ONCOVID-AURA: Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- mortality for SARS-CoV-2 infection
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
mortality for SARS-CoV-2 infection
时间窗: 30 days
mortality within 30 days after the hospitalization for the SARS-CoV-2 infection
次要结局
未报告次要终点