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

NCT04457570 | Unknown

• 1 other identifier: 69HCL20_0509
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 5

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

Conditions

COVID, Cancer

Outcome Measures

Primary Outcomes (1)

• mortality for SARS-CoV-2 infection

  mortality within 30 days after the hospitalization for the SARS-CoV-2 infection

  30 days

Study Arms (2)

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.

Other: mortality

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

Other: mortality

Interventions

mortality OTHER

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; exposed patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (5)

Centre de lutte contre le Cancer JEAN PERRIN

Clermont-Ferrand, France

RECRUITING

Centre Hospitalier Uniersitaire de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Centre Leon Berard

Lyon, France

RECRUITING

Centre Hospitalier Universitaire de St Etienne

Saint-Etienne, France

RECRUITING

Institut de Cancérologie de la Loire Lucien Neurwirth

Saint-Priest-en-Jarez, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Mortality

Intervention Hierarchy (Ancestors)

Vital Statistics; Data Collection; Epidemiologic Methods; Investigative Techniques; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

PERRON Julien, MD

CONTACT

+33 (0)4 78 86 37 75; julien.peron@chu-lyon.fr

CALATTINI Sarah

CONTACT

+33 (0) 4 78 86 37 79; sara.calattini@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 7, 2020
• Study Start: June 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: February 15, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

FR (5)