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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407143
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Fundación GECP

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.


Condition or disease Intervention/treatment
Lung Cancer COVID Corona Virus Infection Diagnostic Test: IgG test

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Study Type : Observational
Estimated Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407143


Contacts
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Contact: Eva Pereira +34934302006 epereira@gecp.org

Locations
Show Show 68 study locations
Sponsors and Collaborators
Fundación GECP
Investigators
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Principal Investigator: Mariano Provencio, MD Hospital Puerta de Hierro de Majadahonda de Madrid
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Responsible Party: Fundación GECP
ClinicalTrials.gov Identifier: NCT04407143    
Other Study ID Numbers: GECP 20/04_SOLID
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación GECP:
IgG
coronavirus
COVID-19
lung cancer
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections