Anti-SARS-COV2 Vaccination Study in Lung Cancer Patients
- Registration Number
- NCT05009030
- Lead Sponsor
- Fundación GECP
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 794
- 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
- Patients who have not received an EMA approved COVID-19 vaccine.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study group COVID-19 vaccine 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.
- Primary Outcome Measures
Name Time Method Determine the efficacy of the COVID19 vaccine 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) 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.
- Secondary Outcome Measures
Name Time Method 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 Analyze patients who become infected with COVID-19 after being vaccinated
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 Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
Trial Locations
- Locations (51)
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
🇪🇸Gasteiz / Vitoria, Araba, Spain
Hospital Germans Trias I Pujol
🇪🇸Badalona, Barcelona, Spain
ICO Hospitalet
🇪🇸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
Scroll for more (41 remaining)Complejo Hospitalario Universitario De Santiago🇪🇸Santiago De Compostela, A Coruña, Spain