COVID-19 Disease in Cancer Patients: Evaluation of Clinical Course and Impact on Oncological Care in the Hamburg Metropolitan Area Including Prospective Biobanking
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Duration of hospitalization
研究概览
简要总结
The COVIDHELP study will prospectively evaluate the yet unknown clinical course of the COVID-19 infection in cancer patients and document the impact of potential infrastructural limitations on cancer care of COVID-19 positive patients. All patients consenting will provide peripheral blood samples for prospective biobanking with the aim of investigating immune response and immunity against COVID-19.
详细描述
Based on patients, who are treated in the University Cancer Center Hamburg (UCCH) and its contracted partner network, which comprises all cancer treating departments at the University Medical Center of Hamburg-Eppendorf (UKE), as well as 19 office-based oncologists and 20 surrounding hospitals, recruitment for the study will be done as follows:
(i) as a cancer patient during regular aftercare appointments who reports a current or past COVID-19 infection.
(ii) as an acute COVID-19 patient who reports a prevalent cancer diagnosis
Data will be collected as available from routine clinical care and includes demographic and biometric data, medical history, baseline data at inclusion as well as inpatient and intensive care unit admissions. Upon consent, patients will provide peripheral blood samples at time of inclusion and after 6 month. Recruitment is limited to a one-year period (April 2020 - April 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Duration of hospitalization
时间窗: 2 years
Measured in days from date of admission to definitive discharge
Rate of hospitalization
时间窗: 2 years
Measured in percentage
Rate of admission to intensive care unit
时间窗: 2 years
Measured in percentage
Length of stay in intensive care unit
时间窗: 2 years
Measured in days from date of admission to intensive care unit to the date of discharge
Need of mechanical ventilation
时间窗: 2 years
Measured in percentage
Duration of mechanical ventilation
时间窗: 2 years
Measured in days from the date of intubation to the stop date of mechanical ventilation
Disease-specific mortality rate
时间窗: 2 years
COVID-19 associated mortality rate
次要结局
- Rate of patients, whose oncologic treatment had to be modified due to COVID-19(2 years)
- Cellular and humoral immune response to COVID-19 infection(6 month)