Informations générales (source: ClinicalTrials.gov)
ONCOVID-AURA: Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer (ONCOVID-AURA)
Observational
Hospices Civils de Lyon (Voir sur ClinicalTrials)
juin 2020
février 2021
29 juin 2024
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
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre de lutte contre le Cancer JEAN PERRIN - Clermont-Ferrand - France | PERRON Julien, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de St Etienne - Saint-Étienne - France | Botelho-Nevers Elisabeth, PR | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Uniersitaire de Clermont-Ferrand - Clermont-Ferrand - France | BAY Jacques Olivier, MD | Contact (sur clinicalTrials) | |||
| Centre Leon Berard - Lyon - France | PEROL David, Pr | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de la Loire Lucien Neurwirth - Saint-Priest-en-Jarez - France | FOURNEL Pierre, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- none