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

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.

Completed
Infectious Disease
Cancer
Coronavirus 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.

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United Kingdom
Locations

The Royal Marden NHS Foundation Trust
Sutton, Surrey, United Kingdom

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

Royal Marsden NHS Foundation Trust
NCT Number
Keywords
Covid-19
SARS-CoV-2
cancer
Coronavirus infection
MeSH Terms
Infections
COVID-19
Coronavirus Infections
Communicable Diseases