Épidémiologie Clinique et caractéristiques Des Cas de Covid-19 Survenus Dans un Contexte de Lymphome Lors de la première Phase épidémique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
The main objective of this retrospective clinical epidemiology study is to describe the characteristics of Covid-19 cases requiring hospitalization in adult patients with lymphomas during the initial phase of the epidemic (from 01/03/20 to 30/04/20).
The specific objectives are to estimate the frequency of severe forms of Covid-19 and those requiring intensive care hospitalisation, as well as the mortality related to the epidemic among the active file of patients followed for lymphoma at each study site, to investigate whether certain chemotherapy and/or immunotherapy treatments seem to be associated with severe forms or prolonged evolutions of Covid-19, to describe possible atypical clinical forms among the population of patients treated for lymphoma.
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详细描述
I
Methods :
- Multicentric retrospective observational epidemiological study based on the collection of data from patient records.
- Selection of voluntary hospital sites in regions with excess mortality during the epidemic phase.
- Systematic identification of Covid-19 cases from coding data (PMSI) from the medical information departments which will be compared with the numbers of patients followed for lymphoma in the haematology departments of each site during the 6 months preceding the epidemic, identified through the PMSI.
- Establishment of an ad hoc CRF for cases only with collection of clinical data concerning lymphoma and Covid-19 and routine biological data: Cytopenia (and in particular depth of lymphopenia), hypogammaglobulinemia, inflammatory markers.
- Estimated total number of sites: 10-15 and number of cases to be collected: 50-60.
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研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients at least 18 years of age with lymphoma and a diagnosis of Covid-19 requiring hospitalization.
- •In order not to bias the data by excluding patients with adverse outcomes, we will also collect data from deceased patients.
排除标准
- •Patients who refused to participate
结局指标
主要结局
mortality
时间窗: 2 months
transfer to ICU
时间窗: 2 months
次要结局
未报告次要终点
研究者
Caroline BESSON
investigator MD
Versailles Hospital