Siemens VOC TB Pilot Study
Pattern Recognition of Volatile Organic Compounds (VOC) in Exhaled Breath for the Diagnosis of Pulmonary Tuberculosis
Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide. Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis require advanced and expensive diagnostic methods that restrict their availability in resource limited countries where the burden of tuberculosis is highest. The development of rapid point of care diagnostics is required.
Published data confirm that trained African giant-pouched rats are able to identify M. tuberculosis cultures through olfactory recognition. A first trial using an electronic nose reported a rate of detection of 85% in tuberculosis patients. A further trial was closed in June 2011 but remains unpublished, yet. The olfactory pattern that potentially allows the recognition of tuberculosis remains unknown.
This trial aims to detect first patterns of volatile organic compounds (VOCs) that bear a potential for further development and fine tuning. A technical prototypic device of Siemens is used for pattern detection.
The study is comparing 3 groups of patients:
- patients with confirmed active pulmonary tuberculosis (n=20)
- patients with other inflammatory lung diseases (pneumonia, sarcoidosis, COPD, bronchial carcinoma) (n=20)
- healthy volunteers that do not work in the hospital or visit the hospital regularly Detailed data for all study subjects will be collected for this trial in order to eliminate confounding factors. Furthermore, detailed data of the surroundings of the patient, the surroundings of the technical device and of the operator will be captured.
Hypothesis:
The pattern of exhaled volatile organic compounds allows the detection of pulmonary tuberculosis
研究概览
地位
条件
研究类型
注册 (预期的)
联系人和位置
学习地点
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Schleswig-Holstein
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Borstel、Schleswig-Holstein、德国、23845
- Research Center Borstel
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Confirmed pulmonary infection with M. tuberculosis (MTB) or other inflammatory disease of the lower respiratory tract (i.e. pneumonia, sarcoid, bronchial carcinoma) or healthy subject that is not employed or working at the study site
- Oral and written consent to study participation
Exclusion Criteria:
- Tuberculosis therapy >1 week
- Inability to follow the study requirements
- Patient in custodianship or guardianship
- Other lung diseases that are not listed in the inclusion criteria.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Tuberculosis group
Patients with confirmed pulmonary infection with M. tuberculosis.
At least 50% of the subjects should be tested before therapy is started.
Patients with treatment for tuberculosis >1 week are excluded.
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Inflammation group
Patients with another inflammatory disease of the lower respiratory tract, i.e. pneumonia, sarcoid or bronchial carcinoma.
This group is required to detect VOC pattern caused by pulmonary inflammation.
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Healthy group
Healthy subjects without lung disease.
These subjects should be recruited from outside the hospital / study site to avoid confounding VOC pattern caused by continuous exposure to the hospital environment.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of correctly identified patients with tuberculosis
大体时间:Day of admission to hospital
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The VOC pattern is used to differentiate tuberculosis patients from patients with non-tuberculosis inflammatory lung disease and from healthy volunteers
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Day of admission to hospital
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change in VOC pattern induced by storage for several days
大体时间:At days 3, 5 and 7 after sample collection
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At days 3, 5 and 7 after sample collection
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Change in VOC pattern induced by storage temperature
大体时间:At days 3, 5 and 7 after sample collection
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At days 3, 5 and 7 after sample collection
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Change in VOC pattern induced by tuberculosis therapy
大体时间:After completion of recruitment
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After completion of recruitment
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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