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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)

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ClinicalTrials.gov Identifier: NCT04345315
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
AUSL Romagna
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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.


Condition or disease Intervention/treatment
COVID-19 SARS-CoV-2 Other: serological test Other: Rapid molecular test Genetic: Next generation Sequencing (NGS) analysis Other: serum chemistry analysis

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).

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Correlative Study on Cancer Patients and Healthcare Professionals Exposed to SARS-CoV-2 Infection
Actual Study Start Date : March 27, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation [ Time Frame: 12 months ]
    IgG and IgM antibodies evaluation over time

  2. methods comparison [ Time Frame: 24 months ]
    Make a comparison between different serological investigation methods and rapid molecular methods becoming available

  3. 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

  4. phylogenetic map [ Time Frame: 24 months ]
    Building a phylogenetic map of an epidemic Italian macro-region

  5. 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


Biospecimen Retention:   Samples With DNA
oropharyngeal and nasal swabs and blood samples will be collected


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345315


Contacts
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Contact: Giovanni Martinelli, Prof +39 0543 739100 giovanni.martinelli@irst.emr.it
Contact: Oriana Nanni, Dr +39 0543 739100 oriana.nanni@irst.emr.it

Locations
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Italy
UO Microbiologia,Centro Servizi Pievesestina, AUSL Romagna Active, not recruiting
Cesena, FC, Italy, 47522
Irst Irccs Recruiting
Meldola, FC, Italy, 47014
Contact: Giovanni Martinelli, Prof       giovanni.martinelli@irst.emr.it   
Sponsors and Collaborators
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
AUSL Romagna
Investigators
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Principal Investigator: Giovanni Martinelli, Prof. IRST IRCCS
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Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier: NCT04345315    
Other Study ID Numbers: IRSTB113
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori:
SARS-CoV-2
COVID-19
cancer
IgM-IgG
seroprevalence
Additional relevant MeSH terms:
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Infection