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LunG and Melanoma canceR pAtients coVId19 Disease (GRAVID) (GRAVID)

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: NCT04344002
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Spanish Lung Cancer Group

Study Description
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Brief Summary:

This is a multi-centre study on lung cancer patients which experienced COVID-19. Information on clinical features, clinical course, management and outcomes will be collected for both, thoracic cancers and COVID-19 infection. Firstly, investigators will be registered in an online secure registry. After that, a protocol will be developed in order to collect clinical data for the research. It will also include I on the care organization or the perception of the patient and their family members.

The final stage will consist on retrospective data collection from patients. So, it is a retrospective study data collection, preceded by prospective data registry.


Condition or disease
Covid-19 Lung Cancer

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Month
Official Title: Observational Retrospective Register of Spanish Lung and Melanoma Cancer Patients With COVID19 Disease
Actual Study Start Date : April 21, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Groups and Cohorts
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Group/Cohort
lung cancer+COVID-19
lung cancer patients diagnosed with COVID-19


Outcome Measures
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Primary Outcome Measures :
  1. Clinical data of lung cancer patients with COVID-19 diagnoses [ Time Frame: From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years ]
    Describe characteristics and evolution of Spanish patients preferably with lung cancer who contract COVID 19 infection with identification and study of factors of interest, as well as clinical data.

  2. Diagnosis data [ Time Frame: From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years ]
    Describe characteristics and evolution of Spanish patients preferably with lung cancer who contract COVID 19 infection with identification and study of factors of interest, as well as data about diagnosis

  3. Treatments received [ Time Frame: From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years ]
    Describe characteristics and evolution of Spanish patients preferably with lung cancer who contract COVID 19 infection with identification and study of factors of interest, as well as treatments received

  4. Prognostic factors [ Time Frame: From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years ]
    Describe characteristics and evolution of Spanish patients preferably with lung cancer who contract COVID 19 infection with identification and study of factors of interest, as well as prognostic factors.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with lung cancer and who have been infected with COVID-19.
Criteria

Inclusion Criteria:

  • Patients diagnosed with lung cancer
  • Patients who have contracted COVID-19 infection

Exclusion Criteria:

  • Patients diagnosed with lung cancer but no confirmation of COVID-19 infection.
Contacts and Locations
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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): NCT04344002


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

Locations
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Sponsors and Collaborators
Spanish Lung Cancer Group
Investigators
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Study Chair: Mariano MD Provencio, MD Hospital Puerta de Hierro de Majadahonda de Madrid
Study Chair: Cristina MD Avendaño Solá, MD Hospital Puerta de Hierro de Majadahonda de Madrid
Study Chair: María MD González-Cao, MD Hospital Universitario Dexeus de Barcelona.
More Information
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Responsible Party: Spanish Lung Cancer Group
ClinicalTrials.gov Identifier: NCT04344002    
Other Study ID Numbers: GECP 20/02_GRAVID
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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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 Spanish Lung Cancer Group:
covid-19
coronavirus
lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Melanoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas