SARS-CoV-2 Vaccination in Oncologic Patients: A Prospective, Explorative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,150
- 试验地点
- 2
- 主要终点
- Quantification of vaccination willingness
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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!
结局指标
主要结局
Quantification of vaccination willingness
时间窗: once directly after enrollment
guided interview
次要结局
- 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)
- 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)
- Qualitive assessment of reasons to reject vaccination(once directly after enrollment)
- Qualitive assessment of comorbidities(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)
- incidence of a symptomatic SARS-CoV-2 infection (duration, extent and severity)(35 days after vaccination)
- Qualitative and quantitative assessment of local/systemic side effects of the SARS-CoV-2 vaccination(35 days after vaccination)