Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer (ONCOVID-AURA)
ONCOVID-AURA: Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer
Context:
Based on currently available data, most of national health authorities and consensus expert groups have written guidelines for the management of cancer patients in the context of COVID. However, the preparation of these guidelines was limited by the scarcity of solid epidemiological data. For example, the experts were uncomfortable to formulate precise guidelines on which anti-cancer treatment should be interrupted or replaced, on which patients, and how to adapt supportive drug prescriptions.
Objectives :
- To measure the excess risk of mortality and morbidity of patients with a history of cancer among patients hospitalized for a SARS-CoV-2 infection.
- To identify factors associated with the risk of death and morbidity among patients with cancer.
Methodology:
Retrospective inclusion of n=200 cancer patients hospitalized for COVID and n=400 matched (based on age, gender, and comorbidity) non-cancer patients hospitalized for COVID. Two analyses will be performed (after the inclusion of n=100 and n=200 patients with cancer). A logistic modeling of the odds ratio of death associated to the exposition factor (i.e. cancer) and adjusted for the matching parameters (age, gender, comorbidities) will be proposed.
We will then look for the factors (related to the patients, the cancer or the treatment) that modify the odds radio.
Expected results:
The data generated will help the medical and scientific community to evaluate the increasing risk of cancer patients infected by SARS-CoV-2 compared to the non-cancer population, to identify patients at higher risk of severe infection, but also the anticancer treatments associated with an increased risk of severe infections.
Impact:
These data will contribute to guide the future recommendations concerning cancer patient's care in the context of the COVID-19 pandemic. There is a real risk that the SARS-CoV epidemic, or other respiratory viruses epidemic, will become recurrent in the future. Thus, it is of crucial importance for now and for the future to know which are the major factors associated with severe infections
Studie Overzicht
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Clermont-Ferrand, Frankrijk
- Werving
- Centre de Lutte Contre le Cancer Jean Perrin
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Contact:
- PERRON Julien, MD
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Clermont-Ferrand, Frankrijk
- Werving
- Centre Hospitalier Uniersitaire de Clermont-Ferrand
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Contact:
- BAY Jacques Olivier, MD
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Lyon, Frankrijk
- Werving
- Centre Léon Bérard
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Contact:
- PEROL David, Pr
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Saint-Priest-en-Jarez, Frankrijk
- Werving
- Institut de Cancérologie de la Loire Lucien Neurwirth
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Contact:
- FOURNEL Pierre, MD
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Saint-Étienne, Frankrijk
- Werving
- Centre hospitalier universitaire de St Etienne
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Contact:
- Botelho-Nevers Elisabeth, PR
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Two categories of patients will be defined: the "exposed patients" are patients with cancer that are hospitalized in one of the participating centers for a SARS-CoV-2 infection. A patient will be considered as an "exposed patient" if he/she had a surgical procedure or a medical treatment for cancer in the past 5 years preceding the SARS-CoV-2 infection.
The "control patients" are all of the patients without cancer that are hospitalized in one of the participating centers for a SARS-CoV-2 infection.
In both cohorts, a positive laboratory test (RT-PCR) proving the SARS-CoV-2 infection will be mandatory.
Beschrijving
Inclusion Criteria:
- EXPOSED PATIENTS:
- Age > 18 years old
- Patients with a confirmed diagnosis of solid or hematologic cancer
- Patients who received their last anticancer treatment (surgery, systemic treatments or other localized treatment) in the past 5 years before SARS-CoV-2 infection
- Positive laboratory test (RT-PCR) proving the SARS-CoV-2 infection
- Patients hospitalized in one of the participating centers because of the SARS-CoV-2 infection
- Patients who are not opposed in participating to the ONCOVID-AURA study
CONTROL PATIENTS:
- Age > 18 years old
- Patients who have no cancer (neither solid nor hematologic tumors) or patients who received their last anticancer treatments more than five years before the SARS-CoV-2 infection
- Positive laboratory test (RT-PCR) proving the SARS-CoV-2 infection
- Patients hospitalized in one of the participating centers because of the SARS-CoV-2 infection
- Patients who are not opposed in participating to the ONCOVID-AURA study
Exclusion Criteria:
- none
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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exposed patients
The "exposed patients" are patients with cancer that are hospitalized in one of the participating centers for a SARS-CoV-2 infection.
A patient will be considered as an "exposed patient" if he/she had a surgical procedure or a medical treatment for cancer in the past 5 years preceding the SARS-CoV-2 infection.
|
To measure the excess risk of mortality of patients with a history of cancer among patients hospitalized for a SARS-CoV-2 infection
|
|
control patients
The "control patients " are all of the patients without cancer that are hospitalized in one of the participating centers for a SARS-CoV-2 infection
|
To measure the excess risk of mortality of patients with a history of cancer among patients hospitalized for a SARS-CoV-2 infection
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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mortality for SARS-CoV-2 infection
Tijdsspanne: 30 days
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mortality within 30 days after the hospitalization for the SARS-CoV-2 infection
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30 days
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 69HCL20_0509
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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