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| ID | Type | Description | Link |
|---|---|---|---|
| LZP Nr. 2014.10-5 | Other Identifier | Latvian Research Council |
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| Name | Class |
|---|---|
| Technion, Israel Institute of Technology | OTHER |
| Lithuanian University of Health Sciences | OTHER |
| Karolinska Institutet | OTHER |
| German Cancer Research Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Colorectal cancer | Patients with histologically confirmed colorectal cancer (adenocarcinoma) |
| |
| 2. Colorectal high-risk lesions | Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions. |
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| 3. Colorectal low-risk adenoma | Patients without colorectal adenocarcinoma and without colorectal high-risk lesions as described under Group 2 criteria |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath sampling for volatile marker detection | Procedure | Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | At the time of breath sampling |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the time of sampling |
| VOC pattern changes following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| VOC pattern changes following intervention to microbiota | Significant change in VOC content before and following intervention upon microbiome (antibiotic intake, colon cleansing) | At baseline and following the intervention (1 week, 1 month) |
| Gastric microbiome changes following intervention to microbiota |
Inclusion Criteria:
Exclusion Criteria:
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Cancer patients (Group 1 and 5) will be predominantly enrolled at the time scheduled for surgery, however also patients undergoing diagnostic procedures (endoscopy) will be eligible
Patients without malignant disease but defined colorectal (Groups 2-4) status will be predominantly enrolled prior colonoscopy in out-patient settings. Sampling starting from 1 week after colonoscopy will be allowed if the lesions will not get removed during the index endoscopy
Patients without malignant disease but defined gastric mucosal status (Groups 6-8) status will be predominantly enrolled prior upper endoscopy in out-patient settings. Sampling starting from 2 days after upper endoscopy will be allowed if the lesions will not get removed during the index endoscopy
Average cancer risk subjects (Group 9) will get enrolled by inviting individuals predominantly selected from the lists of general practitioners.
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| Name | Affiliation | Role |
|---|---|---|
| Hossam Haick, Ph.D. | Technion, Israel Institute for Technology (Israel) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Latvia | Riga | LV 1586 | Latvia | |||
| Lithuanian University of Health Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24305596 | Background | 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. | |
| 23462808 | Background | 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. |
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| OTHER |
| Digestive Diseases Centre GASTRO | OTHER |
| Riga East Clinical University Hospital | OTHER_GOV |
| Academic Histology Laboratory (Latvia) | OTHER |
| JLM Innovation GmbH (Germany) | UNKNOWN |
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Exhaled air samples being stored in specific adsorbent media Plasma/serum samples for group stratification Faecal samples for occult blood testing and microbiota analysis Biopsy samples from stomach and colon
| 5. Gastric cancer | Patients with histologically confirmed gastric cancer (adenocarcinoma) |
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| 6. Gastric dysplasia | Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach |
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| 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) |
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| 8. Normal and low-risk gastric lesions | Staged 0-III according to OLGIM. Dysplasia should be excluded |
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| 9. Average risk population | Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer. |
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| Upper endoscopy with biopsies | Procedure | 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 |
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| Colonoscopy with biopsies or lesion removal when required | Procedure | 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 |
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| Plasma/serum sampling | Procedure | Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination |
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| Faecal sample acquisition | Procedure | Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis |
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| Histological evaluation of the surgery material | Procedure | 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) |
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Significant change in VOC content before and following treatment (surgery, medical therapy, combined) |
| 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 | At the time of sampling |
Significant change in gastric microbiome (phyla, genera) before and following intervention upon microbiome (antibiotic intake) |
| At baseline and 3 years after intervention |
| Gastrointestinal microbiome in cancer patients | Significant differences in the composition of gastric and colonic microbiome (phyla, genera) in cancer patients, patients with precancerous lesions and controls | At the time of sampling |
| Kaunas |
| LT 44307 |
| Lithuania |
| 24184568 | Background | 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. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D010437 | Peptic Ulcer |
| D005757 | Gastritis, Atrophic |
| D005770 | Gastrointestinal Neoplasms |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
| D004378 | Duodenal Diseases |
| D005756 | Gastritis |
| D005759 | Gastroenteritis |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D005773 | Gastroscopy |
| D001706 | Biopsy |
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |
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