Testing Spectrosense EVA System for Detection of Pancreatic Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Obtaining a set or sets of VOC bio-markers that will provide the best discrimination between Pancreatic Cancer sick population and healthy population.
研究概览
简要总结
Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the Spectrosense EVA system, which is combination of a gas chromatography (GC) and software algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the best discrimination between Pancreatic Cancer sick population and healthy population. The gold standard for identifying sick/healthy population is biopsy proven Pancreatic cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age from 18 years old
- •Pancreatic cancer positive biopsy
- •Before any treatment
- •Signed Informed Patient Consent
排除标准
- •Age under 18 years old
- •Neoadjovant treatment
- •Post surgery for Pancreatic cancer
- •A history of any other cancer type, except skin cancer that is not melanoma
- •Healthy Group
- •Inclusion Criteria:
- •Healthy patients
- •No history of Pancreatic cancer
- •Signed Informed Patient Consent
- •Exclusion Criteria:
- •History of Pancreatic cancer
- •Pancreatic cancer background in the family
- •A history of any other cancer type, except skin cancer that is not melanoma
结局指标
主要结局
Obtaining a set or sets of VOC bio-markers that will provide the best discrimination between Pancreatic Cancer sick population and healthy population.
时间窗: Baseline
An optimization algorithm will select VOCs that will provide maximal sensitivity and specificity.
次要结局
未报告次要终点
