Covid19, Oncologic Disorders
Conditions
Keywords
radiotherapy, SARS-CoV-2 vaccine, immune response, oncologic therapies, immunosuppression, SARS-CoV-2 S binding antibodies, vaccination willingness, vaccination side effects
Brief summary
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
Detailed 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.
Interventions
None listed
Sponsors
Krankenhaus Barmherzige Schwestern Linz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of vaccination willingness | once directly after enrollment | guided interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 antibody titre in patients vaccinated during antineoplastic treatment | baseline and 7, 14,21,28,35, 182 and 365 days post first dose | Development of antibody titre in patients who received the first or second dose of SARS-CoV-2 vaccine during radiotherapy, Longitudinal quantification of binding antibodies |
| Qualitive assessment of reasons to reject vaccination | once directly after enrollment | guided interview |
| Qualitive assessment of comorbidities | once after enrollment prior to vaccination | (in respect of the gravity of a SARS-CoV-2 infection corresponding to the WHO-grading), guided interview |
| Kind and dosage of accompanying systemic therapies | once after enrollment | — |
| SARS-CoV-2 antibody titre in already vaccinated patients | >= 35 days post first dose | — |
| Previous SARS-CoV-2 infection (Rate of undetected cases via antibody detection, for known previous disease: evaluation of severity) | once directly after enrollment and ev. at >= 35 days after first dose | guided interview, conducted again at day 35 after the first dose for patients who receive radiotherapy during the first dose of vaccination |
| Qualitative and quantitative assessment of local/systemic side effects of the SARS-CoV-2 vaccination | 35 days after vaccination | questionnaire |
| incidence of a symptomatic SARS-CoV-2 infection (duration, extent and severity) | 35 days after vaccination | questionnaire |
| Modalities and duration of the radiotherapy (irradiated region, single dose overall dose) | once after enrollment | — |
Countries
Austria
Outcome results
None listed