Colorectal Cancer, Colorectal Adenoma, Gastric Cancer, Peptic Ulcer Disease, Atrophic Gastritis, Intestinal Metaplasia, H.Pylori Infection, Normal Control, Average-risk General Population
Conditions
Keywords
Volatile organic compounds, Nanosensor technology, GC-MS, Breath-testing, Digestive cancer, Precancerous lesions, Colorectal cancer, Adenoma, Gastric cancer, Atrophic gastritis, OLGIM
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBreath sampling for volatile marker detection
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
PROCEDUREUpper endoscopy with biopsies
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
PROCEDUREColonoscopy with biopsies or lesion removal when required
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
PROCEDUREPlasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
PROCEDUREFaecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
PROCEDUREHistological evaluation of the surgery material
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)
Sponsors
Technion, Israel Institute of Technology
Lithuanian University of Health Sciences
Karolinska Institutet
German Cancer Research Center
Digestive Diseases Centre GASTRO
Riga East Clinical University Hospital
Academic Histology Laboratory (Latvia)
JLM Innovation GmbH (Germany)
University of Latvia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Known other active cancer * Ventilation problems, airway obstruction * Unwillingness or inability to co-operate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of nanoarray sensor testing to detect target lesions | 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 | At the time of breath sampling | List of VOCs assayed by GC-MS with statistical difference between the study groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VOC pattern changes following treatment | At baseline and every 6 months within 3 year period | Significant change in VOC content before and following treatment (surgery, medical therapy, combined) |
| Identification of characteristic VOC pattern in risk age groups | At the time of sampling | 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. |
| Groups of gastrointestinal microbiota correlating to VOCs | At the time of sampling | List of gastrointestinal microbiota groups (phylum/genus level) with positive correlation to particular VOCs |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gastric microbiome changes following intervention to microbiota | At baseline and 3 years after intervention | Significant change in gastric microbiome (phyla, genera) before and following intervention upon microbiome (antibiotic intake) |
| Gastrointestinal microbiome in cancer patients | At the time of sampling | Significant differences in the composition of gastric and colonic microbiome (phyla, genera) in cancer patients, patients with precancerous lesions and controls |
| VOC pattern changes following intervention to microbiota | At baseline and following the intervention (1 week, 1 month) | Significant change in VOC content before and following intervention upon microbiome (antibiotic intake, colon cleansing) |
Countries
Latvia, Lithuania
Outcome results
None listed