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临床试验/NCT02361281
NCT02361281Unknown不适用

Validation of a Previously Performed Study on Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath

Maastricht University0 个研究点目标入组 50 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
diagnosis by exhaled breath

研究概览

简要总结

Sarcoidosis is a chronic lung disease that is characterized by fatigue, shortness of breath, chest pain and reduced lung function. Suffering from these diseases has a very negative effect on the quality of life. When people are suspected of having sarcoidosis various markers in the blood are measured. Ultimate diagnosis, however, always requires invasive techniques such as bronchoscopy and lung biopsy. Consequently, there is an urgent need for a new diagnostic tool that is easy, quick and most of all non-invasive and thus friendly for the patient.

Such a new diagnostic tool might be found in examining the exhaled air of patients, which contains a complex mixture of so-called volatile organic compounds (VOCs) that are the result of damaging processes that occur in the lung. Determining the VOC profile in the breath can be used as a biomarker, or biological indicator, of those damaging processes. In other words, searching for unique VOC profiles in the breath of sarcoidosis patients might lead to the development of a diagnostic tool that only uses their exhaled breath.

The current study involves 25 sarcoidosis patients and 25 healthy volunteers. The aim of this study is find VOCs in exhaled air that can be used to diagnose sarcoidosis. In a previous study, sarcoidosis-specific VOCs were found, which we intend to validate using the current study.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with confirmed sarcoidosis

排除标准

  • (ex-) smokers
  • for healthy controls: controls with pulmonary disease excluded

结局指标

主要结局

diagnosis by exhaled breath

时间窗: upon regular visit to clinic, which is expected to occur on average within 4 months after the start of the study

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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