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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall study population | All new oncologic patients of the outpatient-clinic of the department of radiooncology | ||
| First dose received (Subpopulation 1) | Patients, who received one or two doses of SARS-CoV-2 vaccine prior to radiotherapy | ||
| Vaccination during therapy (Subpopulation 2) | Patients, who will receive at least one dose of SARS-CoV-2 vaccine during or up to 6 weeks after radiotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Quantification of vaccination willingness | guided interview | once directly after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 antibody titre in already vaccinated patients | >= 35 days post first dose | |
| SARS-CoV-2 antibody titre in patients vaccinated during antineoplastic treatment | 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 |
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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:
Longitudinal study:
Exclusion Criteria:
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new patients of the department for radiooncology at the Ordensklinikum Barmherzige Schwestern Linz
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| Name | Affiliation | Role |
|---|---|---|
| Hans Geinitz, Univ.-Prof. | Ordensklinikum Linz GmbH, Barmherzige Schwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern | Linz | Upper Austria | 4010 | Austria | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38246842 | Derived | Geinitz H, Silberberger E, Spiegl K, Feichtinger J, Wagner H, Hermann P, Brautigam E, Track C, Weis EM, Venhoda C, Huppert R, Spindelbalker-Renner B, Zauner-Babor G, Nyiri DV, Karasek N, Erdei M, Gheju R, Gruber G, Egger M, Dieplinger B. SARS-CoV-2 vaccination willingness and humoral vaccination response in radiation oncology patients. Vaccine. 2024 Feb 6;42(4):945-959. doi: 10.1016/j.vaccine.2024.01.006. Epub 2024 Jan 20. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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serum samples
| baseline and 7, 14,21,28,35, 182 and 365 days post first dose |
| Qualitive assessment of reasons to reject vaccination | guided interview | once directly after enrollment |
| Qualitive assessment of comorbidities | (in respect of the gravity of a SARS-CoV-2 infection corresponding to the WHO-grading), guided interview | once after enrollment prior to vaccination |
| Kind and dosage of accompanying systemic therapies | once after enrollment |
| Modalities and duration of the radiotherapy (irradiated region, single dose overall dose) | once after enrollment |
| Previous SARS-CoV-2 infection (Rate of undetected cases via antibody detection, for known previous disease: evaluation of severity) | guided interview, conducted again at day 35 after the first dose for patients who receive radiotherapy during the first dose of vaccination | once directly after enrollment and ev. at >= 35 days after first dose |
| Qualitative and quantitative assessment of local/systemic side effects of the SARS-CoV-2 vaccination | questionnaire | 35 days after vaccination |
| incidence of a symptomatic SARS-CoV-2 infection (duration, extent and severity) | questionnaire | 35 days after vaccination |
| Ordensklinikum Linz GmbH, Barmherzige Schwestern |
| Linz |
| Upper Austria |
| 4010 |
| Austria |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |