Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer

  • STATUS
    Recruiting
  • days left to enroll
    79
  • participants needed
    600
  • sponsor
    Hospices Civils de Lyon
Updated on 12 July 2020
Investigator
Julien PERON, Dr.
Primary Contact
Institut de Canc rologie de la Loire Lucien Neurwirth (0.0 mi away) Contact
+1 other location

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

Details
Treatment Mortality
Clinical Study IdentifierNCT04457570
SponsorHospices Civils de Lyon
Last Modified on12 July 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have COVID, Cancer?
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
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