Breathomics: May it Become an Affordable, New Tool for Early Diagnosis and Screening of Lung Cancer? An Exploratory Study on a Cohort of 60 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in VOCs peaks in patients with lung cancer vs healthy patients
研究概览
简要总结
Breath analysis examining specific patterns of volatile organic compounds (VOCs) has been demonstrated to be able to discriminate lung cancer (LC) patients from healthy controls (HC). However, the existing technology uses complex, expensive, and low throughput analytical platforms to give an offline response, thus preventing its applicability for mass screening. The reliability of a new portable device to enable rapid, on-site LC diagnosis is tested.
详细描述
The breath of patients with histologically proven NSCLC and healthy controls was sampled into Tedlar bags through a Nafion filter and a one-way mouthpiece. The breath samples in the bags were then analyzed by an automated micro portable gas chromatography device developed in-house, which consisted of a thermal desorption tube, thermal injector, separation column, and photoionization detector, as well as other accessories such as pumps, valves, and a helium cartridge. The chromatograms were analyzed by chemometrics and machine learning techniques.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC histologically proven (for LC group) at any stage of disease
- •non-cancer controls who had negative findings on preoperative chest X-rays/chest CT scan (for HC groups)
排除标准
- •Patients who had any history of another type of cancer
- •who had received neoadjuvant chemo/radiotherapy because of the possible unknown effects on cancer metabolism
- •pediatric patients.
结局指标
主要结局
Changes in VOCs peaks in patients with lung cancer vs healthy patients
时间窗: 24 hours
Identify biomarkers able to discriminate between lung cancer patients and healthy controls.
次要结局
未报告次要终点