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

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

Recruiting
18 years and older
All
Phase N/A

Overview

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.

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.

Eligibility

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 details
    Coronavirus Infection
    Cancer
    Infection

NCT04427280

Royal Marsden NHS Foundation Trust

16 February 2024

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