Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 5
- 主要终点
- Characteristic VOC pattern identification for gastric cancer detection
研究概览
简要总结
The study is aimed to determine the potential of volatile marker testing for gastric cancer screening.
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 (gastric 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, Ukraine) and Latin America (Colombia, Chile, Brazil). In addition, group of persons from general population at average risk for developing the target disease and individuals being referred for upper endoscopy according to clinical indications 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) sensor technology. Various sensors will be used and evaluated for the purpose.
The potential sources of volatile organic compounds (VOCs) in the breath will be addressed by studying VOC emission by using headspace analysis from cancer tissue, gastric contents, cancer cell cultures and H.pylori.
The potential role of gastric and faecal microbiota in the origin of VOCs in the breath will be addressed. Metabolome in the circulation will also get correlated to VOCs in the breath and with microbiome.
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
- 否
入选标准
- •Patients with verified gastric cancer (Group 1 & 2)
- •Patients undergoing or having undergone upper endoscopy according to clinical indications (Group 3 & 5)
- •Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 4)
- •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
Characteristic VOC pattern identification for gastric cancer detection
时间窗: 2 years following initiation of patient recruitment
The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected
Specific chemistry identification in the exhaled breath
时间窗: 2 years following initiation of patient recruitment
Identification of specific chemistries (GC-MS analysis) originating from gastric cancer
次要结局
- Identification of the best-performing sensors(3 years following initiation of patient recruitment)
- Characteristic VOC pattern identification for gastric precancerous lesion detection(2.5 years following initiation of patient recruitment)
- Gut microbiota analysis in relation to breath VOCs(3 years following initiation of patient recruitment)
研究者
Marcis Leja
Director, Institute of Clinical and Preventive Medicine
University of Latvia