<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/NCT04427280</url>
  </required_header>
  <id_info>
    <org_study_id>CCR 5287</org_study_id>
    <secondary_id>20/NE/0139</secondary_id>
    <nct_id>NCT04427280</nct_id>
  </id_info>
  <brief_title>Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)</brief_title>
  <acronym>CARDS</acronym>
  <official_title>Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Marsden NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St George's, University of London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mologic Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Royal Marsden Cancer Charity</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Health Research Biomedical Research Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Marsden NHS Foundation Trust</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>
      People with cancer may be at higher risk of poor outcomes with COVID-19 infection. This&#xD;
      observational study aims to describe the clinical course of COVID-19 infection in people with&#xD;
      cancer and evaluate the utility of antibody and antigen tests for COVID-19. The results of&#xD;
      this study will inform clinical practice in the management of cancer patients with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with cancer are thought to have a weakened immune system and small observational&#xD;
      case series have suggested patients with cancer are at a higher risk of poor outcome from&#xD;
      COVID-19. However, the clinical course of COVID-19 infection amongst cancer patients is not&#xD;
      known. In addition, it is unclear when it is appropriate for cancer patients who have&#xD;
      recovered from COVID-19 infection to resume anti-cancer therapy.&#xD;
&#xD;
      There is unmet need for diagnostic assays for COVID-19 including tests which can rapidly&#xD;
      determine whether the virus has been cleared of the COVID-19. Lateral flow assays&#xD;
      investigated in this study are rapid and simple diagnostic tools which can assist in timely&#xD;
      diagnostics to inform clinical decision making.&#xD;
&#xD;
      This observational study aims to describe the immunological dynamics and clinical course of&#xD;
      COVID-19 in cancer patients and evaluate COVID-19 antibody and antigen lateral flow assays.&#xD;
&#xD;
      The information from our study will add significantly to the understanding of COVID-19&#xD;
      diagnostics and will improve the evidence-base for the management of cancer patients.&#xD;
      Furthermore, data from this study could inform the timing and treatment for cancer patients&#xD;
      who have recovered from COVID-19 infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Actual">June 29, 2021</completion_date>
  <primary_completion_date type="Actual">June 29, 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>Proportion of patients, at each sample timepoint, with a positive detection of IgM and IgG specific antibodies to SARS-CoV-2.</measure>
    <time_frame>56 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical course of SARS-CoV-2 infection in cancer patients.</measure>
    <time_frame>56 days</time_frame>
    <description>Duration of clinical symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical course of SARS-CoV-2 infection in cancer patients.</measure>
    <time_frame>56 days</time_frame>
    <description>Severity of clinical symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical course of SARS-CoV-2 infection in cancer patients.</measure>
    <time_frame>56 days</time_frame>
    <description>Number of patients whose cancer treatment has been impacted by SARS-CoV-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients, at each sample timepoint, with SARS-CoV-2 viral clearance by throat/nose swab by RT-PCR.</measure>
    <time_frame>56 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from start of symptoms to Day 0 testing in the study.</measure>
    <time_frame>56 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of SARS-CoV-2 testing with a lateral flow assay.</measure>
    <time_frame>56 days</time_frame>
    <description>Proportion of samples successfully processed and result obtained, with 95% confidence interval&#xD;
Proportion of samples processed with a positive result by lateral flow, by the gold standard (throat/nose RT-PCR)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">153</enrollment>
  <condition>Infectious Disease</condition>
  <condition>Cancer</condition>
  <condition>Coronavirus Infection</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <description>Suspected acute COVID-19 infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <description>Asymptomatic patients with no clinical suspicion of COVID-19</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Throat/nose swabs</intervention_name>
    <description>Throat/nose swabs will initially be collected at baseline (D0) as part of the diagnostic workup for SARS-CoV-2 infection. Subsequent throat/nose swabs will be taken at D7 (if an inpatient), D14, D28, D42 and D56. Two samples will be taken, one for standard of care testing and one for lateral flow assay and storage for further analysis later such as quantitative PCR.</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Saliva collection</intervention_name>
    <description>Saliva will be collected at each study visit, by asking the participant to provide a small amount of saliva (approximately 0.5mL) will be collected. Saliva will be tested by the lateral flow assay when available and excess material stored.</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood collection</intervention_name>
    <description>Approximately 30mL of blood will be taken at each study visit.</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients (greater than or equal to 18 years of age) presenting with suspected&#xD;
        COVID-19 infection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected COVID-19 infection undergoing diagnostic testing by SARS-CoV-2 RT-PCR&#xD;
&#xD;
          -  Metastatic or advanced solid organ malignancy, including lymphoma OR Early stage solid&#xD;
             organ malignancy having received therapy (radiotherapy, chemotherapy or targeted&#xD;
             agents)&#xD;
&#xD;
          -  Patient is ≥ 18 years of age.&#xD;
&#xD;
          -  Patient can understand the patient information sheet and is able to provide written&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no exclusion criteria for this study.&#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>Sheela Rao, MD FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Marsden NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Royal Marden NHS Foundation Trust</name>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>November 15, 2021</last_update_submitted>
  <last_update_submitted_qc>November 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Cancer</keyword>
  <keyword>Coronavirus infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>December 1, 2022</submitted>
  </pending_results>
  <!-- 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/NCT04427280
org study id: CCR 5287
secondary id: 20/NE/0139
nct id: NCT04427280
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
People with cancer may be at higher risk of poor outcomes with COVID-19 infection. This
      observational study aims to describe the clinical course of COVID-19 infection in people with
      cancer and evaluate the utility of antibody and antigen tests for COVID-19. The results of
      this study will inform clinical practice in the management of cancer patients with COVID-19.
Patients with cancer are thought to have a weakened immune system and small observational
      case series have suggested patients with cancer are at a higher risk of poor outcome from
      COVID-19. However, the clinical course of COVID-19 infection amongst cancer patients is not
      known. In addition, it is unclear when it is appropriate for cancer patients who have
      recovered from COVID-19 infection to resume anti-cancer therapy.

      There is unmet need for diagnostic assays for COVID-19 including tests which can rapidly
      determine whether the virus has been cleared of the COVID-19. Lateral flow assays
      investigated in this study are rapid and simple diagnostic tools which can assist in timely
      diagnostics to inform clinical decision making.

      This observational study aims to describe the immunological dynamics and clinical course of
      COVID-19 in cancer patients and evaluate COVID-19 antibody and antigen lateral flow assays.

      The information from our study will add significantly to the understanding of COVID-19
      diagnostics and will improve the evidence-base for the management of cancer patients.
      Furthermore, data from this study could inform the timing and treatment for cancer patients
      who have recovered from COVID-19 infection.
observational model: Cohort
time perspective: Prospective
measure: Proportion of patients, at each sample timepoint, with a positive detection of IgM and IgG specific antibodies to SARS-CoV-2.
time frame: 56 days
measure: Clinical course of SARS-CoV-2 infection in cancer patients.
time frame: 56 days
description: Duration of clinical symptoms
measure: Clinical course of SARS-CoV-2 infection in cancer patients.
time frame: 56 days
description: Severity of clinical symptoms
measure: Clinical course of SARS-CoV-2 infection in cancer patients.
time frame: 56 days
description: Number of patients whose cancer treatment has been impacted by SARS-CoV-2
measure: Proportion of patients, at each sample timepoint, with SARS-CoV-2 viral clearance by throat/nose swab by RT-PCR.
time frame: 56 days
measure: Time from start of symptoms to Day 0 testing in the study.
time frame: 56 days
measure: Feasibility of SARS-CoV-2 testing with a lateral flow assay.
time frame: 56 days
description: Proportion of samples successfully processed and result obtained, with 95% confidence interval
Proportion of samples processed with a positive result by lateral flow, by the gold standard (throat/nose RT-PCR)
arm group label: Arm A
description: Suspected acute COVID-19 infection
arm group label: Arm B
description: Asymptomatic patients with no clinical suspicion of COVID-19
intervention type: Diagnostic Test
intervention name: Throat/nose swabs
description: Throat/nose swabs will initially be collected at baseline (D0) as part of the diagnostic workup for SARS-CoV-2 infection. Subsequent throat/nose swabs will be taken at D7 (if an inpatient), D14, D28, D42 and D56. Two samples will be taken, one for standard of care testing and one for lateral flow assay and storage for further analysis later such as quantitative PCR.
arm group label: Arm A
intervention type: Diagnostic Test
intervention name: Saliva collection
description: Saliva will be collected at each study visit, by asking the participant to provide a small amount of saliva (approximately 0.5mL) will be collected. Saliva will be tested by the lateral flow assay when available and excess material stored.
arm group label: Arm A
intervention type: Diagnostic Test
intervention name: Blood collection
description: Approximately 30mL of blood will be taken at each study visit.
arm group label: Arm A
arm group label: Arm B
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sheela Rao, MD FRCP
role: Principal Investigator
affiliation: Royal Marsden NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Infections
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Communicable Diseases
submitted: December 1, 2022