Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)
- Conditions
- CancerInfectious DiseaseCoronavirus Infection
- Interventions
- Diagnostic Test: Throat/nose swabsDiagnostic Test: Saliva collectionDiagnostic Test: Blood collection
- Registration Number
- NCT04427280
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- Suspected COVID-19 infection undergoing diagnostic testing by SARS-CoV-2 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.
- There are no exclusion criteria for this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm A Throat/nose swabs Suspected acute COVID-19 infection Arm A Saliva collection Suspected acute COVID-19 infection Arm A Blood collection Suspected acute COVID-19 infection Arm B Blood collection Asymptomatic patients with no clinical suspicion of COVID-19
- Primary Outcome Measures
Name Time Method Proportion of patients, at each sample timepoint, with a positive detection of IgM and IgG specific antibodies to SARS-CoV-2. 56 days
- Secondary Outcome Measures
Name Time Method Clinical course of SARS-CoV-2 infection in cancer patients. 56 days Number of patients whose cancer treatment has been impacted by SARS-CoV-2
Time from start of symptoms to Day 0 testing in the study. 56 days Proportion of patients, at each sample timepoint, with SARS-CoV-2 viral clearance by throat/nose swab by RT-PCR. 56 days Feasibility of SARS-CoV-2 testing with a lateral flow assay. 56 days 1. Proportion of samples successfully processed and result obtained, with 95% confidence interval
2. Proportion of samples processed with a positive result by lateral flow, by the gold standard (throat/nose RT-PCR)
Trial Locations
- Locations (1)
The Royal Marden NHS Foundation Trust
🇬🇧Sutton, Surrey, United Kingdom