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
Studieoversikt
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Clermont-Ferrand, Frankrike
- Rekruttering
- Centre de Lutte Contre le Cancer Jean Perrin
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Ta kontakt med:
- PERRON Julien, MD
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Clermont-Ferrand, Frankrike
- Rekruttering
- Centre Hospitalier Uniersitaire de Clermont-Ferrand
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Ta kontakt med:
- BAY Jacques Olivier, MD
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Lyon, Frankrike
- Rekruttering
- Centre Leon Berard
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Ta kontakt med:
- PEROL David, Pr
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Saint-Priest-en-Jarez, Frankrike
- Rekruttering
- Institut de Cancérologie de la Loire Lucien Neurwirth
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Ta kontakt med:
- FOURNEL Pierre, MD
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Saint-Étienne, Frankrike
- Rekruttering
- Centre hospitalier universitaire de St Etienne
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Ta kontakt med:
- Botelho-Nevers Elisabeth, PR
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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mortality for SARS-CoV-2 infection
Tidsramme: 30 days
|
mortality within 30 days after the hospitalization for the SARS-CoV-2 infection
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30 days
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 69HCL20_0509
Plan for individuelle deltakerdata (IPD)
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