Observational Study on the Effectiveness and Safety of Vaccination Anti-SARS-CoV2 in Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 794
- 试验地点
- 51
- 主要终点
- Determine the efficacy of the COVID19 vaccine
研究概览
简要总结
Observational and multicenter retrospective study of data collection in hospital centers throughout the Spanish geography.
This study aims to be nationwide in order to study general common variables of the patients, as well as the correlation with the cancer treatments received.
详细描述
Observational and multicenter retrospective study of data collection in hospital centers throughout the Spanish geography.
This study aims to be nationwide in order to study general common variables of the patients, as well as the correlation with the cancer treatments received.
Disease and study population Patients with lung cancer of any histology and stage who receive an anti-COVID-19 vaccine approved by the health authorities. Patients would be eligible whether they have suffered from SARS-CoV2 infection or have not had COVID19.
The study will be extended to all the centers of the Spanish Lung Cancer Group, more than 170 centers and 500 professionals, and it is expected that around 500 cases will be collected.
The main objective of the study is to collect the safety and efficacy of the vaccine against SARS-CoV-2 in cancer patients, as well as its potential interactions with antineoplastic therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients diagnosed with lung cancer of any stage and histology who have or have not contracted COVID-19 and who have been vaccinated with an EMA approved COVID-19 vaccine.
- •Age equal to or greater than 18 years
排除标准
- •Patients who have not received an EMA approved COVID-19 vaccine.
研究组 & 干预措施
Study group
Patients with lung cancer of any histology and stage who receive an anti-COVID-19 vaccine approved by the health authorities. Patients would be eligible whether they have suffered from SARS-CoV2 infection or have not had COVID19.
干预措施: COVID-19 vaccine (Drug)
结局指标
主要结局
Determine the efficacy of the COVID19 vaccine
时间窗: From the date of the last dose of the vaccine until three months later
Analyze patients who do not become infected with COVID-19 after being vaccinated
Incidence of COVID-19 vaccine-Emergent Adverse Events (Safety and Tolerability)
时间窗: From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
次要结局
- Determine the frequency of COVID-19 and its severity in lung cancer patients receiving the anti-COVID vaccine(From the date of the last dose of the vaccine until three months later)
- Incidence of COVID-19 vaccine-Emergent Adverse Events and toxicities associated with antineoplastic treatments (Safety and Tolerability)(From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug)