NCT01849328Unknown不适用
Testing Spectrosense EVA System for Detection of Breast Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air
Rauscher, Gregory E., M.D. PA1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2013年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 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 Breast Cancer sick population and healthy population. breast cancer.
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 Breast Cancer sick population and healthy population. The gold standard for identifying sick/healthy population is biopsy proven breast 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
- Female
- 接受健康志愿者
- 是
入选标准
- •Age from 18 years old
- •Breast cancer positive biopsy
- •Before any treatment
- •Signed Informed Patient Consent
排除标准
- •Age under 18 years old
- •Neoadjovant treatment
- •Post surgery for breast cancer
- •A history of any other cancer type, except skin cancer that is not melanoma
- •Healthy group:
- •Inclusion Criteria:
- •Healthy women
- •No history of Breast cancer
- •Signed Informed Patient Consent
- •Exclusion Criteria:
- •History of Breast cancer
- •Breast 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 Breast Cancer sick population and healthy population. breast cancer.
时间窗: Upon enrollment.
次要结局
未报告次要终点
研究者
研究点 (1)
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