Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Differences in Breath Spectra of Lung Cancer, Stable Pulmonary Nodules, and Controls
研究概览
简要总结
The goal of this clinical trial is to compare breath samples from patients with lung cancer, those with stable lung nodules, and individuals without lung cancer. The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in patients with lung cancer.
Participants will be asked to provide one breath sample, and two if they get treated. They will also be asked to fill out a questionnaire about their background and medical history.
详细描述
Globally, lung cancer accounts for the most cancer deaths in both sexes combined. It is believed to develop slowly through progressive accumulation of genetic mutations, hence the disease allows time for diagnosis and curative surgical treatment. Five year survival rates for non-small-cell lung carcinoma (NSCLC) can range from 57-61% when detected in the early stages of disease. This is compared with a survival rate of approximately 6% once distant metastases are present. However, disease diagnosis typically occurs when it has progressed to an advanced stage when patients present with signs and symptoms. Therefore, technologies capable of asymptomatic disease detection will significantly impact lung cancer specific mortality. Metabolomic profiling of cancer measures compounds produced as a result of cellular activity including volatile organic compounds (VOCs) in exhaled breath. Infrared spectroscopy is a proven technique for breath analysis that can measure chemical concentrations in the parts per trillion range for certain VOCs. When coupled with machine learning techniques, this has the potential to be a novel approach for disease detection using exhaled breath.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study participants in the lung cancer and control cohorts must meet lung cancer screening criteria as defined by the PLCOm2012 and/or US Preventative Services Task Force (USPSTF) risk criteria.
排除标准
- •Patients are not eligible if they are currently receiving treatment for lung cancer.
- •Patients are not eligible for a second breath sample if it has been less than 6 months since last application of treatment.
- •Note: Breath sampling technology is sensitive to chemicals produced by tobacco, cannabis and e-cigarettes as well as alcohol (consumed by the subject or used by the operator around the equipment). We ask participants to refrain from:
- •Smoking (tobacco, cannabis or e-cigarettes) at least 4 hours before breath sampling;
- •Consume alcohol (including mouthwash) at least 8 hours before breath sampling.
结局指标
主要结局
Differences in Breath Spectra of Lung Cancer, Stable Pulmonary Nodules, and Controls
时间窗: 2 years
Using infrared cavity-ringdown spectroscopy, breath spectra of volatile organic compounds (VOCs) will be measured. Breath spectra will be statistically analyzed to identify features specific to each of the respective cohorts. These features will be used to train mathematical and statistical models to differentiate and categorize the samples within the three cohorts.
次要结局
- Differences in breath spectra of patients with lung cancer before and after treatment(2 years)