Lung CancerSOLIDNCT04407143
Study of the Immunity of Patients With Lung Cancer and COVID-19 Infection
An observational study of Lung Cancer and COVID, run by Fundación GECP at 68 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, COVID, Corona Virus Infection
- What is being tested?
- IgG test
- How many people
- 1,980 participants
- Where
- 68 sitesSpain
- Study dates
- 15 Apr 2020to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have not signed or do not wish to sign the informed consent for this study
Who may be able to join
- Patients diagnosed with lung cancer at any stage of the disease
- Age ≥ 18
- Patients who have signed the informed consent for this study
Who cannot join
- 1. Patients who have not signed or do not wish to sign the informed consent for this study
Trial locations and contacts
68 sites in 1 country.
68 sites in 1 country
Spain68 sites
Complejo Hospitalario de A Coruña
A Coruña, A Coruña, 15006
Hospital La Esperanza
A Coruña
Hospital Universitario de Ferrol
A Coruña
Hospital Virgen de los Lirios
Alicante
Hospital Germans Trias i Pujol
Badalona
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari Dexeus
Barcelona
Hospital Universitario Cruces
Bilbao
Hospital Universitario de Burgos
Burgos, Burgos
Hospital Universitario San Pedro de Alcántara
Cáceres
Hospital Universitario Puerta del Mar
Cadiz
Hospital Universitario Puerto Real
Cadiz
Hospital General La Mancha Centro
Ciudad Real
Hospital Universitario Reina Sofía
Córdoba, Córdoba, 14004
Hospital General Universitario de Elche
Elche, Alicante, 03203
Hospital Universitario de Vinalopó
Elche
Hospital Dr. Josep Trueta
Girona, Girona, 17007
Hospital Universitario de Guadalajara
Guadalajara
Complejo Hospitalario de Jaén
Jaén, Jaén, 23007
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario Insular de Gran canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016
Complejo Asistencial Universitario de León
León
Hospital universitari Arnau de Vilanova
Lleida
Hospital San Pedro
Logroño
Hospital Universitario Lucus Augusti
Lugo
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario La Paz
Madrid, Madrid, 28046
Hospital Puerta de Hierro
Madrid, Madrid, 28222
Clínica Universidad de Navarra
Madrid, Madrid
Hospital de Sanchinarro
Madrid, Madrid
Hospital Severo Ochoa
Madrid, Madrid
Hospital Universitario Infanta Cristina
Madrid, Madrid
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario de Móstoles
Madrid
Hospital Universitario del Henares
Madrid
Hospital Universitario Fundación Alcorcón
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital Universitario Infanta Sofía
Madrid
Hospital Universitario Príncipe de Asturias
Madrid
Hospital General Universitario de Málaga
Málaga, Málaga, 29010
Hospital Costa del Sol
Málaga
Complejo Hospitalario Universitario de Ourense Santa María Nai
Ourense
Hospital Universitario Son Llàtzer
Palma de Mallorca, Mallorca, 07198
Hospital Universitario Son Espases
Palma de Mallorca
Clínica Universidad de Navarra
Pamplona
Complejo Hospitalario de Navarra
Pamplona
Hospital Universitario Sant Joan de Reus
Reus
Hospital Universitario de Salamanca
Salamanca
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Tenerife
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Hospital General de Segovia
Segovia
Hospital Virgen del Rocío
Seville, Sevilla, 41013
Hospital Sant Pau i Santa Tecla
Tarragona
Hospital Universitario de Torrejón
Torrejón, Madrid
Hospital Universitari i Politécnic La Fe
Valencia, Valencia, 46009
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010
Hospital General de Valencia
Valencia, Valencia, 46014
Hospital Universitario Dr. Peset
Valencia, Valencia
Hospital Arnau de Vilanova
Valencia
Hospital de Manises
Valencia
Hospital General Universitario de Valencia
Valencia
Hospital Lluís Alcanyís
Valencia
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003
Hospital Universitario Río Ortega
Valladolid
Complexo Hospitalario Universitario de Vigo
Vigo, Pontevedra, 36036
Complejo Hospitalario Zamora
Zamora
About this study
Official title: Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection
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.
Read the 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.
- Conditions
- Lung Cancer, COVID, Corona Virus Infection
- Being tested
- IgG test
- Keywords
- IgG, coronavirus, COVID-19, lung cancer
- Medical subject headings
- Lung Neoplasms, Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgG testDiagnostic test
IgG+ blood test by ELISA method.
| Study group | Role | What they receive |
|---|---|---|
| lung cancer+COVID-19 | Lung cancer patients infected by COVID-19 Receives: Diagnostic Test: IgG test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the characteristics of patients
Description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection.
Measured: From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeks
Secondary outcomes (1)
Detection of antibodies (IgG) at 6 months after SARS-COV2 vaccines
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.
Measured: From the date of complete SARS-COV2 vaccination administration until 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start15 Apr 2020
- Primary completion30 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación GECP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano Provencio, MD, Principal investigator, Hospital Puerta de Hierro de Majadahonda de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407143
- Sponsor's protocol ID
- GECP 20/04_SOLID
- Acronym
- SOLID
- Status last verified
- Jun 2022
- First submitted
- 25 May 2020
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37639820Provencio 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.
PubMed 35242627
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04407143
- Acronym / sponsor ID
- SOLID / GECP 20/04_SOLID
- Conditions
- Lung Cancer, COVID, Corona Virus Infection
- Keywords
- IgG, coronavirus, COVID-19, lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,980 participants (actual)
- Lead sponsor
- Fundación GECPUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer+COVID-19 | – | Diagnostic Test: IgG testLung cancer patients infected by COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have not signed or do not wish to sign the informed consent for this study
Key inclusion criteria (3 listed)
- Patients diagnosed with lung cancer at any stage of the disease
- Age ≥ 18
- Patients who have signed the informed consent for this study
Key exclusion criteria (1 listed)
- 1. Patients who have not signed or do not wish to sign the informed consent for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IgG testIgG+ blood test by ELISA method. | Diagnostic test | lung cancer+COVID-19 |
Primary outcome
Description of the characteristics of patients
Time frame: 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.
1 secondary outcome
Detection of antibodies (IgG) at 6 months after SARS-COV2 vaccines
Time frame: From the date of complete SARS-COV2 vaccination administration until 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Derived from this study: PubMed 37639820Provencio 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.
- Derived from this study: PubMed 35242627Provencio 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.
- Web page of the sponsor where users can find more information about Fundación GECP studiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariano Provencio, MD principal investigator
Hospital Puerta de Hierro de Majadahonda de Madrid
68 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and COVID, run by Fundación GECP at 68 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the characteristics of patients (time frame: From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04407143, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.