COVID-19CORSANCT04345315
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.
An observational study of COVID-19 and SARS-CoV-2, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- serological test, Rapid molecular test and Next generation Sequencing (NGS) analysis
- How many people
- 500 participants
- Where
- 2 sitesItaly
- Study dates
- 27 Mar 2020to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 1 recruiting
- Active, not recruiting
UO Microbiologia,Centro Servizi Pievesestina, AUSL Romagna
Cesena, FC, 47522
- Recruiting
Irst Irccs
Meldola, FC, 47014
Giovanni Martinelli, Prof, giovanni.martinelli@irst.emr.it
About this study
Official title: 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.
Read the 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).
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- serological test, Rapid molecular test, Next generation Sequencing (NGS) analysis, serum chemistry analysis
- Keywords
- SARS-CoV-2, COVID-19, cancer, IgM-IgG, seroprevalence
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serological testOther
serological test assessing IgM and IgG directed against SARS-CoV-2
Rapid molecular testOther
Molecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab
Next generation Sequencing (NGS) analysisGenetic
analysis of genetic variability of virus and host
serum chemistry analysisOther
Analysis of serum chemistry factors and coagulation panel in blood samples
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: serological test; Other: Rapid molecular test; Other: serum chemistry analysis | |
| COVID-19 patients | patients with confirmed diagnosis of COVID-19 Receives: Genetic: Next generation Sequencing (NGS) analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation
IgG and IgM antibodies evaluation over time
Measured: 12 months
methods comparison
Make a comparison between different serological investigation methods and rapid molecular methods becoming available
Measured: 24 months
correlation between biochemical and coagulative factors with SARS-CoV-2 positivity.
To evaluate correlation between biochemical and coagulative factors with SARS-CoV-2 positivity
Measured: 24 months
phylogenetic map
Building a phylogenetic map of an epidemic Italian macro-region
Measured: 24 months
interactions between the virus and host cells
Evaluate the spectrum of possible interactions between the virus and host cells, considering their genetic variability / instability in patients diagnosed with COVID-19
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start27 Mar 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- AUSL Romagna
- Responsible party
- Sponsor
- Investigators
- Giovanni Martinelli, Prof., Principal investigator, IRST IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345315
- Sponsor's protocol ID
- IRSTB113
- Acronym
- CORSA
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlative Study on Cancer Patients and Healthcare Professionals Exposed to SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04345315
- Acronym / sponsor ID
- CORSA / IRSTB113
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- SARS-CoV-2, COVID-19, cancer, IgM-IgG, seroprevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Collaborators
- AUSL Romagna
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asymptomatic population at high risk of infection | – | Other: serological test, Other: Rapid molecular test, Other: serum chemistry analysishealthy 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 |
| COVID-19 patients | – | Genetic: Next generation Sequencing (NGS) analysispatients with confirmed diagnosis of COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serological testserological test assessing IgM and IgG directed against SARS-CoV-2 | Other | asymptomatic population at high risk of infection |
| Rapid molecular testMolecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab | Other | asymptomatic population at high risk of infection |
| Next generation Sequencing (NGS) analysisanalysis of genetic variability of virus and host | Genetic | COVID-19 patients |
| serum chemistry analysisAnalysis of serum chemistry factors and coagulation panel in blood samples | Other | asymptomatic population at high risk of infection |
Primary outcome
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
5 secondary outcomes
Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation
Time frame: 12 months
methods comparison
Time frame: 24 months
correlation between biochemical and coagulative factors with SARS-CoV-2 positivity.
Time frame: 24 months
phylogenetic map
Time frame: 24 months
interactions between the virus and host cells
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Martinelli, Prof. principal investigator
IRST IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Martinelli, Prof (+39 0543 739100, giovanni.martinelli@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epidemiology (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.