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Completed

NCT Number: NCT05009030

Anti-SARS-COV2 Vaccination Study in Lung Cancer Patients

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.

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Key information

Conditions

Lung Cancer COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Respiratory Tract Neoplasms Thoracic Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario De Santiago, Santiago de Compostela, A Coruña, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Fundación GECP

Other

Registry information

Official study title

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

Acronym: VAC-CaP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 17, 2021
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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