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.

NCT04345315 | Unknown

• 1 other identifier: IRSTB113
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19; SARS-CoV-2

Keywords

SARS-CoV-2; COVID-19; cancer; IgM-IgG; seroprevalence

Outcome Measures

Primary Outcomes (1)

• epidemiology

  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 Outcomes (5)

• Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation

  12 months

• methods comparison

  24 months

• correlation between biochemical and coagulative factors with SARS-CoV-2 positivity.

  24 months

• phylogenetic map

  24 months

• interactions between the virus and host cells

  24 months

Study Arms (2)

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; Other: Rapid molecular test; Other: serum chemistry analysis

COVID-19 patients

patients with confirmed diagnosis of COVID-19

Genetic: Next generation Sequencing (NGS) analysis

Interventions

serological test OTHER

serological test assessing IgM and IgG directed against SARS-CoV-2

asymptomatic population at high risk of infection

Rapid molecular test OTHER

Molecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab

asymptomatic population at high risk of infection

Next generation Sequencing (NGS) analysis GENETIC

analysis of genetic variability of virus and host

COVID-19 patients

serum chemistry analysis OTHER

Analysis of serum chemistry factors and coagulation panel in blood samples

asymptomatic population at high risk of infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead
• AUSL Romagna: collaborator

Study Sites (2)

UO Microbiologia,Centro Servizi Pievesestina, AUSL Romagna

Cesena, FC, 47522, Italy

ACTIVE NOT RECRUITING

Irst Irccs

Meldola, FC, 47014, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

oropharyngeal and nasal swabs and blood samples will be collected

MeSH Terms

Conditions

COVID-19; Neoplasms

Interventions

Serologic Tests; High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Sequence Analysis; Genetic Techniques

Study Officials

• Giovanni Martinelli, Prof.

  IRST IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Martinelli, Prof

CONTACT

+39 0543 739100; giovanni.martinelli@irst.emr.it

Oriana Nanni, Dr

CONTACT

+39 0543 739100; oriana.nanni@irst.emr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: March 27, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2022
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)