Immunity Against Severe Acute Respiratory Syndrome Coronavirus 2 Disease (COVID-19) in the Oncology Outpatient Setting: Prevalence and Serological Immunity in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Rate of SARS-CoV-2 antibody positive patients
研究概览
简要总结
The COVIDOUT study will prospectively investigate the serological immunity of outpatient cancer patients to evaluate the prevalence of previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and dependency of serological immunity on systemic (chemo)therapy after COVID19 disease as well as after vaccination.
详细描述
In this prospective observational study all cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE) will be included in the study upon consent.
Data will be collected as follows:
(i) Serological antibody screening at study inclusion and every 3 months (ia) In case of vaccination monthly screening for 3 months (ii) Routine clinical data: demographic and biometric data, medical history, common laboratory parameters (iii) Patient questionnaire: assessment of past COVID-19 infection, past COVID-19 specific symptoms, social environment, vaccination
Recruitment is limited to a one-year period (December 2020 - December 2021)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known diagnosis of cancer
- •Active disease or (in case of cure) last systemic therapy <12 months
- •Signed informed consent
排除标准
- •Refusal of participation
结局指标
主要结局
Rate of SARS-CoV-2 antibody positive patients
时间窗: 1 year
Measured in percentage
Rate of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 vaccinated patients
时间窗: Up to 1 year
Measured in percentage
Rate of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 antibody positive patients
时间窗: Up to 1 year
Measured in percentage
次要结局
- Rate of therapy modalities in SARS-CoV-2 antibody positive patients(1 year)
- Subgroup analysis of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 vaccinated patients(Up to 1 year)
- Rate of unknown prior COVID19 disease in SARS-CoV-2 antibody positive patients(1 year)
- Rate of cancer entities in SARS-CoV-2 antibody positive patients(1 year)
- Rate of re-infection in SARS-CoV-2 antibody positive patients(1 year)