Anti-SARS-COV2 Vaccination Study in Lung Cancer Patients

Study Overview
=================
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

Official Title
-----------------
Observational Study on the Effectiveness and Safety of Vaccination Anti-SARS-CoV2 in Patients With Lung Cancer

Conditions
-----------------
Lung Cancer, Covid19

Intervention / Treatment
-----------------
* Drug: COVID-19 vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Patients who have not received an EMA approved COVID-19 vaccine.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>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. | Drug: COVID-19 vaccine<br>* Lung cancer patients will receive an anti-COVID19 vaccine approved by the European Medicines Agency according to the guidelines approved by the regulatory authorities<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy of the COVID19 vaccine | Analyze patients who do not become infected with COVID-19 after being vaccinated | 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. | From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 vaccine