Clinical trial NCT04427280: Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)
Official title: Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Disease
Cancer
Coronavirus Infection
Keywords: COVID-19
SARS-CoV-2
Cancer
Coronavirus infection
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: St George's, University of London
name: Mologic Ltd
name: The Royal Marsden Cancer Charity
name: National Institute for Health Research Biomedical Research Centre
First posted: 2020-06-11
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (greater than or equal to 18 years of age) presenting with suspected COVID-19 infection.

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.

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.

Primary outcomes:
measure: Proportion of patients, at each sample timepoint, with a positive detection of IgM and IgG specific antibodies to SARS-CoV-2.
timeFrame: 56 days
Secondary outcomes:
measure: Clinical course of SARS-CoV-2 infection in cancer patients.
timeFrame: 56 days
measure: Clinical course of SARS-CoV-2 infection in cancer patients.
timeFrame: 56 days
measure: Clinical course of SARS-CoV-2 infection in cancer patients.
timeFrame: 56 days
measure: Proportion of patients, at each sample timepoint, with SARS-CoV-2 viral clearance by throat/nose swab by RT-PCR.
timeFrame: 56 days
measure: Time from start of symptoms to Day 0 testing in the study.
timeFrame: 56 days
measure: Feasibility of SARS-CoV-2 testing with a lateral flow assay.
timeFrame: 56 days
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Sheela Rao, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lau DK, Aresu M, Planche T, Tran A, Lazaro-Alcausi R, Duncan J, Kidd S, Cromarty S, Begum R, Rana I, Li S, Suwaidan AA, Monahan I, Clark DJ, Eckersley N, Staines HM, Groppelli E, Krishna S, Mayora-Neto M, Temperton N, Fribbens C, Watkins D, Starling N, Chau I, Cunningham D, Rao S. SARS-CoV-2 Vaccine Immunogenicity in Patients with Gastrointestinal Cancer Receiving Systemic Anti-Cancer Therapy. Oncologist. 2023 Jan 18;28(1):e1-e8. doi: 10.1093/oncolo/oyac230.