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
Aperçu de l'étude
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
-
Clermont-Ferrand, France
- Recrutement
- Centre de Lutte Contre le Cancer Jean Perrin
-
Contact:
- PERRON Julien, MD
-
Clermont-Ferrand, France
- Recrutement
- Centre Hospitalier Uniersitaire de Clermont-Ferrand
-
Contact:
- BAY Jacques Olivier, MD
-
Lyon, France
- Recrutement
- Centre Léon Bérard
-
Contact:
- PEROL David, Pr
-
Saint-Priest-en-Jarez, France
- Recrutement
- Institut de Cancérologie de la Loire Lucien Neurwirth
-
Contact:
- FOURNEL Pierre, MD
-
Saint-Étienne, France
- Recrutement
- Centre hospitalier universitaire de St Etienne
-
Contact:
- Botelho-Nevers Elisabeth, PR
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
mortality for SARS-CoV-2 infection
Délai: 30 days
|
mortality within 30 days after the hospitalization for the SARS-CoV-2 infection
|
30 days
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 69HCL20_0509
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .