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.
- Conditions
- SARS-CoV-2COVID-19
- Interventions
- Genetic: Next generation Sequencing (NGS) analysisOther: serological testOther: Rapid molecular testOther: serum chemistry analysis
- Registration Number
- NCT04345315
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description asymptomatic population at high risk of infection serum chemistry analysis 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 COVID-19 patients Next generation Sequencing (NGS) analysis patients with confirmed diagnosis of COVID-19 asymptomatic population at high risk of infection serological test 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 asymptomatic population at high risk of infection Rapid molecular test 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
- Primary Outcome Measures
Name Time Method epidemiology 12 months 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
- Secondary Outcome Measures
Name Time Method methods comparison 24 months Make a comparison between different serological investigation methods and rapid molecular methods becoming available
Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation 12 months IgG and IgM antibodies evaluation over time
phylogenetic map 24 months Building a phylogenetic map of an epidemic Italian macro-region
correlation between biochemical and coagulative factors with SARS-CoV-2 positivity. 24 months To evaluate correlation between biochemical and coagulative factors with SARS-CoV-2 positivity
interactions between the virus and host cells 24 months Evaluate the spectrum of possible interactions between the virus and host cells, considering their genetic variability / instability in patients diagnosed with COVID-19
Trial Locations
- Locations (2)
Irst Irccs
🇮🇹Meldola, FC, Italy
UO Microbiologia,Centro Servizi Pievesestina, AUSL Romagna
🇮🇹Cesena, FC, Italy