Study of the Immunity of Patients With Lung Cancer and COVID-19 Infection
- Conditions
- Corona Virus InfectionLung CancerCOVID
- Registration Number
- NCT04407143
- Lead Sponsor
- Fundación GECP
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1980
- Patients diagnosed with lung cancer at any stage of the disease
- Age ≥ 18
- Patients who have signed the informed consent for this study
- Patients who have not signed or do not wish to sign the informed consent for this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Description of the characteristics of patients From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeks Description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection.
- Secondary Outcome Measures
Name Time Method Detection of antibodies (IgG) at 6 months after SARS-COV2 vaccines From the date of complete SARS-COV2 vaccination administration until 6 month 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.
Trial Locations
- Locations (67)
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
ICO Hospitalet
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Insular de Gran canaria
🇪🇸Las Palmas De Gran Canaria, Gran Canaria, Spain
Hospital Universitario de Torrejón
🇪🇸Torrejón, Madrid, Spain
Hospital Universitario Son Llàtzer
🇪🇸Palma De Mallorca, Mallorca, Spain
Complexo Hospitalario Universitario de Vigo
🇪🇸Vigo, Pontevedra, Spain
Complejo Hospitalario de A Coruña
🇪🇸A Coruña, Spain
Hospital La Esperanza
🇪🇸A Coruña, Spain
Hospital Universitario de Ferrol
🇪🇸A Coruña, Spain
Hospital Virgen de los Lirios
🇪🇸Alicante, Spain
Scroll for more (57 remaining)Hospital General Universitario de Elche🇪🇸Elche, Alicante, Spain