ENOSE in Pulmonary Tuberculosis in Yogyakarta (YOGYATBNOSE)
2017年5月31日 更新者：Tjip van der Werf
The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients
Electronic noses detecting patterns of volatile molecules have recently been introduced for different diagnostic purposes.
The diagnostic accuracy of a prototype e-nose device (Bruins et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%.
Here the investigators test a production type point-of-care hand-held device with less detectors.
The investigators explore factors such as food intake, smoking, and co-morbidity, as well as the impact of TB treatment, and address the question whether the device could help monitor disease and response to treatment.
研究概览
地位
完全的
条件
详细说明
Study participants provide WIC and after time for consideration, when they approve, provide demographic anonymized data.
The study population consists of six groups:
Group 1 - 20 TB patients aged > 18 yrs Group 2 - 20 non---TB patients > 18 yrs (screened for TB - other conditions) Group 3 - 20 patients with a lung disease - no TB suspects (Lung Clinics in Yogyakarta,Indonesia; Group 4 - 50 apparently healthy matched controls Group 5 - 20 newly diagnosed TB patients enrolled before start of treatment, to be followed over time, until after end of treatment (8 months FU).
Group 6 - 50 apparently healthy volunteers.
Study participants breath normally by mouthpiece into the device using a nose clamp - for 5 min during each sampling.
Electronic data are downloaded and transmitted by internet to Zutphen, Netherlands where data are processed to build the model.
研究类型
介入性
注册 (实际的)
389
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Jalan Kesehatan no.1, Yogyakarta
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Yogyakarta、Jalan Kesehatan no.1, Yogyakarta、印度尼西亚、55281
- patients - at 5 lung clinics (Minggiran, Kalasan, Kotagede, Bantul, Kuonprogo) connected with Sudjarto Teachnig Hospital; healthy controls among students and staff of Hospital and Gadjah Mada Universitas
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- age >18yrs
- voluntarily participating
Exclusion Criteria:
-
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group 1 - 20 PTB patients aged >18yrs
Group 1 - 20 TB patients aged > 18 yrs 5 min exhaled breath sampling with nose clamp
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study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc
其他名称：
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实验性的：Group 2 - 20 TB suspects > 18 yrs
Group 2 - 20 non-TB patients > 18 yrs (screened for TB - but appear to test negative for TB, and diagnosed with other conditions including bronchiectasis, etc) 5 min exhaled breath sampling with nose clamp
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study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc
其他名称：
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实验性的：group 3 - 20 lung patients, non-TB
Group 3 - 20 patients with a lung disease - no TB suspects (recruited from Lung Clinics in Yogyakarta; lung cancer, COPD, etc) 5 min exhaled breath sampling with nose clamp
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study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc
其他名称：
|
|
实验性的：Group 4 - 20 healthy controls
Group 4 - 20 apparently healthy matched controls 5 min exhaled breath sampling with nose clamp
|
study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc
其他名称：
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实验性的：Group 5 - 7 newly diagnosedMDR PTB pts
Group 5 - 7 newly diagnosed MDRTB patients enrolled before start of treatment, to be followed 8 months, until after end of treatment 5 min exhaled breath sampling with nose clamp
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study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc
其他名称：
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实验性的：group 6 - cohort of TB suspects
300 more individuals, suspected to have TB - final diagnosis by standard procedures plus sputum culture plus follow-up for >2 years 5 min exhaled breath sampling with nose clamp
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study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc
其他名称：
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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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diagnostic precision of electronic nose signal in pulmonary TB
大体时间：18 months
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sensitivity and specificity of electronic nose signal in diagnosing and measuring response to treatment in pulmonary TB
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18 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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measuring response to TB treatment over time with the electronic nose
大体时间：18 months
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cohort of patients newly deteted with PTB will be followed with the enose device over time to monitor disease activity, until end of treatment
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18 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年11月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2017年4月1日
研究注册日期
首次提交
2014年8月1日
首先提交符合 QC 标准的
2014年8月15日
首次发布 (估计)
2014年8月19日
研究记录更新
最后更新发布 (实际的)
2017年6月1日
上次提交的符合 QC 标准的更新
2017年5月31日
最后验证
2017年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.