Hepatitis E Virus Infection in Oncological Patients - a Prospective Study in Rural Eastern Germany
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Anti HEV-IgM and IgG prevalences
研究概览
简要总结
The goal of this clinical trial is to investigate the prevalence of hepatitis E infection in oncological patients in a rural region of Germany. Consequently, we conducted prospective testing of blood samples from patients with haematological malignancies for evidence of HEV infection using two distinct anti-HEV IgG and IgM enzyme-linked immunosorbent assays (ELISAs). Serum was taken from each patient before treatment initiation and during treatment follow-up. Primary endpoint was determination of HEV seroprevalence. A healthy cohort was established alongside a cohort of patients who had been hospitalised due to a diagnosis of SARS-CoV-2 infection. In addition, oncological participants completed a questionnaire consisting of eight questions focusing on quantitative aspects, to identify risk factors for HEV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •different hemato-oncological entities without age restriction
排除标准
- •patients already receiving antineoplastic therapies
- •not given written consent
结局指标
主要结局
Anti HEV-IgM and IgG prevalences
时间窗: In the oncological cohort, multiple samples were prospectively collected over a one-year period, commencing on 1 September 2020 and concluding at the end of October 2021. In the remaining two control samples, analysis was conducted retrospectively.
Anti-HEV prevalences were determined in each arm with two different assays
次要结局
- Identification of risk factors for HEV infection in oncological patients(The questionnaire was handed out at the beginning of the study)
研究者
Isabel-Elena Haller
MD
Medizinische Hochschule Brandenburg Theodor Fontane