Covid-19GRAVIDNCT04344002
LunG and Melanoma canceR pAtients coVId19 Disease (GRAVID)
An observational study of Covid-19 and Lung Cancer, run by Spanish Lung Cancer Group at 75 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid-19, Lung Cancer
- How many people
- 886 participants
- Where
- 75 sitesSpain
- Study dates
- 21 Apr 2020to 6 Oct 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with lung cancer and who have been infected with COVID-19.
Who may be able to join
- Patients diagnosed with lung cancer
- Patients who have contracted COVID-19 infection
Who cannot join
- Patients diagnosed with lung cancer but no confirmation of COVID-19 infection.
Trial locations and contacts
75 sites in 1 country.
75 sites in 1 country
Spain75 sites
Complejo Hospitalario de la Coruña
A Coruña, Coruña, 15006
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
H. Gen. Universitario Alicante
Alicante
Hospital Universitario de La Ribera
Alzira, Valencia
Hospital Ntra. Sra. Sónsoles
Ávila
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital de Cruces
Barakaldo, Vizcaya, 48903
H. Universitario Quirón Dexeus
Barcelona, 08036
Hospital Clínic de Barcelona
Barcelona, 08036
H. Duran i Reynals-ICO
Barcelona, 08907
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital del Mar
Barcelona
H. Clínica Benidorm
Benidorm, Alicante, 03501
Hospital de Basurto
Bilbao, Vizcaya, 48013
Hospital Universitario de Puerto Real
Cadiz
Hospital La Mancha Centro
Ciudad Real
Hospital Virgen de la Luz
Cuenca, 16002
Hospital Instituto Onkologikoa
Donostia / San Sebastian, Basque Country
Hospital de Elche
Elche, Alicante, 03202
Hospital General Universitario de Elda
Elda, Alicante, 03600
Cetir Centre Mèdic
Esplugues de Llobregat, Barcelona
Complejo Hospitalario Universitario de Ferrol
Ferrol, A Coruña
Hospital Universitario de Galdakao
Galdakao, Bizkaia
Hospital Dr. Josep Trueta
Girona, 17007
Hospital Universitario Virgen de las Nieves
Granada
Hospital General de Granollers
Granollers, Barcelona
Hospital de Guadalajara
Guadalajara, 19002
H. Insular de Gran Canarias
Las Palmas de Gran Canaria, Gran Canarias, 35016
Hospital Severo Ochoa
Leganés, Madrid, 28911
Complejo Asistencial Universitario de León
León, 24071
Hospital San Pedro
Logroño, La Rioja
Hospital San Millan Y San Pedro
Logroño
Hospital Universitario Lucus Augusti
Lugo, 27003
MD Anderson
Madrid, 28033
H.U. Puerta de Hierro
Madrid, 28035
Fundación Jimenez Diaz
Madrid, 28040
Hospital Universitario Infanta Sofía
Madrid, 28703
Hospital 12 de Octubre
Madrid
Hospital Clínico San Carlos
Madrid
Hospital de Sanchinarro
Madrid
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario de Fuenlabrada
Madrid
Hospital Universitario del Henares
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital Carlos Haya
Málaga
Hospital de Manacor
Manacor, Mallorca
Hospital de Manises
Manises, Valencia
Hospital Costa del Sol
Marbella, Málaga, 29603
Hospital Universitario de Móstoles
Móstoles, Madrid
Hospital General Universitario Morales Meseguer
Murcia
Hospital Santa María Naí
Ourense
Hospital Son Espases
Palma de Mallorca, 07010
H. Son Llàtzer
Palma de Mallorca, 07198
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008
Complejo Hospitalario de Navarra
Pamplona, Navarre
Hospital Sant Joan de Reus
Reus, Tarragona, 43204
Hospital Clinico de Salamanca
Salamanca, 37007
H. Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital universitario Nuestra Señora Candelaria
Santa Cruz de Tenerife
Hospital General de Segovia
Segovia
Hospital Virgen del Rocío
Seville, 41013
Hospital Sant Pau i Santa Tecla
Tarragona, 43003
Hospital de Torrevieja
Torrevieja, Alicante, 03186
Hospital Verge de la Cinta
Tortosa, Tarragona
H. General U. de Valencia
Valencia, 46014
Hospital Arnau de Vilanova
Valencia
Hospital Clínico Universitario de Valencia
Valencia
Hospital Dr. Peset
Valencia
Hospital Politècnic i Universitari La Fe
Valencia
Hospital Universitario Dr. Peset
Valencia
Instituto Valenciano de Oncología
Valencia
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Hospital Universitario de Áraba
Vitoria-Gasteiz, Áraba, 01009
H. Miguel Servet
Zaragoza, 50009
About this study
Official title: 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.
