NCT01395446已完成不适用
The Application of an Electronic Nose in the Early Detection of ASpergillosis
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2010年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever
研究概览
简要总结
The purpose of this study is to establish the accuracy with which the eNose can discriminate patients with invasive pulmonary aspergillosis from controls.
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
- 是
入选标准
- •Patients that
- •are 18 years of age or older
- •will undergo treatment for a hematological malignancy expected to result in grade 4 neutropenia (according to CTCAE 3.0, i.e. <0.5 x 109 neutrophils/L) of prolonged duration (i.e., more than 7 days), e.g. hematopoietic stem cell transplantation or induction/consolidation treatment for acute myeloid leukaemia
- •have given written informed consent
排除标准
- •a previously diagnosed invasive mycosis
- •the inability to perform the breathing manoeuvre needed for eNose-analysis of exhaled air
结局指标
主要结局
accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever
时间窗: 4 days
The cross-validated accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever, defined as the percentage of correctly classified patients using the leave-one out method
次要结局
未报告次要终点
研究者
K. de Heer
Drs. K. de Heer
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
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