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NCT Number: NCT04427280

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

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.

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Key information

Conditions

Infectious Disease COVID-19 Cancer Communicable Diseases Coronaviridae Infections Coronavirus Infection Coronavirus Infections Disease Attributes Infections Lung Diseases Neoplasms Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Throat/nose swabs

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

Approximately 30mL of blood will be taken at each study visit.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. 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

    Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84

    Percentage of participants 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), in patients who received at least one SARS-CoV-2 vaccine prior to Day 0. 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.

  2. 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

    Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84

    Percentage of participants at each sample timepoint (Day 0 (baseline blood collection), Day 28, Day 56, Day 84) with a positive detection of pseudovirus neutralisation (1/40 titre), in patients who received at least one SARS-CoV-2 vaccine prior to Day 0. A pseudovirus assay was used to assess the prevalence of positive neutralising antibodies (achieving pVNT50 at 1/40 serum dilution).

  3. 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.

    Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84

    Percentage of patients at each sample timepoint (Day 0 (baseline), Day 28, Day 56, Day 84) 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 during the study. 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.

  4. 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.

    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), in patients who did not receive a COVID-19 vaccine during the study. 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.

  5. 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

    Time frame: 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 IgG specific antibodies to SARS-CoV-2 (spike-protein), at time periods relative to the date of 1st SARS-CoV-2 vaccine dose. 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.

  6. Percentage of Participants With a Positive Detection of Pseudovirus Neutralisation, at Time Periods Relative to the Date of 1st SARS-CoV-2 Vaccine Dose

    Time frame: 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 (1/40 titre), at time periods relative to the date of 1st SARS-CoV-2 vaccine dose. A pseudovirus assay was used to assess the prevalence of positive neutralising antibodies (achieving pVNT50 at 1/40 serum dilution)

  7. Sensitivity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.

    Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84

    Sensitivity: the percentage of participants with a positive detection of IgG specific antibodies to SARS-CoV-2 (spike protein) out of those who had a positive neutralisation detection at the PV50 threshold from the pseudovirus assay, at each sample timepoint. 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. A pseudovirus assay was used to assess the prevalence of positive neutralising antibodies (achieving pVNT50 at 1/40 serum dilution).

  8. Specificity of the Siemens Test (Spike-protein) at Each Sample Timepoint (D0, D28, D56, D84), Against Pseudovirus Neutralisation Results at the PV50 Threshold.

    Time frame: Blood collection timepoints: Day 0 (baseline), Day 28, Day 56, Day 84

    Specificity: the percentage of participants with a negative detection of IgG specific antibodies to SARS-CoV-2 (spike protein) out of those who had a negative neutralisation detection at the PV50 threshold from the pseudovirus assay, at each sample timepoint. 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. A pseudovirus assay was used to assess the prevalence of positive neutralising antibodies (achieving pVNT50 at 1/40 serum dilution)

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Collaborators

  • Mologic Ltd
  • National Institute for Health Research Biomedical Research Centre
  • St George's, University of London
  • The Royal Marsden Cancer Charity

Registry information

Acronym: CARDS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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