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

F

Fundación GECP

Status

Completed

Conditions

Corona Virus Infection
COVID
Lung Cancer

Treatments

Diagnostic Test: IgG test

Study type

Observational

Funder types

Other

Identifiers

NCT04407143
GECP 20/04_SOLID

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,980 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,980 participants in 1 patient group

lung cancer+COVID-19
Description:
Lung cancer patients infected by COVID-19
Treatment:
Diagnostic Test: IgG test

Trial contacts and locations

68

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Data sourced from clinicaltrials.gov

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