Clinical trial NCT05009030: Anti-SARS-COV2 Vaccination Study in Lung Cancer Patients
Official title: Observational Study on the Effectiveness and Safety of Vaccination Anti-SARS-CoV2 in Patients With Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Covid19
Keywords: COVID-19 vaccine
Lead sponsor: Fundación GECP
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 794
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients who have not received an EMA approved COVID-19 vaccine.

Primary outcomes:
measure: Determine the efficacy of the COVID19 vaccine
timeFrame: From the date of the last dose of the vaccine until three months later
measure: Incidence of COVID-19 vaccine-Emergent Adverse Events (Safety and Tolerability)
timeFrame: From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug
Secondary outcomes:
measure: Determine the frequency of COVID-19 and its severity in lung cancer patients receiving the anti-COVID vaccine
timeFrame: From the date of the last dose of the vaccine until three months later
measure: Incidence of COVID-19 vaccine-Emergent Adverse Events and toxicities associated with antineoplastic treatments (Safety and Tolerability)
timeFrame: From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario De Santiago
state: A Coruña
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Torrevieja
country: Spain
facility: Hospital De Torrevieja
state: Alicante
city: Gasteiz / Vitoria
country: Spain
facility: Hospital Universitario Araba-Sede Txagorritxu
state: Araba
city: Badalona
country: Spain
facility: Hospital Germans Trias I Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: ICO Hospitalet
state: Barcelona
city: Mataró
country: Spain
facility: Hospital De Mataro
state: Barcelona
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
state: Bizkaia
city: Alcázar De San Juan
country: Spain
facility: Hospital La Mancha Centro
state: Ciudad Real
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario Jerez De La Frontera
state: Cádiz
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran canaria
state: Gran Canaria
city: Logroño
country: Spain
facility: Hospital San Pedro De Logroño
state: La Rioja
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario De Mostoles
state: Madrid
city: Pozuelo De Alarcón
country: Spain
facility: Hospital Universitario Quiron Madrid
state: Madrid
city: Tortosa
country: Spain
facility: Hospital Verge De La Cinta
state: Tarragona
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
state: Vizcaya
city: A Coruña
country: Spain
facility: Hospital Universitario De A Coruna
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari Quiron Dexeus
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Girona
country: Spain
facility: ICO Girona, Hospital Josep Trueta
city: Granada
country: Spain
facility: Hospital Universitario Virgen De Las Nieves
city: Granada
country: Spain
facility: Hospital San Cecilio
city: Jaén
country: Spain
facility: Hospital Universitario de Jaén
city: León
country: Spain
facility: Hospital Universitario de León
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 De Octubre
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital Fundación de Alcorcón
city: Málaga
country: Spain
facility: Hospital General Universitario de Málaga
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Llatzer
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Pontevedra
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora La Candelaria
city: Segovia
country: Spain
facility: Hospital General De Segovia
city: Sevilla
country: Spain
facility: Hospital De Valme
city: Tarragona
country: Spain
facility: Hospital De Sant Pau i Sta. Tecla
city: Toledo
country: Spain
facility: Hospital Virgen De La Salud
city: Valencia
country: Spain
facility: Instituto Valenciano De Oncología
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zamora
country: Spain
facility: Complejo Asistencial De Zamora
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Ávila
country: Spain
facility: Hospital Nuestra Señora De Sonsoles
Study officials:
affiliation: Fundación GECP Investigator
name: Ernest Nadal, MD
role: STUDY_CHAIR
References: