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

Sponsor

Fundación GECP (Other)

Overall Status

Completed

CT.gov ID

NCT05009030

Collaborator

(none)

794

Enrollment

Locations

10.7

Actual Duration (Months)

15.6

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Covid19	Drug: COVID-19 vaccine

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 Design

Study Type:

Observational

Actual Enrollment :

794 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 6, 2021

Actual Primary Completion Date :

Mar 28, 2022

Actual Study Completion Date :

Mar 28, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Determine the efficacy of the COVID19 vaccine [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
Incidence of COVID-19 vaccine-Emergent Adverse Events (Safety and Tolerability) [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 Outcome Measures

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]
Analyze patients who become infected with COVID-19 after being vaccinated
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]
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Complejo Hospitalario Universitario De Santiago	Santiago De Compostela	A Coruña	Spain	15706
2	Hospital General Universitario de Elche	Elche	Alicante	Spain	03203
3	Hospital De Torrevieja	Torrevieja	Alicante	Spain	03186
4	Hospital Universitario Araba-Sede Txagorritxu	Gasteiz / Vitoria	Araba	Spain	01009
5	Hospital Germans Trias I Pujol	Badalona	Barcelona	Spain	08916
6	ICO Hospitalet	Hospitalet de Llobregat	Barcelona	Spain	08908
7	Hospital De Mataro	Mataró	Barcelona	Spain	08304
8	Hospital Galdakao-Usansolo	Galdakao	Bizkaia	Spain	48960
9	Hospital La Mancha Centro	Alcázar De San Juan	Ciudad Real	Spain	13600
10	Hospital Universitario Jerez De La Frontera	Jerez De La Frontera	Cádiz	Spain	11407
11	Hospital Universitario Insular de Gran canaria	Las Palmas De Gran Canaria	Gran Canaria	Spain	35016
12	Hospital San Pedro De Logroño	Logroño	La Rioja	Spain	26006
13	Hospital Universitario Severo Ochoa	Leganés	Madrid	Spain	28911
14	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid	Spain	28222
15	Hospital Universitario De Mostoles	Móstoles	Madrid	Spain	28935
16	Hospital Universitario Quiron Madrid	Pozuelo De Alarcón	Madrid	Spain	28223
17	Hospital Verge De La Cinta	Tortosa	Tarragona	Spain	43500
18	Hospital Universitario Cruces	Barakaldo	Vizcaya	Spain	48903
19	Hospital Universitario De A Coruna	A Coruña		Spain	15006
20	Hospital General Universitario de Alicante	Alicante		Spain	03010
21	Hospital Universitari Quiron Dexeus	Barcelona		Spain	08028
22	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041
23	Hospital de Basurto	Bilbao		Spain	48013
24	ICO Girona, Hospital Josep Trueta	Girona		Spain	17007
25	Hospital Universitario Virgen De Las Nieves	Granada		Spain	18014
26	Hospital San Cecilio	Granada		Spain	18016
27	Hospital Universitario de Jaén	Jaén		Spain	23007
28	Hospital Universitario de León	León		Spain	24071
29	Hospital Universitario Lucus Augusti	Lugo		Spain	27003
30	Hospital Universitario Infanta Leonor	Madrid		Spain	28031
31	Hospital Clínico San Carlos	Madrid		Spain	28040
32	Hospital 12 De Octubre	Madrid		Spain	28041
33	Hospital Universitario HM Sanchinarro	Madrid		Spain	28050
34	Hospital Fundación de Alcorcón	Madrid		Spain	28922
35	Hospital General Universitario de Málaga	Málaga		Spain	29010
36	Hospital Universitari Son Llatzer	Palma De Mallorca		Spain	07198
37	Complejo Hospitalario Pontevedra	Pontevedra		Spain	36071
38	Hospital Clínico de Salamanca	Salamanca		Spain	37007
39	Hospital Universitario Nuestra Señora La Candelaria	Santa Cruz De Tenerife		Spain	38009
40	Hospital General De Segovia	Segovia		Spain	40002
41	Hospital De Valme	Sevilla		Spain	41014
42	Hospital De Sant Pau i Sta. Tecla	Tarragona		Spain	43003
43	Hospital Virgen De La Salud	Toledo		Spain	45071
44	Instituto Valenciano De Oncología	Valencia		Spain	46009
45	Hospital General Universitario de Valencia	Valencia		Spain	46014
46	Hospital Universitario Dr. Peset	Valencia		Spain	46017
47	Hospital Universitario La Fe	Valencia		Spain	46026
48	Hospital Clínico Universitario de Valladolid	Valladolid		Spain	47003
49	Complejo Asistencial De Zamora	Zamora		Spain	49022
50	Hospital Miguel Servet	Zaragoza		Spain	50009
51	Hospital Nuestra Señora De Sonsoles	Ávila		Spain	05004

Sponsors and Collaborators

Fundación GECP

Investigators

Study Chair: Ernest Nadal, MD, Fundación GECP Investigator

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Fundación GECP

ClinicalTrials.gov Identifier:

NCT05009030

Other Study ID Numbers:

GECP 21/01_VAC-CaP

First Posted:

Aug 17, 2021

Last Update Posted:

Jul 29, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fundación GECP

COVID-19 vaccine

Additional relevant MeSH terms:

COVID-19

Lung Neoplasms

Study Results

No Results Posted as of Jul 29, 2022