N/A
N=153
Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)
Infectious Disease · Cancer · Coronavirus Infection
Bottom Line
View on ClinicalTrials.gov: NCT04427280 ↗Enrolled (actual)
153
Serious AEs
—
Results posted
Sep 2025
Primary outcome: Primary: Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein). — 34.9; 38.3; 52.7; 61.9 Percentage of patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Throat/nose swabs (Diagnostic_test); Saliva collection (Diagnostic_test); Blood collection (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Royal Marsden NHS Foundation Trust
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein). |
34.9; 38.3; 52.7; 61.9 | — |
| PRIMARY Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid). |
14.7; 14.0; 16.1; 14.3 | — |
| PRIMARY Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), Across Patients Who Had Blood Test Results Available at All Blood Sample Timepoints (Day 0, Day 28, Day 56, Day 84) |
34.6; 41; 50; 60.3 | — |
| PRIMARY Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid), Across Patients Who Had Blood Test Results Available at All Blood Sample Timepoints (Day 0, Day 28, Day 56, Day 84) |
12.5; 12.5; 12.5; 12.5 | — |
| SECONDARY Percentage of Participants at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), in Patients Who Received at Least One SARS-CoV-2 Vaccine Dose Prior to Day 0 |
61.9; 71.7; 81.3; 91.5 | — |
| SECONDARY Percentage of Participants at Each Sample Timepoint With a Positive Detection of Pseudovirus Neutralisation (1/40 Titre), in Patients Who Received at Least One SARS-CoV-2 Vaccine Dose Prior to Day 0 |
59.4; 67.9; 60; 83 | — |
| SECONDARY Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), in Patients Who Did Not Receive a SARS-CoV-2 Vaccine Dose During the Study. |
8.2; 7; 14.7; 3.7 | — |
| SECONDARY Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid), in Patients Who Did Not Receive a SARS-CoV-2 Vaccine Dose During the Study. |
7.8; 6.8; 11.8; 3.7 | — |
| SECONDARY Percentage of Participants With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Spike-protein), at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose |
30; 70.2; 64.4; 79.5; 86.1 | — |
| SECONDARY Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose |
40.4; 71.9; 57.8; 65; 68.2 | — |
| SECONDARY Sensitivity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold. |
88.5; 80.8; 89.8; 96.7 | — |
| SECONDARY Specificity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold. |
94.7; 90.8; 76.2; 86.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Suspected COVID-19 infection undergoing diagnostic testing by SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (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.
Data sourced from ClinicalTrials.gov (NCT04427280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.