Study Results
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Basic Information
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COMPLETED
2022 participants
OBSERVATIONAL
2014-01-31
2017-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1. Colorectal cancer
Patients with histologically confirmed colorectal cancer (adenocarcinoma)
Breath sampling for volatile marker detection
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Colonoscopy 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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Histological 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)
2. Colorectal high-risk lesions
Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) sizeā„1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions.
Breath sampling for volatile marker detection
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Colonoscopy 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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
3. Colorectal low-risk adenoma
Patients without colorectal adenocarcinoma and without colorectal high-risk lesions as described under Group 2 criteria
Breath sampling for volatile marker detection
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Colonoscopy 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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
4. Group of control (colorectal)
Patients having undergone colonoscopy without an evidence for colorectal lesions fulfilling Group 1 or Group 2 or Group 3 criteria. Prior to removal of the lesions.
Breath sampling for volatile marker detection
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Colonoscopy 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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
5. Gastric cancer
Patients with histologically confirmed gastric cancer (adenocarcinoma)
Breath sampling for volatile marker detection
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Upper 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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Histological 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)
6. Gastric dysplasia
Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach
Breath sampling for volatile marker detection
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Upper 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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
7. High-risk gastric lesions
Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, but excluding those with dysplasia (Group 5)
Breath sampling for volatile marker detection
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Upper 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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
8. Normal and low-risk gastric lesions
Staged 0-III according to OLGIM. Dysplasia should be excluded
Breath sampling for volatile marker detection
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Upper 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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
9. Average risk population
Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer.
Breath sampling for volatile marker detection
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Interventions
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Breath sampling for volatile marker detection
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Upper 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
Colonoscopy 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
Plasma/serum sampling
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal sample acquisition
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
Histological 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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Ventilation problems, airway obstruction
* Unwillingness or inability to co-operate
18 Years
ALL
Yes
Sponsors
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Technion, Israel Institute of Technology
OTHER
Lithuanian University of Health Sciences
OTHER
Karolinska Institutet
OTHER
German Cancer Research Center
OTHER
Digestive Diseases Centre GASTRO
OTHER
Riga East Clinical University Hospital
OTHER_GOV
Academic Histology Laboratory (Latvia)
OTHER
JLM Innovation GmbH (Germany)
UNKNOWN
University of Latvia
OTHER
Responsible Party
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Principal Investigators
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Hossam Haick, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Technion, Israel Institute for Technology (Israel)
Locations
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University of Latvia
Riga, , Latvia
Lithuanian University of Health Sciences
Kaunas, , Lithuania
Countries
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References
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Haick H, Broza YY, Mochalski P, Ruzsanyi V, Amann A. Assessment, origin, and implementation of breath volatile cancer markers. Chem Soc Rev. 2014 Mar 7;43(5):1423-49. doi: 10.1039/c3cs60329f. Epub 2013 Dec 4.
Xu ZQ, Broza YY, Ionsecu R, Tisch U, Ding L, Liu H, Song Q, Pan YY, Xiong FX, Gu KS, Sun GP, Chen ZD, Leja M, Haick H. A nanomaterial-based breath test for distinguishing gastric cancer from benign gastric conditions. Br J Cancer. 2013 Mar 5;108(4):941-50. doi: 10.1038/bjc.2013.44.
Amal H, Leja M, Broza YY, Tisch U, Funka K, Liepniece-Karele I, Skapars R, Xu ZQ, Liu H, Haick H. Geographical variation in the exhaled volatile organic compounds. J Breath Res. 2013 Dec;7(4):047102. doi: 10.1088/1752-7155/7/4/047102. Epub 2013 Nov 1.
Other Identifiers
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LZP Nr. 2014.10-5
Identifier Type: OTHER
Identifier Source: secondary_id
2914
Identifier Type: -
Identifier Source: org_study_id
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