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.
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.
Study Type
OBSERVATIONAL
Enrollment
5,000
Breath sampling will be performed by using a special sensor device and or GC-MS analysis (by collecting breath samples in adsorbent tubes). Pepsinogen testing will be used in a subgroup to identify serological increased risk for atrophy
Only for gastric cancer patients undergoing surgery (Group 1)
Routine endoscopic evaluation with a standard biopsy work-up according to updated Sydney system. Additional gastric contents for GC-MS and microbiota analysis in a subgroup. Endoscopy will be used only according to the clinical indications (in Group 4 - according to the results of pepsinogen tests)
A.C.Camargo Cancer Center
São Paulo, Brazil
RECRUITINGPontificia Universidad Catolica de Chile
Santiago, Chile
NOT_YET_RECRUITINGCentro Javeriano de Oncología, San Ignacio University Hospital
Bogotá, Colombia
NOT_YET_RECRUITINGCharacteristic VOC pattern identification for gastric cancer detection
The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected
Time frame: 2 years following initiation of patient recruitment
Specific chemistry identification in the exhaled breath
Identification of specific chemistries (GC-MS analysis) originating from gastric cancer
Time frame: 2 years following initiation of patient recruitment
Characteristic VOC pattern identification for gastric precancerous lesion detection
The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected
Time frame: 2.5 years following initiation of patient recruitment
Identification of the best-performing sensors
Comparative analysis between the performance of different sensor performance in target disease identification
Time frame: 3 years following initiation of patient recruitment
Gut microbiota analysis in relation to breath VOCs
Analysis of the role of gastric and faecal microbiota in the origin of VOCs in the exhaled breath
Time frame: 3 years following initiation of patient recruitment
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Faecal and gastric contents and biopsy samples for microbiota testing
Institute of Clinical and Preventive Medicine, University of Latvia
Riga, Latvia
RECRUITINGNational Cancer Institute of Ukraine
Kiev, Ukraine
RECRUITING