- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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. (CORSA)
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
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Giovanni Martinelli, Prof
- Phone Number: +39 0543 739100
- Email: giovanni.martinelli@irst.emr.it
Study Contact Backup
- Name: Oriana Nanni, Dr
- Phone Number: +39 0543 739100
- Email: oriana.nanni@irst.emr.it
Study Locations
-
-
FC
-
Cesena, FC, Italy, 47522
- Active, not recruiting
- UO Microbiologia,Centro Servizi Pievesestina, AUSL Romagna
-
Meldola, FC, Italy, 47014
- Recruiting
- Irst Irccs
-
Contact:
- Giovanni Martinelli, Prof
- Email: giovanni.martinelli@irst.emr.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
|
serological test assessing IgM and IgG directed against SARS-CoV-2
Molecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab
Analysis of serum chemistry factors and coagulation panel in blood samples
|
COVID-19 patients
patients with confirmed diagnosis of COVID-19
|
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
Collaborators
Investigators
- Principal Investigator: Giovanni Martinelli, Prof., Irst Irccs
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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