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

November 15, 2021 updated by: Royal Marsden NHS Foundation Trust
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (greater than or equal to 18 years of age) presenting with suspected COVID-19 infection.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm A
Suspected acute COVID-19 infection
Diagnostic test: Throat/nose swabs
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.
Diagnostic test: Saliva collection
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.
Diagnostic test: Blood collection
Approximately 30mL of blood will be taken at each study visit.
Arm B
Asymptomatic patients with no clinical suspicion of COVID-19
Diagnostic test: Blood collection
Approximately 30mL of blood will be taken at each study visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
56 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical course of SARS-CoV-2 infection in cancer patients.
Time Frame: 56 days
Duration of clinical symptoms
56 days
Clinical course of SARS-CoV-2 infection in cancer patients.
Time Frame: 56 days
Severity of clinical symptoms
56 days
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
56 days
Proportion of patients, at each sample timepoint, with SARS-CoV-2 viral clearance by throat/nose swab by RT-PCR.
Time Frame: 56 days
56 days
Time from start of symptoms to Day 0 testing in the study.
Time Frame: 56 days
56 days
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)
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

St George's, University of London
Mologic Ltd
The Royal Marsden Cancer Charity
National Institute for Health Research Biomedical Research Centre

Investigators

  • Principal Investigator: Sheela Rao, MD FRCP, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2020

Primary Completion (Actual)

June 29, 2021

Study Completion (Actual)

June 29, 2021

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR 5287
  • 20/NE/0139 (Other Identifier: Research Ethics Committee)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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