Clinical trial NCT04407143: Study of the Immunity of Patients With Lung Cancer and COVID-19 Infection
Official title: Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
COVID
Corona Virus Infection
Keywords: IgG
coronavirus
COVID-19
lung cancer
Lead sponsor: Fundación GECP
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 1980
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have not signed or do not wish to sign the informed consent for this study

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.

Eligibility criteria: 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

Primary outcomes:
measure: Description of the characteristics of patients
timeFrame: From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeks
Secondary outcomes:
measure: Detection of antibodies (IgG) at 6 months after SARS-COV2 vaccines
timeFrame: From the date of complete SARS-COV2 vaccination administration until 6 month
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Hospitalet de Llobregat
country: Spain
facility: ICO Hospitalet
state: Barcelona
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran canaria
state: Gran Canaria
city: Torrejón
country: Spain
facility: Hospital Universitario de Torrejón
state: Madrid
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Llàtzer
state: Mallorca
city: Vigo
country: Spain
facility: Complexo Hospitalario Universitario de Vigo
state: Pontevedra
city: A Coruña
country: Spain
facility: Complejo Hospitalario de A Coruña
city: A Coruña
country: Spain
facility: Hospital La Esperanza
city: A Coruña
country: Spain
facility: Hospital Universitario de Ferrol
city: Alicante
country: Spain
facility: Hospital Virgen de los Lirios
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus
city: Bilbao
country: Spain
facility: Hospital Universitario Cruces
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Cadiz
country: Spain
facility: Hospital Universitario Puerto Real
city: Ciudad Real
country: Spain
facility: Hospital General La Mancha Centro
city: Cáceres
country: Spain
facility: Hospital Universitario San Pedro de Alcántara
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Elche
country: Spain
facility: Hospital Universitario de Vinalopó
city: Girona
country: Spain
facility: Hospital Dr. Josep Trueta
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
city: Lleida
country: Spain
facility: Hospital universitari Arnau de Vilanova
city: Logroño
country: Spain
facility: Hospital San Pedro
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital de Sanchinarro
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Severo Ochoa
city: Madrid
country: Spain
facility: Hospital Universitario de Móstoles
city: Madrid
country: Spain
facility: Hospital Universitario del Henares
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Alcorcón
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Sofía
city: Madrid
country: Spain
facility: Hospital Universitario Príncipe de Asturias
city: Málaga
country: Spain
facility: Hospital General Universitario de Málaga
city: Málaga
country: Spain
facility: Hospital Costa del Sol
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense Santa María Nai
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Reus
country: Spain
facility: Hospital Universitario Sant Joan de Reus
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Tarragona
country: Spain
facility: Hospital Sant Pau i Santa Tecla
city: Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Valencia
country: Spain
facility: Hospital Universitari i Politécnic La Fe
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital de Manises
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Lluís Alcanyís
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Valladolid
country: Spain
facility: Hospital Universitario Río Ortega
city: Zamora
country: Spain
facility: Complejo Hospitalario Zamora
Study officials:
affiliation: Hospital Puerta de Hierro de Majadahonda de Madrid
name: Mariano Provencio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.