Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)
NCT ID: NCT04427280
Last Updated: 2025-09-04
Study Results
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View full resultsBasic Information
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COMPLETED
153 participants
OBSERVATIONAL
2020-05-26
2021-06-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Arm A
Suspected acute COVID-19 infection
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.
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.
Blood collection
Approximately 30mL of blood will be taken at each study visit.
Arm B
Asymptomatic patients with no clinical suspicion of COVID-19
Blood collection
Approximately 30mL of blood will be taken at each study visit.
Interventions
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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.
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.
Blood collection
Approximately 30mL of blood will be taken at each study visit.
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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St George's, University of London
OTHER
Mologic Ltd
INDUSTRY
The Royal Marsden Cancer Charity
UNKNOWN
National Institute for Health Research Biomedical Research Centre
UNKNOWN
Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Sheela Rao, MD FRCP
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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The Royal Marden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form: Arm A
Document Type: Informed Consent Form: Arm B
Other Identifiers
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20/NE/0139
Identifier Type: OTHER
Identifier Source: secondary_id
CCR 5287
Identifier Type: -
Identifier Source: org_study_id
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