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

Sponsor
Fundación GECP (Other)
Overall Status
Completed
CT.gov ID
NCT04407143
Collaborator
(none)
1,980
68
25.5
29.1
1.1

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
  • Diagnostic Test: IgG test

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

Study Type:
Observational
Actual Enrollment :
1980 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection
Actual Study Start Date :
Apr 15, 2020
Actual Primary Completion Date :
Apr 30, 2022
Actual Study Completion Date :
May 30, 2022

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

  1. 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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. Patients diagnosed with lung cancer at any stage of the disease

  2. Age ≥ 18

  3. 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

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.
Responsible Party:
Fundación GECP
ClinicalTrials.gov Identifier:
NCT04407143
Other Study ID Numbers:
  • GECP 20/04_SOLID
First Posted:
May 29, 2020
Last Update Posted:
Jun 3, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundación GECP
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2022