Ignite Creation Date:
2024-05-06 @ 2:43 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04407143
Status:
COMPLETED
Last Update Posted:
2022-06-03
First Post:
2020-05-25
Brief Title:
Study of the Immunity of Patients With Lung Cancer and COVID-19 Infection
Sponsor:
Fundación GECP
Organization:
Fundación GECP
Study Overview
Official Title:
Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOLID
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
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 1500 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
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 1500 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None