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

June 1, 2022 updated by: Fundación GECP

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1980

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario de A Coruña
      • A Coruña, Spain
        • Hospital La Esperanza
      • A Coruña, Spain
        • Hospital Universitario de Ferrol
      • Alicante, Spain
        • Hospital Virgen de los Lirios
      • Badalona, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Universitari Dexeus
      • Bilbao, Spain
        • Hospital Universitario Cruces
      • Burgos, Spain
        • Hospital Universitario de Burgos
      • Cadiz, Spain
        • Hospital Universitario Puerto Real
      • Ciudad Real, Spain
        • Hospital General La Mancha Centro
      • Cáceres, Spain
        • Hospital Universitario San Pedro de Alcantara
      • Cádiz, Spain
        • Hospital Universitario Puerta Del Mar
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Elche, Spain
        • Hospital Universitario de Vinalopó
      • Girona, Spain, 17007
        • Hospital Dr. Josep Trueta
      • Guadalajara, Spain
        • Hospital Universitario de Guadalajara
      • Jaén, Spain, 23007
        • Complejo Hospitalario de Jaen
      • León, Spain
        • Complejo Asistencial Universitario de León
      • Lleida, Spain
        • Hospital Universitari Arnau de Vilanova
      • Logroño, Spain
        • Hospital San Pedro
      • Lugo, Spain
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Clinica Universidad de Navarra
      • Madrid, Spain
        • Hospital Universitario de Móstoles
      • Madrid, Spain
        • Hospital Universitario Infanta Leonor
      • Madrid, Spain
        • Hospital Severo Ochoa
      • Madrid, Spain, 28222
        • Hospital Puerta de Hierro
      • Madrid, Spain
        • Hospital Universitario Infanta Sofía
      • Madrid, Spain
        • Hospital Universitario Fundacion Alcorcon
      • Madrid, Spain
        • Hospital Universitario Principe de Asturias
      • Madrid, Spain
        • Hospital de Sanchinarro
      • Madrid, Spain
        • Hospital Universitario Infanta Cristina
      • Madrid, Spain
        • Hospital Universitario del Henares
      • Málaga, Spain
        • Hospital Costa del Sol
      • Málaga, Spain, 29010
        • Hospital General Universitario de Málaga
      • Ourense, Spain
        • Complejo Hospitalario Universitario de Ourense Santa María Nai
      • Palma De Mallorca, Spain
        • Hospital Universitario Son Espases
      • Pamplona, Spain
        • Clinica Universidad de Navarra
      • Pamplona, Spain
        • Complejo Hospitalario de Navarra
      • Reus, Spain
        • Hospital Universitario Sant Joan de Reus
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
      • Santa Cruz De Tenerife, Spain
        • Hospital Universitario de Canarias
      • Segovia, Spain
        • Hospital General de Segovia
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Tarragona, Spain
        • Hospital Sant Pau i Santa Tecla
      • Tenerife, Spain
        • Hospital Universitario Nuestra Señora de Candelaria
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain
        • Hospital Arnau de Vilanova
      • Valencia, Spain, 46014
        • Hospital General de Valencia
      • Valencia, Spain
        • Hospital Universitario Dr. Peset
      • Valencia, Spain
        • Hospital General Universitario de Valencia
      • Valencia, Spain
        • Hospital de Manises
      • Valencia, Spain, 46009
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain
        • Hospital Lluis Alcanyis
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid
      • Valladolid, Spain
        • Hospital Universitario Rio Ortega
      • Zamora, Spain
        • Complejo Hospitalario Zamora
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08908
        • ICO Hospitalet
    • Gran Canaria
      • Las Palmas De Gran Canaria, Gran Canaria, Spain, 35016
        • Hospital Universitario Insular de Gran Canaria
    • Madrid
      • Torrejón, Madrid, Spain
        • Hospital Universitario de Torrejón
    • Mallorca
      • Palma De Mallorca, Mallorca, Spain, 07198
        • Hospital Universitario Son Llatzer
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36036
        • Complexo Hospitalario Universitario de Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have not signed or do not wish to sign the informed consent for this study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
lung cancer+COVID-19
Lung cancer patients infected by COVID-19
Diagnostic test: IgG test
IgG+ blood test by ELISA method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
From the date of complete SARS-COV2 vaccination administration until 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación GECP

Investigators

  • Principal Investigator: Mariano Provencio, MD, Hospital Puerta de Hierro de Majadahonda de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2020

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECP 20/04_SOLID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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