Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infectious Disease
- Sponsor
- Royal Marsden NHS Foundation Trust
- Enrollment
- 153
- Locations
- 1
- Primary Endpoint
- Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein).
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Percentage of Patients at Each Sample Timepoint With a Positive Detection of Immunoglobulin G (IgG) Specific Antibodies to SARS-CoV-2 (Spike-protein).
Time Frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
Percentage of patients at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of IgG specific antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) (spike-protein). Serum SARS-CoV-2 S1 RBD Spike antibodies (anti-S) were measured using the COV2T assay on an Atellica analyser (Siemens). Index values ≥ 1.0 were considered positive as per the manufacturer's protocol.
Percentage of Patients at Each Sample Timepoint With a Positive Detection of IgG Specific Antibodies to SARS-CoV-2 (Nucleocapsid).
Time Frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
Percentage of patients at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of IgG specific antibodies to SARS-CoV-2 (nucleocapsid). Nucleocapsid (anti-N) antibodies were analysed with the Elecsys SARS-CoV-2 assay on a Cobas analyser (Roche). As specified by the manufacturer, values above a cut-off index (COI) ≥ 1.0 were reported as positive.
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)
Time Frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
Percentage of patients at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of IgG specific antibodies to SARS-CoV-2 (spike-protein). Serum SARS-CoV-2 S1 RBD Spike antibodies (anti-S) were measured using the COV2T assay on an Atellica analyser (Siemens). Index values ≥ 1.0 were considered positive as per the manufacturer's protocol.
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)
Time Frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84
Percentage of patients at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of IgG specific antibodies to SARS-CoV-2 (nucleocapsid). Nucleocapsid (anti-N) antibodies were analysed with the Elecsys SARS-CoV-2 assay on a Cobas analyser (Roche). As specified by the manufacturer, values above a cut-off index (COI) ≥ 1.0 were reported as positive.
Secondary Outcomes
- 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(Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84)
- 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(Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84)
- 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.(Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84)
- 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.(Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84)
- 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(0-19 days, 20-39 days, 40-59 days, 60-79 days, 80-99 days from the date of the patient's 1st SARS-CoV-2 vaccine dose (relative to each patient))
- Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose(0-19 days, 20-39 days, 40-59 days, 60-79 days, 80-99 days from the date of the patient's 1st SARS-CoV-2 vaccine dose (relative to each patient))
- Sensitivity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.(Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84)
- Specificity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.(Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84)