Study of the Immunity of Patients With Lung Cancer and COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
Observational, retrospective data collection and prospective IgG analysis, and multicenter study. The main objective of the study is th description of the characteristics and evolution of patients with lung cancer who have acquired COVID-19 infection. For the identification of patients who contract COVID-19 infection, the IgG+ blood test by ELISA method will be used.

Detailed Description
-----------------
Non-post-authorization study, retrospective of data collection and prospective of IgG analysis, observational and multicenter. The study will be extended to all the sites of the Spanish Lung Cancer Group, more than 170 centers and 500 professionals, and it is expected that around 1,500 IgG tests will be carried out. The study has three phases: The scope of phase I is the identification of acquired immunity (IgG) in patients with lung cancer, whether or not they have presented symptoms of having suffered from COVID19. In addition, the description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection will be carried out. For the identification of patients who contract COVID-19 infection, the IgG+ test in blood will be used by ELISA method. The scope of phase II is the confirmation of the presence of antibodies (IgG) in patients who tested positive in Phase I of the study a few weeks after the first diagnosis made through the SOLID study. The scope of phase III is the confirmation of the presence of antibodies (IgG) in patients with lung cancer who have been vaccinated with any of the available and authorized vaccines for SARS-COV2 and 6 months after said administration.

Official Title
-----------------
Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection

Conditions
-----------------
Lung Cancer, COVID, Corona Virus Infection

Intervention / Treatment
-----------------
* Diagnostic Test: IgG test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with lung cancer at any stage of the disease Age ≥ 18 Patients who have signed the informed consent for this study Exclusion Criteria: 1. Patients who have not signed or do not wish to sign the informed consent for this study

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lung cancer+COVID-19<br>Lung cancer patients infected by COVID-19 | Diagnostic Test: IgG test<br>* IgG+ blood test by ELISA method.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the characteristics of patients | Description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection. | From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of antibodies (IgG) at 6 months after SARS-COV2 vaccines | Confirmation of the presence of antibodies (IgG) in patients with lung cancer who have been vaccinated with any of the available and authorized vaccines for SARS-COV2 and 6 months after such administration. | From the date of complete SARS-COV2 vaccination administration until 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IgG, coronavirus, COVID-19, lung cancer