Lung CancerVAC-CaPNCT05009030
Anti-SARS-COV2 Vaccination Study in Lung Cancer Patients
An observational study of Lung Cancer and Covid19, run by Fundación GECP at 51 sites in Spain.
Trial summary
Observational and multicenter retrospective study of data collection in hospital centers throughout the Spanish geography. This study aims to be nationwide in order to study general common variables of the patients, as well as the correlation with the cancer treatments received. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Covid19
- What is being tested?
- COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 794 participants
- Where
- 51 sitesSpain
- Study dates
- 6 May 2021to 28 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lung cancer of any histology and stage who receive an anti-COVID-19 vaccine approved by the health authorities. Patients would be eligible whether they have suffered from SARS-CoV2 infection or have not had COVID19.
Who may be able to join
- Patients diagnosed with lung cancer of any stage and histology who have or have not contracted COVID-19 and who have been vaccinated with an EMA approved COVID-19 vaccine.
- Age equal to or greater than 18 years
Who cannot join
- Patients who have not received an EMA approved COVID-19 vaccine.
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
Spain51 sites
Hospital Universitario De A Coruna
A Coruña, 15006
Hospital La Mancha Centro
Alcázar de San Juan, Ciudad Real, 13600
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Nuestra Señora De Sonsoles
Ávila, 05004
Hospital Germans Trias I Pujol
Badalona, Barcelona, 08916
Hospital Universitario Cruces
Barakaldo, Vizcaya, 48903
Hospital Universitari Quiron Dexeus
Barcelona, 08028
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital de Basurto
Bilbao, 48013
Hospital General Universitario de Elche
Elche, Alicante, 03203
Hospital Galdakao-Usansolo
Galdakao, Bizkaia, 48960
ICO Girona, Hospital Josep Trueta
Girona, 17007
Hospital Universitario Virgen De Las Nieves
Granada, 18014
Hospital San Cecilio
Granada, 18016
Hospital Universitario de Jaén
Jaén, 23007
Hospital Universitario Jerez De La Frontera
Jerez de la Frontera, Cádiz, 11407
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario Insular de Gran canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911
Hospital Universitario de León
León, 24071
Hospital San Pedro De Logroño
Logroño, La Rioja, 26006
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Clínico San Carlos
Madrid, 28040
Hospital 12 De Octubre
Madrid, 28041
Hospital Universitario HM Sanchinarro
Madrid, 28050
Hospital Fundación de Alcorcón
Madrid, 28922
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital General Universitario de Málaga
Málaga, 29010
Hospital De Mataro
Mataró, Barcelona, 08304
Hospital Universitario De Mostoles
Móstoles, Madrid, 28935
Hospital Universitari Son Llatzer
Palma de Mallorca, 07198
Complejo Hospitalario Pontevedra
Pontevedra, 36071
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital Clínico de Salamanca
Salamanca, 37007
Hospital Universitario Nuestra Señora La Candelaria
Santa Cruz de Tenerife, 38009
Complejo Hospitalario Universitario De Santiago
Santiago de Compostela, A Coruña, 15706
Hospital General De Segovia
Segovia, 40002
Hospital De Valme
Seville, 41014
Hospital De Sant Pau i Sta. Tecla
Tarragona, 43003
Hospital Virgen De La Salud
Toledo, 45071
Hospital De Torrevieja
Torrevieja, Alicante, 03186
Hospital Verge De La Cinta
Tortosa, Tarragona, 43500
Instituto Valenciano De Oncología
Valencia, 46009
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitario Dr. Peset
Valencia, 46017
Hospital Universitario La Fe
Valencia, 46026
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Hospital Universitario Araba-Sede Txagorritxu
Vitoria-Gasteiz, Araba, 01009
Complejo Asistencial De Zamora
Zamora, 49022
Hospital Miguel Servet
Zaragoza, 50009
About this study
Official title: Observational Study on the Effectiveness and Safety of Vaccination Anti-SARS-CoV2 in Patients With Lung Cancer
Observational and multicenter retrospective study of data collection in hospital centers throughout the Spanish geography.
This study aims to be nationwide in order to study general common variables of the patients, as well as the correlation with the cancer treatments received.
Read the detailed description
Observational and multicenter retrospective study of data collection in hospital centers throughout the Spanish geography.
This study aims to be nationwide in order to study general common variables of the patients, as well as the correlation with the cancer treatments received.
Disease and study population Patients with lung cancer of any histology and stage who receive an anti-COVID-19 vaccine approved by the health authorities. Patients would be eligible whether they have suffered from SARS-CoV2 infection or have not had COVID19.
The study will be extended to all the centers of the Spanish Lung Cancer Group, more than 170 centers and 500 professionals, and it is expected that around 500 cases will be collected.
The main objective of the study is to collect the safety and efficacy of the vaccine against SARS-CoV-2 in cancer patients, as well as its potential interactions with antineoplastic therapies.
The data collection will take place throughout the year 2021
- Conditions
- Lung Cancer, Covid19
- Being tested
- COVID-19 vaccine
- Keywords
- COVID-19 vaccine
- Medical subject headings
- Lung Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccineDrug
Lung cancer patients will receive an anti-COVID19 vaccine approved by the European Medicines Agency according to the guidelines approved by the regulatory authorities
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with lung cancer of any histology and stage who receive an anti-COVID-19 vaccine approved by the health authorities. Patients would be eligible whether they have suffered from SARS-CoV2 infection or have not had COVID19. Receives: Drug: COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of the COVID19 vaccine
Analyze patients who do not become infected with COVID-19 after being vaccinated
Measured: From the date of the last dose of the vaccine until three months later
Incidence of COVID-19 vaccine-Emergent Adverse Events (Safety and Tolerability)
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
Measured: From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug
Secondary outcomes (2)
Determine the frequency of COVID-19 and its severity in lung cancer patients receiving the anti-COVID vaccine
Analyze patients who become infected with COVID-19 after being vaccinated
Measured: From the date of the last dose of the vaccine until three months later
Incidence of COVID-19 vaccine-Emergent Adverse Events and toxicities associated with antineoplastic treatments (Safety and Tolerability)
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
Measured: From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start6 May 2021
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Retrospective
- Enrolment
- 794 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación GECP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ernest Nadal, MD, Study chair, Fundación GECP Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009030
- Sponsor's protocol ID
- GECP 21/01_VAC-CaP
- Acronym
- VAC-CaP
- Status last verified
- Jul 2022
- First submitted
- 10 Aug 2021
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Effectiveness and Safety of Vaccination Anti-SARS-CoV2 in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT05009030
- Acronym / sponsor ID
- VAC-CaP / GECP 21/01_VAC-CaP
- Conditions
- Lung Cancer, Covid19
- Keywords
- COVID-19 vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 794 participants (actual)
- Lead sponsor
- Fundación GECPUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 17 Aug 2021 (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.
Observational and multicenter retrospective study of data collection in hospital centers throughout the Spanish geography.
This study aims to be nationwide in order to study general common variables of the patients, as well as the correlation with the cancer treatments received.
Detailed description
Observational and multicenter retrospective study of data collection in hospital centers throughout the Spanish geography.
This study aims to be nationwide in order to study general common variables of the patients, as well as the correlation with the cancer treatments received.
Disease and study population Patients with lung cancer of any histology and stage who receive an anti-COVID-19 vaccine approved by the health authorities. Patients would be eligible whether they have suffered from SARS-CoV2 infection or have not had COVID19.
The study will be extended to all the centers of the Spanish Lung Cancer Group, more than 170 centers and 500 professionals, and it is expected that around 500 cases will be collected.
The main objective of the study is to collect the safety and efficacy of the vaccine against SARS-CoV-2 in cancer patients, as well as its potential interactions with antineoplastic therapies.
The data collection will take place throughout the year 2021
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: COVID-19 vaccinePatients with lung cancer of any histology and stage who receive an anti-COVID-19 vaccine approved by the health authorities. Patients would be eligible whether they have suffered from SARS-CoV2 infection or have not had COVID19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung cancer of any histology and stage who receive an anti-COVID-19 vaccine approved by the health authorities. Patients would be eligible whether they have suffered from SARS-CoV2 infection or have not had COVID19.
Key inclusion criteria (2 listed)
- Patients diagnosed with lung cancer of any stage and histology who have or have not contracted COVID-19 and who have been vaccinated with an EMA approved COVID-19 vaccine.
- Age equal to or greater than 18 years
Key exclusion criteria (1 listed)
- Patients who have not received an EMA approved COVID-19 vaccine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccineLung cancer patients will receive an anti-COVID19 vaccine approved by the European Medicines Agency according to the guidelines approved by the regulatory authorities | Drug | Study group |
Primary outcome
Determine the efficacy of the COVID19 vaccine
Time frame: From the date of the last dose of the vaccine until three months later
Analyze patients who do not become infected with COVID-19 after being vaccinated
Incidence of COVID-19 vaccine-Emergent Adverse Events (Safety and Tolerability)
Time frame: From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
2 secondary outcomes
Determine the frequency of COVID-19 and its severity in lung cancer patients receiving the anti-COVID vaccine
Time frame: From the date of the last dose of the vaccine until three months later
Incidence of COVID-19 vaccine-Emergent Adverse Events and toxicities associated with antineoplastic treatments (Safety and Tolerability)
Time frame: From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug
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 29 Jul 2022.
- Web page of the sponsor where users can find more information about Fundación GECP studiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ernest Nadal, MD study chair
Fundación GECP Investigator
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Covid19, run by Fundación GECP at 51 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 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 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?
Determine the efficacy of the COVID19 vaccine (time frame: From the date of the last dose of the vaccine until three months later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2022.