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NCT05009030 Clinical Trial

Anti-SARS-COV2 Vaccination Study in Lung Cancer Patients

Lung Cancer Clinical Trial

— VAC-CaP  

Official title:
Observational Study on the Effectiveness and Safety of Vaccination Anti-SARS-CoV2 in Patients With Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05009030
Other study ID # GECP 21/01_VAC-CaP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 6, 2021
Est. completion date March 28, 2022

Study information
Verified date July 2022
Source Fundación GECP
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 794
Est. completion date March 28, 2022
Est. primary completion date March 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
Spain Hospital Universitario De A Coruna A Coruña
Spain Hospital La Mancha Centro Alcázar De San Juan Ciudad Real
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital Nuestra Señora De Sonsoles Ávila
Spain Hospital Germans Trias I Pujol Badalona Barcelona
Spain Hospital Universitario Cruces Barakaldo Vizcaya
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital Universitari Quiron Dexeus Barcelona
Spain Hospital de Basurto Bilbao
Spain Hospital General Universitario de Elche Elche Alicante
Spain Hospital Galdakao-Usansolo Galdakao Bizkaia
Spain Hospital Universitario Araba-Sede Txagorritxu Gasteiz / Vitoria Araba
Spain ICO Girona, Hospital Josep Trueta Girona
Spain Hospital San Cecilio Granada
Spain Hospital Universitario Virgen De Las Nieves Granada
Spain ICO Hospitalet Hospitalet de Llobregat Barcelona
Spain Hospital Universitario de Jaén Jaén
Spain Hospital Universitario Jerez De La Frontera Jerez De La Frontera Cádiz
Spain Hospital Universitario Insular de Gran canaria Las Palmas De Gran Canaria Gran Canaria
Spain Hospital Universitario Severo Ochoa Leganés Madrid
Spain Hospital Universitario de León León
Spain Hospital San Pedro De Logroño Logroño La Rioja
Spain Hospital Universitario Lucus Augusti Lugo
Spain Hospital 12 De Octubre Madrid
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Fundación de Alcorcón Madrid
Spain Hospital Universitario HM Sanchinarro Madrid
Spain Hospital Universitario Infanta Leonor Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Madrid
Spain Hospital General Universitario de Málaga Málaga
Spain Hospital De Mataro Mataró Barcelona
Spain Hospital Universitario De Mostoles Móstoles Madrid
Spain Hospital Universitari Son Llatzer Palma De Mallorca
Spain Complejo Hospitalario Pontevedra Pontevedra
Spain Hospital Universitario Quiron Madrid Pozuelo De Alarcón Madrid
Spain Hospital Clínico de Salamanca Salamanca
Spain Hospital Universitario Nuestra Señora La Candelaria Santa Cruz De Tenerife
Spain Complejo Hospitalario Universitario De Santiago Santiago De Compostela A Coruña
Spain Hospital General De Segovia Segovia
Spain Hospital De Valme Sevilla
Spain Hospital De Sant Pau i Sta. Tecla Tarragona
Spain Hospital Virgen De La Salud Toledo
Spain Hospital De Torrevieja Torrevieja Alicante
Spain Hospital Verge De La Cinta Tortosa Tarragona
Spain Hospital General Universitario de Valencia Valencia
Spain Hospital Universitario Dr. Peset Valencia
Spain Hospital Universitario La Fe Valencia
Spain Instituto Valenciano De Oncología Valencia
Spain Hospital Clínico Universitario de Valladolid Valladolid
Spain Complejo Asistencial De Zamora Zamora
Spain Hospital Miguel Servet Zaragoza

Sponsors (1)
Lead Sponsor Collaborator
Fundación GECP

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine the efficacy of the COVID19 vaccine Analyze patients who do not become infected with COVID-19 after being vaccinated From the date of the last dose of the vaccine until three months later
Primary 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. From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug
Secondary 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 From the date of the last dose of the vaccine until three months later
Secondary 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. From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug
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