Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection
试验速览
- 阶段
- 不适用
- 发起方
- Hopital Foch
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Comparison of Volatil Organic Compound (VOC) profiles by mass spectrometry
研究概览
简要总结
Bronchopulmonary cancer, with 39 000 new cases and 30 000 deaths per year, is a main issue in public health in France. It is the leading cause of cancer death in France. A lot of progress in medical care has been made, but surgery remains the most effective treatment, when it is still possible. The goal is to detect and manage the lung cancer as early as possible. Alongside screening strategies by annual thoracic scanner, new approaches with innovative technologies open up for cancer detection and therapeutic follow-up.
The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The volatolomic analysis can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.
The composition of VOC in exhaled air and sweat is altered in patients with lung cancer. The VOC analysis and their variation could be used particularly in the follow-up of patients treated for lung cancer.
The purpose of this clinical research is to identify the VOCs related to lung cancers by comparing the VOC profiles in exhaled air and in sweat from patients diagnosed with localized lung cancer before and after resection surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged ≥ 18 years old
- •Patient with non-small cell lung cancer
- •Operable grade I or II
- •No specific treatment before surgery (radiotherapy, chemotherapy or targeted therapy)
- •Patient with healthcare insurance
- •Non Inclusion Criteria:
- •Treatment with radiotherapy, chemotherapy, or neoadjuvant cancer targeted therapy before thoracic surgery
- •Patient with oxygen therapy or invasive ventilation
- •Patient unable to perform a slow vital capacity
- •Dermatological therapy interfering with sweat collection (psoriasis, irritant dermatitis, for instance)
- •Pregnant women
- •Patient deprived of liberty by judicial or administrative decision
排除标准
- 未提供
结局指标
主要结局
Comparison of Volatil Organic Compound (VOC) profiles by mass spectrometry
时间窗: change from baseline profiles at 2 month post-surgery
Comparison of variation in Volatil Organic Compound (VOC) profiles in exhaled air of patients before and after surgery. The VOC will be identified by their molecular mass (by the mass spectrometry)
Comparison of Volatil Organic Compound (VOC) profiles in by electronic noses
时间窗: change from baseline profiles at 2 month post-surgery
Comparison of variation in Volatil Organic Compound (VOC) profiles in exhaled air of patients before and after surgery. The VOC will be identified by the sensor deflection (by the electronic noses).
次要结局
- Comparison of Volatil Organic Compound (VOC) profiles in sweat(30 days before the surgery and 45 to 75 days after surgery)
- Variation of Volatil Organic Compound (VOC) and relapse rate(30 days before the surgery, 45 to 75 days after surgery and 2 years)
- Correlation between Volatil Organic Compound (VOC) profiles and relapse rate(2 months and 2 years after surgery)
- Comparison of Volatil Organic Compound (VOC) profiles in exhaled air and tumoral lung tissue(30 days before the surgery, day of surgery and 45 to 75 days after surgery)