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

June 21, 2022 updated by: Spanish Lung Cancer Group

Observational Retrospective Register of Spanish Lung and Melanoma Cancer Patients With COVID19 Disease

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

886

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

      • Alicante, Spain
        • H. Gen. Universitario Alicante
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08036
        • H. Universitario Quirón Dexeus
      • Barcelona, Spain, 08907
        • H. Duran i Reynals-ICO
      • Ciudad Real, Spain
        • Hospital La Mancha Centro
      • Cuenca, Spain, 16002
        • Hospital Virgen de La Luz
      • Cádiz, Spain
        • Hospital Universitario de Puerto Real
      • Girona, Spain, 17007
        • Hospital Dr. Josep Trueta
      • Granada, Spain
        • Hospital Universitario Virgen de Las Nieves
      • Guadalajara, Spain, 19002
        • Hospital de Guadalajara
      • León, Spain, 24071
        • Complejo Asistencial Universitario de Leon
      • Logroño, Spain
        • Hospital San Millan Y San Pedro
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28040
        • Fundación Jiménez Díaz
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain, 28035
        • H.U. Puerta de Hierro
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28033
        • MD Anderson
      • Madrid, Spain
        • Hospital Universitario Infanta Leonor
      • Madrid, Spain
        • Hospital Universitario de Fuenlabrada
      • Madrid, Spain, 28703
        • Hospital Universitario Infanta Sofia
      • Madrid, Spain
        • Hospital de Sanchinarro
      • Madrid, Spain
        • Hospital Universitario del Henares
      • Murcia, Spain
        • Hospital General Universitario Morales Meseguer
      • Málaga, Spain
        • Hospital Carlos Haya
      • Ourense, Spain
        • Hospital Santa Maria Nai
      • Palma de Mallorca, Spain, 07010
        • Hospital Son Espases
      • Palma de Mallorca, Spain, 07198
        • H. Son Llátzer
      • Salamanca, Spain, 37007
        • Hospital Clínico de Salamanca
      • Segovia, Spain
        • Hospital General de Segovia
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Tarragona, Spain, 43003
        • Hospital Sant Pau i Santa Tecla
      • Tenerife, Spain
        • Hospital Universitario Nuestra Señora Candelaria
      • Valencia, Spain
        • Hospital Arnau de Vilanova
      • Valencia, Spain
        • Instituto Valenciano de Oncología
      • Valencia, Spain
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain
        • Hospital Universitario Dr. Peset
      • Valencia, Spain
        • Hospital Dr. Peset
      • Valencia, Spain, 46014
        • H. General U. de Valencia
      • Valencia, Spain
        • Hospital Politècnic i Universitari La Fe
      • Valladolid, Spain, 47003
        • Hospital Clinico Universitario de Valladolid
      • Zaragoza, Spain, 50009
        • H. Miguel Servet
      • Ávila, Spain
        • Hospital Ntra. Sra. Sonsoles
    • A Coruña
      • Ferrol, A Coruña, Spain
        • Complejo Hospitalario Universitario de Ferrol
    • Alicante
      • Benidorm, Alicante, Spain, 03501
        • H. Clínica Benidorm
      • Elche, Alicante, Spain, 03202
        • Hospital de Elche
      • Elda, Alicante, Spain, 03600
        • Hospital General Universitario de Elda
      • Torrevieja, Alicante, Spain, 03186
        • Hospital de Torrevieja
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Esplugues De Llobregat, Barcelona, Spain
        • Cetir Centre Mèdic
      • Granollers, Barcelona, Spain
        • Hospital General de Granollers
    • Bizkaia
      • Galdakao, Bizkaia, Spain
        • Hospital Universitario de Galdakao
    • Coruña
      • La Coruña, Coruña, Spain, 15006
        • Complejo hospitalario de la coruña
    • Gran Canarias
      • Las Palmas De Gran Canaria, Gran Canarias, Spain, 35016
        • H. Insular de Gran Canarias
    • La Rioja
      • Logroño, La Rioja, Spain
        • Hospital San Pedro
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Leganés, Madrid, Spain, 28911
        • Hospital Severo Ochoa
      • Móstoles, Madrid, Spain
        • Hospital Universitario de Móstoles
    • Mallorca
      • Manacor, Mallorca, Spain
        • Hospital de Manacor
    • Málaga
      • Marbella, Málaga, Spain, 29603
        • Hospital Costa del Sol
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra
      • Pamplona, Navarra, Spain
        • Complejo Hospitalario de Navarra
    • País Vasco
      • San Sebastián, País Vasco, Spain
        • Hospital Instituto Onkologikoa
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Hospital Sant Joan de Reus
      • Tortosa, Tarragona, Spain
        • Hospital Verge de la Cinta
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
        • H. Universitario de Canarias
    • Valencia
      • Alzira, Valencia, Spain
        • Hospital Universitario de La Ribera
      • Manises, Valencia, Spain
        • Hospital de Manises
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Hospital De Cruces
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto
    • Áraba
      • Vitoria, Áraba, Spain, 01009
        • Hospital Universitario de Araba

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with lung cancer and who have been infected with COVID-19.

Description

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.

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: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years
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
From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years
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
From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years
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.
From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years

Collaborators and Investigators

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

Investigators

  • 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.

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.

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 21, 2020

Primary Completion (Actual)

October 6, 2021

Study Completion (Actual)

October 6, 2021

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

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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