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Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19) (CARDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04427280
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
St George's, University of London
Mologic Ltd
The Royal Marsden Cancer Charity
National Institute for Health Research Biomedical Research Centre
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:
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.

Condition or disease
Infectious Disease Cancer Coronavirus Infection

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)
Actual Study Start Date : May 26, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Clinical course of SARS-CoV-2 infection in cancer patients. [ Time Frame: 56 days ]
    Duration of clinical symptoms

  2. Clinical course of SARS-CoV-2 infection in cancer patients. [ Time Frame: 56 days ]
    Severity of clinical symptoms

  3. Clinical course of SARS-CoV-2 infection in cancer patients. [ Time Frame: 56 days ]
    Number of patients whose cancer treatment has been impacted by SARS-CoV-2

  4. Proportion of patients, at each sample timepoint, with SARS-CoV-2 viral clearance by throat/nose swab by RT-PCR. [ Time Frame: 56 days ]
  5. Time from start of symptoms to Day 0 testing in the study. [ Time Frame: 56 days ]
  6. Feasibility of SARS-CoV-2 testing with a lateral flow assay. [ Time Frame: 56 days ]
    1. Proportion of samples successfully processed and result obtained, with 95% confidence interval
    2. Proportion of samples processed with a positive result by lateral flow, by the gold standard (throat/nose RT-PCR)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (greater than or equal to 18 years of age) presenting with suspected COVID-19 infection.
Criteria

Inclusion Criteria:

  • Suspected COVID-19 infection undergoing diagnostic testing by SARS-CoV-2 RT-PCR
  • Metastatic or advanced solid organ malignancy, including lymphoma OR Early stage solid organ malignancy having received therapy (radiotherapy, chemotherapy or targeted agents)
  • Patient is ≥ 18 years of age.
  • Patient can understand the patient information sheet and is able to provide written informed consent.

Exclusion Criteria:

  • There are no exclusion criteria for this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427280


Contacts
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Contact: Sue Cromarty +44 (0) 208 661 3807 Sue.Cromarty@rmh.nhs.uk
Contact: Shannon Kidd +44 (0) 208 661 3807 Shannon.Kidd@rmh.nhs.uk

Locations
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United Kingdom
The Royal Marden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Sue Cromarty    +44 (0) 208 661 3807    Sue.Cromarty@rmh.nhs.uk   
Contact: Shannon Kidd    +44 (0) 208 661 3807    Shannon.Kidd@rmh.nhs.uk   
Principal Investigator: Sheela Rao, MD FRCP         
Sub-Investigator: David Lau, MBBS FRACP         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
St George's, University of London
Mologic Ltd
The Royal Marsden Cancer Charity
National Institute for Health Research Biomedical Research Centre
Investigators
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Principal Investigator: Sheela Rao, MD FRCP Royal Marsden NHS Foundation Trust
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04427280    
Other Study ID Numbers: CCR 5287
20/NE/0139 ( Other Identifier: Research Ethics Committee )
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal Marsden NHS Foundation Trust:
COVID-19
SARS-CoV-2
Cancer
Coronavirus infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases