Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer
- Conditions
- COVID, Cancer
- Interventions
- Other: mortality
- Registration Number
- NCT04457570
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description exposed patients mortality 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. control patients mortality 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
- Primary Outcome Measures
Name Time Method mortality for SARS-CoV-2 infection 30 days mortality within 30 days after the hospitalization for the SARS-CoV-2 infection
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Institut de Cancérologie de la Loire Lucien Neurwirth
🇫🇷Saint-Priest-en-Jarez, France
Centre Leon Berard
🇫🇷Lyon, France
Centre de lutte contre le Cancer JEAN PERRIN
🇫🇷Clermont-Ferrand, France
Centre Hospitalier Uniersitaire de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Centre Hospitalier Universitaire de St Etienne
🇫🇷Saint-Étienne, France