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临床试验/NCT02106117
NCT02106117已完成不适用

The Application of an Electronic Nose in the Early Detection of Aspergillosis II

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年12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
120
试验地点
2
主要终点
molecular profiles in exhaled breath

研究概览

简要总结

Although the clinical outcome in patients with Invasive Aspergillosis (IA) is largely dependent on early initiation of effective treatment with antifungal drugs, diagnosing IA is still a critical problem. Symptoms are non-specific and available diagnostic tools are either invasive or have low sensitivity and specificity. This often results in a diagnostic delay, with patients developing more extensive disease. Furthermore, as long as IA is present, oncological follow-up treatment is not feasible. Inaccuracy in diagnosing IA can cause serious treatment delay and increased mortality. However, an empirical strategy with prophylactic anti-mould therapy is not feasible considering both possible side effects and costs. In order to safely continue the use of a pre-empirical strategy, improved (non-invasive) diagnostic tools are desirable.

In a pilot study de Heer et al. showed that it is possible to discriminate between patients with IA and their neutropenic controls by exhaled breath analysis using an electronic nose (eNose). In this study the investigators aim to test whether an eNose could be useful as a diagnostic tool in a prospective setting.

The gold standard in exhaled breath analysis is Gas Chromatography - Mass Spectrometry (GC-MS). This technique enables identification of volatile organic compounds (VOCs) in breath of patients. It is possible that there are Aspergillus specific VOCs in the breath of patients with IA.

The composition of the lung microbiome seems to be an important factor in both health and disease. It is likely that the microbiome of the lung changes in prolonged neutropenia, therefore possibly creating a niche for molds and yeasts. Comparing the microbiome of patients with prolonged neutropenia who develop IA with those who do not, can learn us more about the pathogenesis of this disease. This knowledge could be used to investigate new treatment options for Invasive Aspergillosis.

Hypothesis The investigators hypothesize that airway microbial (viral, bacterial) presence and exhaled molecular profiles as obtained from patients with prolonged neutropenia due to treatment of hematological malignancies, are different between patients who develop IA and patients who do not.

详细描述

Aims

  1. To compare the exhaled molecular profiles (GC-MS and eNose) between neutropenic patients who develop IA and neutropenic controls.
  2. To investigate whether exhaled molecular profiles can serve as surrogate to predict IA at an early stage.
  3. To compare the alterations in the viral/bacterial microbial profiles during the neutropenic episode between patients who develop IA and controls.
  4. To examine the relationship between microbial and molecular profiles in order to generate mechanistic hypotheses.

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

入选标准

  • Patients are:
  • aged 18 years or older;
  • diagnosed with a hematological malignancy;
  • treatment is expected to result in prolonged (>7 days) neutropenia (<0.5 x 10^9/L)
  • able to give written and dated informed consent prior to any study specific procedures.

排除标准

  • Patients are unable to perform the breathing manoeuvre needed for eNose-analysis of exhaled air

结局指标

主要结局

molecular profiles in exhaled breath

时间窗: 2 years

Exhaled molecular profiles (by eNose and GC-MS) and the accuracy with which serial analysis of these profiles can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls in terms of sensitivity, specificity and accuracy of the predictive algorithm. Breath will be collected twice weekly during the neutropenic episode, resulting in an average of 5 exhaled breath measurements (eNose as well as GC-MS) per patient. Approximately 150 patients will be included for exhaled breath analysis.

次要结局

  • Microbiome analysis of throat swabs(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

prof dr M.H.J. van Oers

prof. dr. M.H.J. van Oers

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (2)

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