Correlative Study on Cancer Patients and Healthcare Professionals Exposed to Infection by Severe Acute Respiratory Syndrome-Corona Virus-2 (SARS-Cov-2), COVID-19 Causative Agent.

Study Overview
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Brief Summary
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Translational, prospective / retrospective, non-profit, non-pharmacological study, with cohort characteristics. The study consists of two parts: the first to study epidemiological aspects of the spread of the disease and the second one to identify infection-related genetic factors.

Detailed Description
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The outbreak of COVID-19 infections is spreading in Italy with unprecedented severity characteristics. In this context, it is essential to collect data relating to the epidemiology of the disease, to outline further useful tools for diagnosis and to define the correct use of rapid molecular and / or serological tests in the surveillance of high-risk subjects (cancer patients and healthcare operators), in order to identify any new disease control strategies, crucial to reduce the transmission and to outline specific guidelines for cancer patients healthcare management. It is also necessary to identify the factors that determine the evolution of the viral genome over time in the various geographical areas and also the potential susceptibility markers in the different types of affected subjects (symptomatic, mildly symptomatic and asymptomatic).

Official Title
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Correlative Study on Cancer Patients and Healthcare Professionals Exposed to SARS-CoV-2 Infection

Conditions
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COVID-19, SARS-CoV-2

Intervention / Treatment
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* Other: serological test
* Other: Rapid molecular test
* Genetic: Next generation Sequencing (NGS) analysis
* Other: serum chemistry analysis


Participation Criteria
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Eligibility Criteria
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For epidemiologic analysis: Inclusion Criteria: Age > 18 years asymptomatic One of the following three conditions: • Healthy subjects who have had contact with COVID-19 positive patients • Healthcare workers • oncological patients candidates for cytotoxic chemotherapy at myeloablative doses (such as transplants) or treated with immune-check point inhibitors. informed consent to the study and processing of data Exclusion Criteria: presence of symptoms for COronaVIrus Disease 19 (COVID-19) (fever > 37.5 °, cough, shortness of breath) For analysis of viral/host genetic factors involved in susceptibility/resistance to infection, samples from patients with confirmed diagnosis of COVID-19, residual from diagnostic procedures will be analyzed. All samples for genetic analysis will be anonymized.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| asymptomatic population at high risk of infection<br>healthy individuals at high risk of infection, including individuals who have had contact with a patient tested positive for COVID-19, voluntary health workers and oncological patients candidate to immunosuppressive therapy | Other: serological test<br>* serological test assessing IgM and IgG directed against SARS-CoV-2<br>Other: Rapid molecular test<br>* Molecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab<br>Other: serum chemistry analysis<br>* Analysis of serum chemistry factors and coagulation panel in blood samples<br>|
| COVID-19 patients<br>patients with confirmed diagnosis of COVID-19 | Genetic: Next generation Sequencing (NGS) analysis<br>* analysis of genetic variability of virus and host<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epidemiology | Investigate the epidemiology of the infection in an asymptomatic population including both healthy individuals at high risk of infection and oncological patients by assessing the seroprevalence of IgG and IgM antibodies against the SARS-CoV-2 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation | IgG and IgM antibodies evaluation over time | 12 months | 
| methods comparison | Make a comparison between different serological investigation methods and rapid molecular methods becoming available | 24 months | 
| correlation between biochemical and coagulative factors with SARS-CoV-2 positivity. | To evaluate correlation between biochemical and coagulative factors with SARS-CoV-2 positivity | 24 months | 
| phylogenetic map | Building a phylogenetic map of an epidemic Italian macro-region | 24 months | 
| interactions between the virus and host cells | Evaluate the spectrum of possible interactions between the virus and host cells, considering their genetic variability / instability in patients diagnosed with COVID-19 | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19, cancer, IgM-IgG, seroprevalence