COVID-19 Vaccination in Oncologic Patients (VINCI)

Krankenhaus Barmherzige Schwestern Linz

Status: Completed

Conditions: Covid19; Oncologic Disorders

Study type: Observational

Funder types: Other

Identifiers

NCT04918888

ECS 1048/2021

Details and patient eligibility

About

Evaluating the vaccination willingness in oncologic patients over six months as well as estimating the effects of radiotherapy/systemic anticancer treatment on the efficacy and toxicity of currently approved SARS-CoV-2 vaccines

Full description

All patients that present themselves newly at the outpatient-clinic of the Department of Radiooncology at the Ordensklinikum Linz GmbH, Barmherzige Schwestern during a period of six months are eligible for participation. After being informed about the study, the participants answer a short structured interview regarding vaccination status and vaccination willingness. Patients who already received one or two doses of SARS-CoV-2 vaccine are eligible for the study's subpopulation 1, with the main focus of quantifying SARS-CoV-2 S binding antibody titres after at least 35 days from initial vaccination. Patients who are to receive at least one dose of vaccine during or up to six weeks after radiotherapy are eligible for subpopulation 2, comprising serial measurements of SARS-CoV-2 S binding antibody titres before and after vaccination.

Enrollment: 1,150 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Study population for the cross-sectional study (patients with previous SARS-CoV-2 infection of previous vaccination, evaluation of willingness to get vaccinated:

• Patients with solid tumors/haematooncologic diseases regardless of stage that seek treatment in the outpatient clinic of the department of radiooncology from April to September 2021 who will undergo active treatment.
• Age: 18-120 years Patients that undergo radiotherapy, radio-chemotherapy, radio-hormonotherapy or radio-immunotherapy during the investigation period.

Longitudinal study:

• Patients that have not yet received SARS-CoV-2 vaccination, but are scheduled to get the first dose during or up to six weeks after active therapy.
• Age: 18-120 years

Exclusion criteria

• Lack of written consent
• Patients, that are mentally or physically incapable of completing a questionnaire
• Age: < 18 years
• A previous SARS-CoV-2 infection is no exclusion criteria!

Trial design

1,150 participants in 3 patient groups

Overall study population

Description:

All new oncologic patients of the outpatient-clinic of the department of radiooncology

First dose received (Subpopulation 1)

Description:

Patients, who received one or two doses of SARS-CoV-2 vaccine prior to radiotherapy

Vaccination during therapy (Subpopulation 2)

Description:

Patients, who will receive at least one dose of SARS-CoV-2 vaccine during or up to 6 weeks after radiotherapy