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

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

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).

Recruiting
COVID-19
SARS-CoV-2

Other: serological test
serological test assessing IgM and IgG directed against SARS-CoV-2
asymptomatic population at high risk of infection

Other: Rapid molecular test
Molecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab
asymptomatic population at high risk of infection

Genetic: Next generation Sequencing (NGS) analysis
analysis of genetic variability of virus and host
COVID-19 patients

Other: serum chemistry analysis
Analysis of serum chemistry factors and coagulation panel in blood samples
asymptomatic population at high risk of infection

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Italy
Contacts

Giovanni Martinelli, Prof
+39 0543 739100
giovanni.martinelli@irst.emr.it

Oriana Nanni, Dr
+39 0543 739100
oriana.nanni@irst.emr.it

Giovanni Martinelli, Prof.
Principal Investigator
IRST IRCCS

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
AUSL Romagna
NCT Number
Keywords
SARS-CoV-2
Covid-19
cancer
IgM-IgG
seroprevalence
MeSH Terms
Infection