Anti-SARS-COV2 Vaccination Study in Lung Cancer Patients

NCT ID: NCT05009030

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

794 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-06

Study Completion Date

2022-03-28

Brief Summary

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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

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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

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Lung Cancer Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

COVID-19 vaccine

Intervention Type DRUG

Lung cancer patients will receive an anti-COVID19 vaccine approved by the European Medicines Agency according to the guidelines approved by the regulatory authorities

Interventions

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COVID-19 vaccine

Lung cancer patients will receive an anti-COVID19 vaccine approved by the European Medicines Agency according to the guidelines approved by the regulatory authorities

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación GECP

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ernest Nadal, MD

Role: STUDY_CHAIR

Fundación GECP Investigator

Locations

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Complejo Hospitalario Universitario De Santiago

Santiago de Compostela, A Coruña, Spain

Site Status

Hospital General Universitario de Elche

Elche, Alicante, Spain

Site Status

Hospital De Torrevieja

Torrevieja, Alicante, Spain

Site Status

Hospital Universitario Araba-Sede Txagorritxu

Vitoria-Gasteiz, Araba, Spain

Site Status

Hospital Germans Trias I Pujol

Badalona, Barcelona, Spain

Site Status

ICO Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital De Mataro

Mataró, Barcelona, Spain

Site Status

Hospital Galdakao-Usansolo

Galdakao, Bizkaia, Spain

Site Status

Hospital La Mancha Centro

Alcázar de San Juan, Ciudad Real, Spain

Site Status

Hospital Universitario Jerez De La Frontera

Jerez de la Frontera, Cádiz, Spain

Site Status

Hospital Universitario Insular de Gran canaria

Las Palmas de Gran Canaria, Gran Canaria, Spain

Site Status

Hospital San Pedro De Logroño

Logroño, La Rioja, Spain

Site Status

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Site Status

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status

Hospital Universitario De Mostoles

Móstoles, Madrid, Spain

Site Status

Hospital Universitario Quiron Madrid

Pozuelo de Alarcón, Madrid, Spain

Site Status

Hospital Verge De La Cinta

Tortosa, Tarragona, Spain

Site Status

Hospital Universitario Cruces

Barakaldo, Vizcaya, Spain

Site Status

Hospital Universitario De A Coruna

A Coruña, , Spain

Site Status

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status

Hospital Nuestra Señora De Sonsoles

Ávila, , Spain

Site Status

Hospital Universitari Quiron Dexeus

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital de Basurto

Bilbao, , Spain

Site Status

ICO Girona, Hospital Josep Trueta

Girona, , Spain

Site Status

Hospital Universitario Virgen De Las Nieves

Granada, , Spain

Site Status

Hospital San Cecilio

Granada, , Spain

Site Status

Hospital Universitario de Jaén

Jaén, , Spain

Site Status

Hospital Universitario de León

León, , Spain

Site Status

Hospital Universitario Lucus Augusti

Lugo, , Spain

Site Status

Hospital Universitario Infanta Leonor

Madrid, , Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Hospital 12 De Octubre

Madrid, , Spain

Site Status

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Site Status

Hospital Fundación de Alcorcón

Madrid, , Spain

Site Status

Hospital General Universitario de Málaga

Málaga, , Spain

Site Status

Hospital Universitari Son Llatzer

Palma de Mallorca, , Spain

Site Status

Complejo Hospitalario Pontevedra

Pontevedra, , Spain

Site Status

Hospital Clínico de Salamanca

Salamanca, , Spain

Site Status

Hospital Universitario Nuestra Señora La Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

Hospital General De Segovia

Segovia, , Spain

Site Status

Hospital De Valme

Seville, , Spain

Site Status

Hospital De Sant Pau i Sta. Tecla

Tarragona, , Spain

Site Status

Hospital Virgen De La Salud

Toledo, , Spain

Site Status

Instituto Valenciano De Oncología

Valencia, , Spain

Site Status

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Universitario Dr. Peset

Valencia, , Spain

Site Status

Hospital Universitario La Fe

Valencia, , Spain

Site Status

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

Complejo Asistencial De Zamora

Zamora, , Spain

Site Status

Hospital Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Spain

Related Links

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http://www.gecp.org

Web page of the sponsor where users can find more information about Fundación GECP studies

Other Identifiers

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GECP 21/01_VAC-CaP

Identifier Type: -

Identifier Source: org_study_id

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