Clinical trial NCT04457570: Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer
Official title: ONCOVID-AURA: Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID, Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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


Eligibility criteria: 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

Primary outcomes:
measure: mortality for SARS-CoV-2 infection
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre de lutte contre le Cancer JEAN PERRIN
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Uniersitaire de Clermont-Ferrand
city: Lyon
country: France
facility: Centre Leon Berard
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie de la Loire Lucien Neurwirth
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de St Etienne
Study officials:
References: