Spots Global Cancer Trial Database for Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach

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Trial Identification

Brief Title: Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach

Official Title: Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach

Study ID: NCT04022109

Conditions

Interventions

Breath sampling for VOC detection

Surgery material collection for VOC headspace analysis

Upper endoscopy

Microbiota testing

Study Description

Brief Summary: 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.

Detailed Description: 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.