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. (CORSA)

April 14, 2020 updated by: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • FC
      • Cesena, FC, Italy, 47522
        • Active, not recruiting
        • UO Microbiologia,Centro Servizi Pievesestina, AUSL Romagna
      • Meldola, FC, Italy, 47014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

For epidemiologic analysis, asymptomatic population 350 health workers / healthy subjects at risk of infection and 50 cancer patients candidates for immunosuppressive therapies will be enrolled.

For analysis of genetic variability of virus and host factors impacting on susceptibility to infection: samples from about 100 SARS-CoV-2 positive patients (sintomatic, paucisintomatic or asymptomatic), retained at Pievesestina Laboratory after diagnostic procedure, will be analyzed. All samples for genetic analysis will be anonymized.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
asymptomatic population at high risk of infection
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
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
Other: serum chemistry analysis
Analysis of serum chemistry factors and coagulation panel in blood samples
COVID-19 patients
patients with confirmed diagnosis of COVID-19
Genetic: Next generation Sequencing (NGS) analysis
analysis of genetic variability of virus and host

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
epidemiology
Time Frame: 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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation
Time Frame: 12 months
IgG and IgM antibodies evaluation over time
12 months
methods comparison
Time Frame: 24 months
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.
Time Frame: 24 months
To evaluate correlation between biochemical and coagulative factors with SARS-CoV-2 positivity
24 months
phylogenetic map
Time Frame: 24 months
Building a phylogenetic map of an epidemic Italian macro-region
24 months
interactions between the virus and host cells
Time Frame: 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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Collaborators

AUSL ROMAGNA

Investigators

  • Principal Investigator: Giovanni Martinelli, Prof., Irst Irccs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRSTB113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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