Early Detection of Lung Cancer - Exhaled Breath Nano-Analysis
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
研究概览
简要总结
Analysis of volatile organic compounds (VOCs) is a new attractive non-invasive field in medical diagnostics. These VOCs can be detected via the exhaled breath.
Together with Prof Haick group at the Technion Inst (Israel), the investigators data shows that there is a relation between the VOCs patterns of NSCLC and control cell lines and equivalent states in exhaled breath. The investigators demonstrated that there is a clear discrimination between the lung cancer and the healthy clusters . The investigators also analyzed the headspace of NSCLC and SCLC cell lines and the investigators could discriminate significantly between SCLC versus NSCLC based on their VOCs patterns. This analysis allowed us to identify the specific VOCs consumed or omitted by cancerous cells. Therefore, a non-invasive and highly sensitive test would be extremely valuable for the classification and early screening of lung cancer and for targeted therapy. In this study, the investigators will monitor the VOC pattern of patients with lung cancer as well as high risk cohort and patients under risk/evaluation for lung cancer. Likewise the investigators will monitor pts under and after therapy. In addition, the investigators will compare teh breath signature to other biomarkers of lung cancer, like circulating tumor cells and others.
详细描述
Scientific background:
Lung cancer is the most lethal cancer, responsible for 28% of cancer deaths and killing ~1.3 million people worldwide every year. Diagnosis and treatment of lung cancer in its early stages could increase the 5-year-survival rate 3-4 fold with a potential for cure4, 7. Therefore, the main goal of this study is early detection of lung cancer, and specifically focusing on the volatile biomarkers of lung cancer that will assist in easy, inexpensive diagnosis based on our previous findings.
Currently available diagnostic tests of lung cancer are not suitable for screening, are extremely costly and involve invasive procedures (e.g. bronchoscopy), that are not free of complications. The goal of cancer screening is to detect tumors at an early stage in order to give treatment a better chance of success. Recently, the biggest lung cancer screening trial (NLST) has shown a mortality benefit of 21% per 5 years study favor low dose CT screening protocol compare to chest X-rays1. Therefore, there is an urgent requirement for a tool to allow a better definition of the high-risk cohort. Such a tool might be a panel of biomarkers.
Focusing on the volatile biomarkers of lung cancer, our group has recently defined a volatile VOCs signature that can distinguish the breath of lung cancer patients from the breath of healthy individuals and from cancerous cells 2, 9. These significant findings have led us to the understanding that volatile biomarkers would fit for early detection of lung cancer and for discrimination between subtypes of lung cancer. Such discrimination will have significant implications on clinical decisions and on patients' benefits.
Exhaled Breath Analysis as a Diagnostic Tool and Preliminary results:
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供