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.
NCT ID: NCT04345315
Last Updated: 2020-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2020-03-27
2022-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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
serological test assessing IgM and IgG directed against SARS-CoV-2
Rapid molecular test
Molecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab
serum chemistry analysis
Analysis of serum chemistry factors and coagulation panel in blood samples
COVID-19 patients
patients with confirmed diagnosis of COVID-19
Next generation Sequencing (NGS) analysis
analysis of genetic variability of virus and host
Interventions
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serological test
serological test assessing IgM and IgG directed against SARS-CoV-2
Rapid molecular test
Molecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab
Next generation Sequencing (NGS) analysis
analysis of genetic variability of virus and host
serum chemistry analysis
Analysis of serum chemistry factors and coagulation panel in blood samples
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
Yes
Sponsors
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AUSL Romagna
UNKNOWN
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
OTHER
Responsible Party
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Principal Investigators
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Giovanni Martinelli, Prof.
Role: PRINCIPAL_INVESTIGATOR
IRST IRCCS
Locations
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UO Microbiologia,Centro Servizi Pievesestina, AUSL Romagna
Cesena, FC, Italy
Irst Irccs
Meldola, FC, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRSTB113
Identifier Type: -
Identifier Source: org_study_id
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