NCT04345315

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.

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
OTHER	serological test	serological test assessing IgM and IgG directed against SARS-CoV-2
OTHER	Rapid molecular test	Molecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab
GENETIC	Next generation Sequencing (NGS) analysis	analysis of genetic variability of virus and host
OTHER	serum chemistry analysis	Analysis of serum chemistry factors and coagulation panel in blood samples

Timeline

• Start date: 2020-03-27
• Primary completion: 2021-03-01
• Completion: 2022-03-01
• First posted: 2020-04-14
• Last updated: 2020-04-15

Locations

2 sites across 1 country: Italy