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

NCT ID: NCT04407143

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1980 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-15

Study Completion Date

2022-05-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer COVID Corona Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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lung cancer+COVID-19

Lung cancer patients infected by COVID-19

IgG test

Intervention Type DIAGNOSTIC_TEST

IgG+ blood test by ELISA method.

Interventions

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IgG test

IgG+ blood test by ELISA method.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación GECP

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariano Provencio, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Puerta de Hierro de Majadahonda de Madrid

Locations

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Complejo Hospitalario de A Coruña

A Coruña, A Coruña, Spain

Site Status

Hospital General Universitario de Elche

Elche, Alicante, Spain

Site Status

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Site Status

ICO Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital Universitario de Burgos

Burgos, Burgos, Spain

Site Status

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Site Status

Hospital Dr. Josep Trueta

Girona, Girona, Spain

Site Status

Hospital Universitario Insular de Gran canaria

Las Palmas de Gran Canaria, Gran Canaria, Spain

Site Status

Complejo Hospitalario de Jaén

Jaén, Jaén, Spain

Site Status

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Site Status

Hospital Universitario La Paz

Madrid, Madrid, Spain

Site Status

Hospital Puerta de Hierro

Madrid, Madrid, Spain

Site Status

Clínica Universidad de Navarra

Madrid, Madrid, Spain

Site Status

Hospital de Sanchinarro

Madrid, Madrid, Spain

Site Status

Hospital Severo Ochoa

Madrid, Madrid, Spain

Site Status

Hospital Universitario Infanta Cristina

Madrid, Madrid, Spain

Site Status

Hospital Universitario de Torrejón

Torrejón, Madrid, Spain

Site Status

Hospital Universitario Son Llàtzer

Palma de Mallorca, Mallorca, Spain

Site Status

Hospital General Universitario de Málaga

Málaga, Málaga, Spain

Site Status

Complexo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Site Status

Hospital Virgen del Rocío

Seville, Sevilla, Spain

Site Status

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Site Status

Hospital Universitari i Politécnic La Fe

Valencia, Valencia, Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Site Status

Hospital General de Valencia

Valencia, Valencia, Spain

Site Status

Hospital Universitario Dr. Peset

Valencia, Valencia, Spain

Site Status

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, Spain

Site Status

Hospital La Esperanza

A Coruña, , Spain

Site Status

Hospital Universitario de Ferrol

A Coruña, , Spain

Site Status

Hospital Virgen de los Lirios

Alicante, , Spain

Site Status

Hospital Germans Trias i Pujol

Badalona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitari Dexeus

Barcelona, , Spain

Site Status

Hospital Universitario Cruces

Bilbao, , Spain

Site Status

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Site Status

Hospital Universitario Puerto Real

Cadiz, , Spain

Site Status

Hospital Universitario San Pedro de Alcántara

Cáceres, , Spain

Site Status

Hospital General La Mancha Centro

Ciudad Real, , Spain

Site Status

Hospital Universitario de Vinalopó

Elche, , Spain

Site Status

Hospital Universitario de Guadalajara

Guadalajara, , Spain

Site Status

Complejo Asistencial Universitario de León

León, , Spain

Site Status

Hospital universitari Arnau de Vilanova

Lleida, , Spain

Site Status

Hospital San Pedro

Logroño, , Spain

Site Status

Hospital Universitario Lucus Augusti

Lugo, , Spain

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Hospital Universitario de Móstoles

Madrid, , Spain

Site Status

Hospital Universitario del Henares

Madrid, , Spain

Site Status

Hospital Universitario Fundación Alcorcón

Madrid, , Spain

Site Status

Hospital Universitario Infanta Leonor

Madrid, , Spain

Site Status

Hospital Universitario Infanta Sofía

Madrid, , Spain

Site Status

Hospital Universitario Príncipe de Asturias

Madrid, , Spain

Site Status

Hospital Costa del Sol

Málaga, , Spain

Site Status

Complejo Hospitalario Universitario de Ourense Santa María Nai

Ourense, , Spain

Site Status

Hospital Universitario Son Espases

Palma de Mallorca, , Spain

Site Status

Clínica Universidad de Navarra

Pamplona, , Spain

Site Status

Complejo Hospitalario de Navarra

Pamplona, , Spain

Site Status

Hospital Universitario Sant Joan de Reus

Reus, , Spain

Site Status

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status

Hospital Universitario de Canarias

Santa Cruz de Tenerife, , Spain

Site Status

Hospital General de Segovia

Segovia, , Spain

Site Status

Hospital Sant Pau i Santa Tecla

Tarragona, , Spain

Site Status

Hospital Arnau de Vilanova

Valencia, , Spain

Site Status

Hospital de Manises

Valencia, , Spain

Site Status

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Lluís Alcanyís

Valencia, , Spain

Site Status

Hospital Universitario Río Ortega

Valladolid, , Spain

Site Status

Complejo Hospitalario Zamora

Zamora, , Spain

Site Status

Countries

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Spain

References

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Provencio M, Estival A, Franco F, Lopez-Vivanco G, Saigi M, Arasanz H, Diz P, Carcereny E, Garcia J, Aguado C, Mosquera J, Iruarrizaga E, Majem M, Bosch-Barrera J, Mielgo-Rubio X, Guirado M, Juan-Vidal O, Blasco A, Lucia Gozalvez C, Del Barrio A, De Portugal T, Lopez-Martin A, Serrano G, Campos B, Rubio J, Catot S, Esteban B, Marti-Ciriquian JL, Del Barco E, Calvo V; Spanish Lung Cancer Group (SLGC/GECP). Immunogenicity of COVID-19 vaccines in lung cancer patients. Lung Cancer. 2023 Oct;184:107323. doi: 10.1016/j.lungcan.2023.107323. Epub 2023 Aug 9.

Reference Type DERIVED
PMID: 37639820 (View on PubMed)

Provencio M, Rodriguez-Abreu D, Ortega AL, Serrano G, Aguado C, Franco F, Gutierrez V, Lopez Vivanco G, Guirado M, Benitez G, Estival A, Calvo V, Jimenez B, Arasanz H, Coves J, Majem M, Massuti B, Vazquez S, Juan-Vidal O, Collazo-Lorduy A, Gozalvez CL, Del Barco E, Rosero A, Bosch-Barrerra J, Moreno MA, Mielgo-Rubio X, Villa JC, Lopez-Martin A, Cordoba JF, de Asis Aparisi F, Zafra M, Mosquera J, Perez Altozano J, Nadal E, Catot S, Balsalobre J, de Portugal T, Martin P, Cuesta de Juan S, Cobo M. Seroprevalence and immunological memory against SARS-CoV-2 in lung cancer patients: the SOLID study. Transl Lung Cancer Res. 2022 Jan;11(1):53-63. doi: 10.21037/tlcr-21-504.

Reference Type DERIVED
PMID: 35242627 (View on PubMed)

Related Links

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http://www.gecp.org

Web page of the sponsor where users can find more information about Fundación GECP studies

Other Identifiers

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GECP 20/04_SOLID

Identifier Type: -

Identifier Source: org_study_id

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