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

NCT04427280 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 153

Last updated 2025-09-04

Study results available
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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.

Conditions

Interventions

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 0.5 millilitres (mL)) 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.

Sponsors & Collaborators

  • St George's, University of London

    collaborator OTHER
  • Mologic Ltd

    collaborator INDUSTRY
  • The Royal Marsden Cancer Charity

    collaborator UNKNOWN
  • National Institute for Health Research Biomedical Research Centre

    collaborator UNKNOWN
  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Sheela Rao, MD FRCP · Royal Marsden NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-26
Primary Completion
2021-06-29
Completion
2021-06-29

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04427280 on ClinicalTrials.gov