NCT02965300Unknown不适用
The Value of VOCs Analysis in Exhaled Breath for Pulmonary Benign and Malignant Lesion Diagnosis
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2016年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Mass-to-charge Ratio
研究概览
简要总结
The purpose of this study is to analysis the volatile organic gases(VOCs) in exhaled breath of pulmonary lesion patients and healthy controls, in order to find the difference of composition and concentration among groups.
详细描述
Collect the exhaled gas in pulmonary lesion patients and healthy controls, using proton transfer reaction mass spectrometry to analysis the different composition and concentration of VOCs, to find the biomarker gases of distinguishing benign and malignant lesion of lung among different groups， and try to build a diagnostic model for lung lesion.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •cohort 1 :
- •Inclusion criteria:
- •Patients newly diagnosed with primary lung cancer by tissue biopsy and did not receive any treatment aiming at the tumor, including chemotherapy and radiotherapy.
- •Age ≥ 18 years
- •cohort 2： Inclusion criteria： Patients diagnosed with pulmonary benign lesion by tissue biopsy or other examination.
- •Age ≥ 18 years
排除标准
- •patients who have more than one type of carcinoma patients diagnosed type 2 diabetes mellitus patients diagnosed chronic renal failure patients diagnosed upper digestive tract ulcer patients who reject to sign the informed consent from
- •cohort 3： Healthy controls Volunteers without diagnosed lung diseases and pulmonary symptoms.
结局指标
主要结局
Mass-to-charge Ratio
时间窗: 6 months
It is the measurement result of VOCs in exhaled breath using PTR-MS device.
次要结局
未报告次要终点
研究者
Chen Liang_An
MD,PHD
Chinese PLA General Hospital
研究点 (1)
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