Anti-SARS-COV2 Vaccination Study in Lung Cancer Patients

NCT05009030 | Completed

• 1 other identifier: GECP 21/01_VAC-CaP
• Study Type: observational
• Target: 794
• Locations: 1 country
• Sites: 51

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.

Conditions

Lung Cancer; Covid19

Keywords

COVID-19 vaccine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Determine the frequency of COVID-19 and its severity in lung cancer patients receiving the anti-COVID vaccine

  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)

  From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug

Study Arms (1)

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.

Drug: COVID-19 vaccine

Interventions

COVID-19 vaccine 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

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación GECP: lead

Study Sites (51)

Complejo Hospitalario Universitario De Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital De Torrevieja

Torrevieja, Alicante, 03186, Spain

Location

Hospital Universitario Araba-Sede Txagorritxu

Vitoria-Gasteiz, Araba, 01009, Spain

Location

Hospital Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

Location

ICO Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital De Mataro

Mataró, Barcelona, 08304, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, Bizkaia, 48960, Spain

Location

Hospital La Mancha Centro

Alcázar de San Juan, Ciudad Real, 13600, Spain

Location

Hospital Universitario Jerez De La Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital Universitario Insular de Gran canaria

Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain

Location

Hospital San Pedro De Logroño

Logroño, La Rioja, 26006, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario De Mostoles

Móstoles, Madrid, 28935, Spain

Location

Hospital Universitario Quiron Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Verge De La Cinta

Tortosa, Tarragona, 43500, Spain

Location

Hospital Universitario Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Universitario De A Coruna

A Coruña, 15006, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Nuestra Señora De Sonsoles

Ávila, 05004, Spain

Location

Hospital Universitari Quiron Dexeus

Barcelona, 08028, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital de Basurto

Bilbao, 48013, Spain

Location

ICO Girona, Hospital Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario Virgen De Las Nieves

Granada, 18014, Spain

Location

Hospital San Cecilio

Granada, 18016, Spain

Location

Hospital Universitario de Jaén

Jaén, 23007, Spain

Location

Hospital Universitario de León

León, 24071, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital 12 De Octubre

Madrid, 28041, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Hospital Fundación de Alcorcón

Madrid, 28922, Spain

Location

Hospital General Universitario de Málaga

Málaga, 29010, Spain

Location

Hospital Universitari Son Llatzer

Palma de Mallorca, 07198, Spain

Location

Complejo Hospitalario Pontevedra

Pontevedra, 36071, Spain

Location

Hospital Clínico de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Nuestra Señora La Candelaria

Santa Cruz de Tenerife, 38009, Spain

Location

Hospital General De Segovia

Segovia, 40002, Spain

Location

Hospital De Valme

Seville, 41014, Spain

Location

Hospital De Sant Pau i Sta. Tecla

Tarragona, 43003, Spain

Location

Hospital Virgen De La Salud

Toledo, 45071, Spain

Location

Instituto Valenciano De Oncología

Valencia, 46009, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

Location

Hospital Universitario La Fe

Valencia, 46026, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Complejo Asistencial De Zamora

Zamora, 49022, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

Related Links

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

MeSH Terms

Conditions

Lung Neoplasms; COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ernest Nadal, MD

  Fundación GECP Investigator

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 17, 2021
• Study Start: May 6, 2021
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (51)