- Conditions
- Covid-19, Lung Cancer
- Keywords
- covid-19, coronavirus, lung cancer
- Medical subject headings
- COVID-19, Lung Neoplasms, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lung cancer+COVID-19 | lung cancer patients diagnosed with COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical data of lung cancer patients with COVID-19 diagnoses
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.
Measured: From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years
Diagnosis data
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
Measured: From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years
Treatments received
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
Measured: From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years
Prognostic factors
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.
Measured: From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start21 Apr 2020
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 886 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Spanish Lung Cancer Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano MD Provencio, MD, Study chair, Hospital Puerta de Hierro de Majadahonda de MadridCristina MD Avendaño Solá, MD, Study chair, Hospital Puerta de Hierro de Majadahonda de MadridMaría MD González-Cao, MD, Study chair, Hospital Universitario Dexeus de Barcelona.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344002
- Sponsor's protocol ID
- GECP 20/02_GRAVID
- Acronym
- GRAVID
- Status last verified
- Jun 2022
- First submitted
- 9 Apr 2020
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonzalez-Cao M, Puertolas T, Martinez-Vila C, Carrera C, Maldonado Seral C, Rodriguez-Jimenez P, Sequero S, Cerezuela-Fuentes P, Feltes Ochoa R, Munoz E, Antonanzas Basa M, Martin-Liberal J, Soria A, Francisco Rodriguez Moreno J, Marquez-Rodas I, Lopez Criado P, Luis Manzano J, Lopez-Castro R, Ayala de Miguel P, Villalobos L, Martin Algarra S, Gonzalez-Barrallo I, Boada A, Garcia Castano A, Puig S, Crespo G, Luna Fra P, Aguayo Zamora C, Feito Rodriguez M, Valles L, Drozdowskyj A, Gardeazabal J, Antonio Fernandez-Morales L, Rodrigo A, Cruz R, Yelamos O, Rubio B, Mujica K, Provencio M, Berrocal A; Spanish Melanoma Group (GEM). SARS-CoV-2 infection in patients with melanoma: results of the Spanish Melanoma Group registry. Clin Transl Oncol. 2023 Mar;25(3):768-775. doi: 10.1007/s12094-022-02985-7. Epub 2022 Dec 24.
PubMed 36566266
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Register of Spanish Lung and Melanoma Cancer Patients With COVID19 Disease
- ClinicalTrials.gov ID
- NCT04344002
- Acronym / sponsor ID
- GRAVID / GECP 20/02_GRAVID
- Conditions
- Covid-19, Lung Cancer
- Keywords
- covid-19, coronavirus, lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- Spanish Lung Cancer GroupUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer+COVID-19 | – | –lung cancer patients diagnosed with COVID-19 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with lung cancer and who have been infected with COVID-19.
Key inclusion criteria (2 listed)
- Patients diagnosed with lung cancer
- Patients who have contracted COVID-19 infection
Key exclusion criteria (1 listed)
- Patients diagnosed with lung cancer but no confirmation of COVID-19 infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Derived from this study: PubMed 36566266Gonzalez-Cao M, Puertolas T, Martinez-Vila C, Carrera C, Maldonado Seral C, Rodriguez-Jimenez P, Sequero S, Cerezuela-Fuentes P, Feltes Ochoa R, Munoz E, Antonanzas Basa M, Martin-Liberal J, Soria A, Francisco Rodriguez Moreno J, Marquez-Rodas I, Lopez Criado P, Luis Manzano J, Lopez-Castro R, Ayala de Miguel P, Villalobos L, Martin Algarra S, Gonzalez-Barrallo I, Boada A, Garcia Castano A, Puig S, Crespo G, Luna Fra P, Aguayo Zamora C, Feito Rodriguez M, Valles L, Drozdowskyj A, Gardeazabal J, Antonio Fernandez-Morales L, Rodrigo A, Cruz R, Yelamos O, Rubio B, Mujica K, Provencio M, Berrocal A; Spanish Melanoma Group (GEM). SARS-CoV-2 infection in patients with melanoma: results of the Spanish Melanoma Group registry. Clin Transl Oncol. 2023 Mar;25(3):768-775. doi: 10.1007/s12094-022-02985-7. Epub 2022 Dec 24.
- Web page of the sponsor where users can find more information about Fundacion GECP studiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariano MD Provencio, MD study chair
Hospital Puerta de Hierro de Majadahonda de Madrid
Cristina MD Avendaño Solá, MD study chair
Hospital Puerta de Hierro de Majadahonda de Madrid
María MD González-Cao, MD study chair
Hospital Universitario Dexeus de Barcelona.
75 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Lung Cancer, run by Spanish Lung Cancer Group at 75 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.