Anti-SARS-COV2 Vaccination Study in Lung Cancer Patients (VAC-CaP)

July 28, 2022 updated by: Fundación GECP

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

794

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario de A Coruña
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08028
        • Hospital Universitari Quiron Dexeus
      • Bilbao, Spain, 48013
        • Hospital de Basurto
      • Girona, Spain, 17007
        • ICO Girona, Hospital Josep Trueta
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Granada, Spain, 18016
        • Hospital San Cecilio
      • Jaén, Spain, 23007
        • Hospital Universitario de Jaén
      • León, Spain, 24071
        • Hospital Universitario de León
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
      • Madrid, Spain, 28922
        • Hospital Fundación de Alcorcón
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro
      • Málaga, Spain, 29010
        • Hospital General Universitario de Málaga
      • Palma De Mallorca, Spain, 07198
        • Hospital Universitari Son Llatzer
      • Pontevedra, Spain, 36071
        • Complejo Hospitalario Pontevedra
      • Salamanca, Spain, 37007
        • Hospital Clínico de Salamanca
      • Santa Cruz De Tenerife, Spain, 38009
        • Hospital Universitario Nuestra Señora La Candelaria
      • Segovia, Spain, 40002
        • Hospital General de Segovia
      • Sevilla, Spain, 41014
        • Hospital De Valme
      • Tarragona, Spain, 43003
        • Hospital De Sant Pau i Sta. Tecla
      • Toledo, Spain, 45071
        • Hospital Virgen de la Salud
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid
      • Zamora, Spain, 49022
        • Complejo Asistencial de Zamora
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
      • Ávila, Spain, 05004
        • Hospital Nuestra Señora de Sonsoles
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
      • Torrevieja, Alicante, Spain, 03186
        • Hospital de Torrevieja
    • Araba
      • Gasteiz / Vitoria, Araba, Spain, 01009
        • Hospital Universitario Araba-Sede Txagorritxu
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Hospitalet de Llobregat, Barcelona, Spain, 08908
        • ICO Hospitalet
      • Mataró, Barcelona, Spain, 08304
        • Hospital de Mataró
    • Bizkaia
      • Galdakao, Bizkaia, Spain, 48960
        • Hospital Galdakao-Usansolo
    • Ciudad Real
      • Alcázar De San Juan, Ciudad Real, Spain, 13600
        • Hospital La Mancha Centro
    • Cádiz
      • Jerez De La Frontera, Cádiz, Spain, 11407
        • Hospital Universitario Jerez de la Frontera
    • Gran Canaria
      • Las Palmas De Gran Canaria, Gran Canaria, Spain, 35016
        • Hospital Universitario Insular de Gran Canaria
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
        • Hospital San Pedro de Logroño
    • Madrid
      • Leganés, Madrid, Spain, 28911
        • Hospital Universitario Severo Ochoa
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta De Hierro
      • Móstoles, Madrid, Spain, 28935
        • Hospital Universitario de Móstoles
      • Pozuelo De Alarcón, Madrid, Spain, 28223
        • Hospital Universitario Quiron Madrid
    • Tarragona
      • Tortosa, Tarragona, Spain, 43500
        • Hospital Verge de la Cinta
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital Universitario Cruces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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.
From the date of first dose of COVID-19 vaccine through 90 days after the final administration of the drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación GECP

Investigators

  • Study Chair: Ernest Nadal, MD, Fundación GECP Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Actual)

March 28, 2022

Study Completion (Actual)

March 28, 2022

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECP 21/01_VAC-CaP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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