SOLID: Study of the Immunity of Patients With Lung Cancer and COVID-19 Infection
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
lung cancer+COVID-19 Lung cancer patients infected by COVID-19 |
Diagnostic Test: IgG test
IgG+ blood test by ELISA method.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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:
- Patients who have not signed or do not wish to sign the informed consent for this study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hospital General Universitario de Elche | Elche | Alicante | Spain | 03203 |
2 | ICO Hospitalet | Hospitalet de Llobregat | Barcelona | Spain | 08908 |
3 | Hospital Universitario Insular de Gran canaria | Las Palmas De Gran Canaria | Gran Canaria | Spain | 35016 |
4 | Hospital Universitario de Torrejón | Torrejón | Madrid | Spain | |
5 | Hospital Universitario Son Llàtzer | Palma De Mallorca | Mallorca | Spain | 07198 |
6 | Complexo Hospitalario Universitario de Vigo | Vigo | Pontevedra | Spain | 36036 |
7 | Complejo Hospitalario de A Coruña | A Coruña | Spain | 15006 | |
8 | Hospital La Esperanza | A Coruña | Spain | ||
9 | Hospital Universitario de Ferrol | A Coruña | Spain | ||
10 | Hospital Virgen de los Lirios | Alicante | Spain | ||
11 | Hospital Germans Trias i Pujol | Badalona | Spain | ||
12 | Hospital Clínic de Barcelona | Barcelona | Spain | 08036 | |
13 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | ||
14 | Hospital Universitari Dexeus | Barcelona | Spain | ||
15 | Hospital Universitario Cruces | Bilbao | Spain | ||
16 | Hospital Universitario de Burgos | Burgos | Spain | ||
17 | Hospital Universitario Puerto Real | Cadiz | Spain | ||
18 | Hospital General La Mancha Centro | Ciudad Real | Spain | ||
19 | Hospital Universitario San Pedro de Alcántara | Cáceres | Spain | ||
20 | Hospital Universitario Puerta del Mar | Cádiz | Spain | ||
21 | Hospital Universitario Reina Sofía | Córdoba | Spain | 14004 | |
22 | Hospital Universitario de Vinalopó | Elche | Spain | ||
23 | Hospital Dr. Josep Trueta | Girona | Spain | 17007 | |
24 | Hospital Universitario de Guadalajara | Guadalajara | Spain | ||
25 | Complejo Hospitalario de Jaén | Jaén | Spain | 23007 | |
26 | Complejo Asistencial Universitario de León | León | Spain | ||
27 | Hospital universitari Arnau de Vilanova | Lleida | Spain | ||
28 | Hospital San Pedro | Logroño | Spain | ||
29 | Hospital Universitario Lucus Augusti | Lugo | Spain | ||
30 | Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | 28040 | |
31 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
32 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
33 | Hospital Puerta de Hierro | Madrid | Spain | 28222 | |
34 | Clínica Universidad de Navarra | Madrid | Spain | ||
35 | Hospital de Sanchinarro | Madrid | Spain | ||
36 | Hospital General Universitario Gregorio Marañón | Madrid | Spain | ||
37 | Hospital Severo Ochoa | Madrid | Spain | ||
38 | Hospital Universitario de Móstoles | Madrid | Spain | ||
39 | Hospital Universitario del Henares | Madrid | Spain | ||
40 | Hospital Universitario Fundación Alcorcón | Madrid | Spain | ||
41 | Hospital Universitario Infanta Cristina | Madrid | Spain | ||
42 | Hospital Universitario Infanta Leonor | Madrid | Spain | ||
43 | Hospital Universitario Infanta Sofía | Madrid | Spain | ||
44 | Hospital Universitario Príncipe de Asturias | Madrid | Spain | ||
45 | Hospital General Universitario de Málaga | Málaga | Spain | 29010 | |
46 | Hospital Costa del Sol | Málaga | Spain | ||
47 | Complejo Hospitalario Universitario de Ourense Santa María Nai | Ourense | Spain | ||
48 | Hospital Universitario Son Espases | Palma De Mallorca | Spain | ||
49 | Clínica Universidad de Navarra | Pamplona | Spain | ||
50 | Complejo Hospitalario de Navarra | Pamplona | Spain | ||
51 | Hospital Universitario Sant Joan de Reus | Reus | Spain | ||
52 | Hospital Universitario de Salamanca | Salamanca | Spain | ||
53 | Hospital Universitario de Canarias | Santa Cruz De Tenerife | Spain | ||
54 | Hospital General de Segovia | Segovia | Spain | ||
55 | Hospital Virgen del Rocío | Sevilla | Spain | 41013 | |
56 | Hospital Sant Pau i Santa Tecla | Tarragona | Spain | ||
57 | Hospital Universitario Nuestra Señora de Candelaria | Tenerife | Spain | ||
58 | Hospital Universitari i Politécnic La Fe | Valencia | Spain | 46009 | |
59 | Hospital Clínico Universitario de Valencia | Valencia | Spain | 46010 | |
60 | Hospital General de Valencia | Valencia | Spain | 46014 | |
61 | Hospital Arnau de Vilanova | Valencia | Spain | ||
62 | Hospital de Manises | Valencia | Spain | ||
63 | Hospital General Universitario de Valencia | Valencia | Spain | ||
64 | Hospital Lluís Alcanyís | Valencia | Spain | ||
65 | Hospital Universitario Dr. Peset | Valencia | Spain | ||
66 | Hospital Clínico Universitario de Valladolid | Valladolid | Spain | 47003 | |
67 | Hospital Universitario Río Ortega | Valladolid | Spain | ||
68 | Complejo Hospitalario Zamora | Zamora | Spain |
Sponsors and Collaborators
- Fundación GECP
Investigators
- Principal Investigator: Mariano Provencio, MD, Hospital Puerta de Hierro de Majadahonda de Madrid
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- GECP 20/04_SOLID