Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19) (CARDS)
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|ClinicalTrials.gov Identifier: NCT04427280|
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
|Condition or disease|
|Infectious Disease Cancer Coronavirus Infection|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)|
|Actual Study Start Date :||May 26, 2020|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||April 2021|
- Proportion of patients, at each sample timepoint, with a positive detection of IgM and IgG specific antibodies to SARS-CoV-2. [ Time Frame: 56 days ]
- Clinical course of SARS-CoV-2 infection in cancer patients. [ Time Frame: 56 days ]Duration of clinical symptoms
- Clinical course of SARS-CoV-2 infection in cancer patients. [ Time Frame: 56 days ]Severity of clinical symptoms
- Clinical course of SARS-CoV-2 infection in cancer patients. [ Time Frame: 56 days ]Number of patients whose cancer treatment has been impacted by SARS-CoV-2
- Proportion of patients, at each sample timepoint, with SARS-CoV-2 viral clearance by throat/nose swab by RT-PCR. [ Time Frame: 56 days ]
- Time from start of symptoms to Day 0 testing in the study. [ Time Frame: 56 days ]
- Feasibility of SARS-CoV-2 testing with a lateral flow assay. [ Time Frame: 56 days ]
- Proportion of samples successfully processed and result obtained, with 95% confidence interval
- Proportion of samples processed with a positive result by lateral flow, by the gold standard (throat/nose RT-PCR)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427280
|Contact: Sue Cromarty||+44 (0) 208 661 3807||Sue.Cromarty@rmh.nhs.uk|
|Contact: Shannon Kidd||+44 (0) 208 661 3807||Shannon.Kidd@rmh.nhs.uk|
|The Royal Marden NHS Foundation Trust||Recruiting|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Contact: Sue Cromarty +44 (0) 208 661 3807 Sue.Cromarty@rmh.nhs.uk|
|Contact: Shannon Kidd +44 (0) 208 661 3807 Shannon.Kidd@rmh.nhs.uk|
|Principal Investigator: Sheela Rao, MD FRCP|
|Sub-Investigator: David Lau, MBBS FRACP|
|Principal Investigator:||Sheela Rao, MD FRCP||Royal Marsden NHS Foundation Trust|