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.
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.
Study Type
OBSERVATIONAL
Enrollment
2,022
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for microbiota testing
Colonoscopy with proper biopsy or polypectomy material work-up will be used for identification and stratification of colorectal lesions as well as acquisition of biopsies for microbiota testing
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
The material obtained during surgery (stomach or colorectal) will be used for confirmation of the diagnosis in cancer groups. Surgery itself will be performed according to the clinical indications, and will not be extended (i.e. cannot be considered a study intervention)
University of Latvia
Riga, Latvia
Lithuanian University of Health Sciences
Kaunas, Lithuania
Performance of nanoarray sensor testing to detect target lesions
Sensitivity, specificity, overall accuracy of nanoarray sensor testing for VOCs to detect the target lesions in the blinded analysis
Time frame: At the time of breath sampling
VOCs differentiating the study groups
List of VOCs assayed by GC-MS with statistical difference between the study groups
Time frame: At the time of breath sampling
Identification of characteristic VOC pattern in risk age groups
List of characteristic VOCs in general population at risk for developing gastrointestinal cancer, including analysis of confounding factors, e.g. dietary habits, smoking, and profession.
Time frame: At the time of sampling
VOC pattern changes following treatment
Significant change in VOC content before and following treatment (surgery, medical therapy, combined)
Time frame: At baseline and every 6 months within 3 year period
Groups of gastrointestinal microbiota correlating to VOCs
List of gastrointestinal microbiota groups (phylum/genus level) with positive correlation to particular VOCs
Time frame: At the time of sampling
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