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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infectious Disease, Cancer, Coronavirus Infection

Intervention / Treatment
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* Diagnostic Test: Throat/nose swabs
* Diagnostic Test: Saliva collection
* Diagnostic Test: Blood collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: There are no exclusion criteria for this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A<br>Suspected acute COVID-19 infection | Diagnostic Test: Throat/nose swabs<br>* 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.<br>Diagnostic Test: Saliva collection<br>* Saliva will be collected at each study visit, by asking the participant to provide a small amount of saliva (approximately 0.5mL) will be collected. Saliva will be tested by the lateral flow assay when available and excess material stored.<br>Diagnostic Test: Blood collection<br>* Approximately 30mL of blood will be taken at each study visit.<br>|
| Arm B<br>Asymptomatic patients with no clinical suspicion of COVID-19 | Diagnostic Test: Blood collection<br>* Approximately 30mL of blood will be taken at each study visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical course of SARS-CoV-2 infection in cancer patients. | Duration of clinical symptoms | 56 days | 
| Clinical course of SARS-CoV-2 infection in cancer patients. | Severity of clinical symptoms | 56 days | 
| Clinical course of SARS-CoV-2 infection in cancer patients. | Number of patients whose cancer treatment has been impacted by SARS-CoV-2 | 56 days | 
| Proportion of patients, at each sample timepoint, with SARS-CoV-2 viral clearance by throat/nose swab by RT-PCR. |  | 56 days | 
| Time from start of symptoms to Day 0 testing in the study. |  | 56 days | 
| Feasibility of SARS-CoV-2 testing with a lateral flow assay. | 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) | 56 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, COVID-19, SARS-CoV-2, Coronavirus infection