Volatile Marker Testing for Digestive Cancer and Precancerous Lesion Detection, Evaluation of Confounding Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,022
- 试验地点
- 2
- 主要终点
- Performance of nanoarray sensor testing to detect target lesions
研究概览
简要总结
The study is aimed to determine the potential of volatile marker testing for identification of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related precancerous lesions in the stomach and colon.
The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.
详细描述
Patients with established disease (cancer, precancerous lesions) as well as patients investigated for the lesions and having been documented lack of the lesions will be enrolled to the study at clinical sites in Europe (Latvia, Lithuania). In addition, group of persons from general population at average risk for developing the target disease will be also enrolled.
Testing of volatile markers will be conducted by one of two methods: 1) gas chromatography coupled to mass spectroscopy (GS-MS) and 2) nanosensor technology.
Volunteers (including patients with established disease) will be enrolled prior the removal of the target lesion (e.g. surgery for cancer or polypectomy in the case of a polyp).
The study will be conducted by utilizing the experience of institutions in the European Union and Israel.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Patients with verifies colorectal cancer (Group 1)
- •Patients with verified gastric cancer (Group 5)
- •Patients undergoing colonoscopy due to clinical indications (group 2-4)
- •Patients undergoing upper endoscopy due to clinical indications (Group 6-8)
- •Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 9)
- •Motivation to participate in the study
- •Physical status allowing volatile marker sampling and other procedures within the protocol
- •Signed consent
排除标准
- •Known other active cancer
- •Ventilation problems, airway obstruction
- •Unwillingness or inability to co-operate
结局指标
主要结局
Performance of nanoarray sensor testing to detect target lesions
时间窗: At the time of breath sampling
Sensitivity, specificity, overall accuracy of nanoarray sensor testing for VOCs to detect the target lesions in the blinded analysis
VOCs differentiating the study groups
时间窗: At the time of breath sampling
List of VOCs assayed by GC-MS with statistical difference between the study groups
次要结局
- VOC pattern changes following treatment(At baseline and every 6 months within 3 year period)
- Identification of characteristic VOC pattern in risk age groups(At the time of sampling)
- Groups of gastrointestinal microbiota correlating to VOCs(At the time of sampling)