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临床试验/NCT01994681
NCT01994681Unknown不适用

Testing Spectrosense EVA System for Detection of Pancreatic 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 100 人开始时间: 2013年10月最近更新:
适应症

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

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

研究者

发起方
Rauscher, Gregory E., M.D. PA
申办方类型
Indiv
责任方
Sponsor

研究点 (1)

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