days from the date of intubation to the stop date of mechanical ventilation
measure: Disease-specific mortality rate
time frame: 2 years
description: COVID-19 associated mortality rate
measure: Rate of patients, whose oncologic treatment had to be modified due to COVID-19
time frame: 2 years
description: Measured in percentage. Modification is defined as cancellation, postponement or dose-adjustment of treatment.
measure: Cellular and humoral immune response to COVID-19 infection
time frame: 6 month
description: Analysis of blood samples at time of diagnosis and after 6 month
intervention type: Other
intervention name: No Intervention
description: No Intervention
Peripheral Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katja Weisel, MD
role: Principal Investigator
affiliation: University Medical Center of Hamburg-Eppendorf
last name: Katja Weisel, MD
phone: +49407410
phone ext: 58787
email: k.weisel@uke.de
last name: Niklas Boerschel, MD
phone: +49407410
phone ext: 51410
email: n.boerschel@uke.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Disease Progression
sharing ipd: Undecided
ipd description: Aggregated data will be shared