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.
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. The data collection will take place throughout the year 2021
Study Type
OBSERVATIONAL
Enrollment
794
Lung cancer patients will receive an anti-COVID19 vaccine approved by the European Medicines Agency according to the guidelines approved by the regulatory authorities
Determine the efficacy of the COVID19 vaccine
Analyze patients who do not become infected with COVID-19 after being vaccinated
Time frame: From the date of the last dose of the vaccine until three months later
Incidence of COVID-19 vaccine-Emergent Adverse Events (Safety and Tolerability)
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
Time frame: From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug
Determine the frequency of COVID-19 and its severity in lung cancer patients receiving the anti-COVID vaccine
Analyze patients who become infected with COVID-19 after being vaccinated
Time frame: 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)
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
Time frame: From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug
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Complejo Hospitalario Universitario De Santiago
Santiago de Compostela, A Coruña, Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital De Torrevieja
Torrevieja, Alicante, Spain
Hospital Universitario Araba-Sede Txagorritxu
Vitoria-Gasteiz, Araba, Spain
Hospital Germans Trias I Pujol
Badalona, Barcelona, Spain
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital De Mataro
Mataró, Barcelona, Spain
Hospital Galdakao-Usansolo
Galdakao, Bizkaia, Spain
Hospital La Mancha Centro
Alcázar de San Juan, Ciudad Real, Spain
Hospital Universitario Jerez De La Frontera
Jerez de la Frontera, Cádiz, Spain
...and 41 more locations