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.

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS500 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

COVID-19 SARS-CoV-2

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation

IgG and IgM antibodies evaluation over time

Time frame: 12 months

methods comparison

Make a comparison between different serological investigation methods and rapid molecular methods becoming available

Time frame: 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

Time frame: 24 months

phylogenetic map

Building a phylogenetic map of an epidemic Italian macro-region

Time frame: 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

Time frame: 24 months

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.

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts