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临床试验/NCT02781857
NCT02781857已完成不适用

Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Patients With Lung Cancer

University of Zurich2 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
309
试验地点
2
主要终点
Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry

研究概览

简要总结

To answer the question whether a disease specific profile of breath in patients with lung cancer can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Confirmed lung cancer based on cytological or histological analysis.
  • Group A: any type of lung cancer eligible for surgical resection (up to TNM stage IIIa).
  • Group B: any type of lung cancer (small-cell carcinoma, non-small-cell carcinoma) not amenable for surgical resection.
  • Group C: matched controls.
  • Age between 18 and 85 years at study entry

排除标准

  • Another 'active' secondary malignant disease (e.g. breast cancer, colon carcinoma) in group A and B, presence of any active malignant disease in group C (based on personal information).
  • Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
  • Any other acute lung disease which affects breath measurements
  • Acute or chronic hepatic disease.
  • Renal failure or renal replacement therapy.

结局指标

主要结局

Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry

时间窗: 1 day, single measurement

The primary outcome will be the lung cancer specific mass spectrometric profile of VOCs of exhaled breath analysis (markers of lung cancer in exhaled breath).

次要结局

  • Group A: Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry before and after lung cancer surgery(Group A: 2 measurements on 2 different days; Day 1: 1. measurement (before surgery), Day 2: (6-12 weeks after surgery): 2. measurement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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