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

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Royal Marsden NHS Foundation Trust
Updated on 19 February 2024
cancer
lymphoma
covid-19
SARS
acute respiratory syndrome (sars)

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.

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.

Details
Condition Coronavirus Infection, Cancer, Infection
Age 18-100 years
Clinical Study IdentifierNCT04427280
SponsorRoyal Marsden NHS Foundation Trust
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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