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| ID | Type | Description | Link |
|---|---|---|---|
| lzp-2018/2-0228 | Other Grant/Funding Number | Latvia Research Council | |
| KC-L-2017/5 | Other Grant/Funding Number | Investment and Development Agency of Latvia |
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| Name | Class |
|---|---|
| Technion, Israel Institute of Technology | OTHER |
| University of Ulm | OTHER |
| Uppsala University | OTHER |
| JLM Innovation GmbH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric cancer patients undergoing surgery | Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management |
| |
| Gastric cancer patients | Patients with histologically confirmed gastric cancer (adenocarcinoma) |
| |
| Control group patients without gastric cancer | Patients without gastric malignant disease according to data obtained in upper endoscopy |
| |
| Average risk population | Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer |
| |
| Patients with dyspeptic symptoms |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath sampling for VOC detection | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Characteristic VOC pattern identification for gastric cancer detection | The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected | 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 | 2 years following initiation of patient recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Characteristic VOC pattern identification for gastric precancerous lesion detection | The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected | 2.5 years following initiation of patient recruitment |
| Identification of the best-performing sensors |
| Measure | Description | Time Frame |
|---|---|---|
| Confounding factor analysis | The role of confounding factors will be addressed to address their role in VOC emission | 3 years following initiation of patient recruitment |
Inclusion Criteria:
Exclusion Criteria:
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Cancer patient population will be recruited in the major specialized cancer centres in Europe (Latvia, Ukraine) and Latin America (Colombia, Chile, Brazil) Control group patients will be recruited in the major specialized endoscopy centres in Europe (Latvia, Ukraine) and Latin America (Colombia, Chile, Brazil), most frequently - the same institutions as for cancer patient recruitment General population group (40-64 years) will be predominantly recruited in Latvia from the general population Symptomatic patient validation cohort (Group 5) will be predominantly recruited in Chile from the endoscopy referrals
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcis Leja, MD, PhD | Contact | +37129497500 | marcis.leja@lu.lv | |
| Daiga Santare, MD, PhD | Contact | +37129221107 | daiga.santare@lu.lv |
| Name | Affiliation | Role |
|---|---|---|
| Hossam Haick, PhD | TECHNION, Israel Institute for Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.C.Camargo Cancer Center | Recruiting | SĂŁo Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29893713 | Background | Mochalski P, Leja M, Gasenko E, Skapars R, Santare D, Sivins A, Aronsson DE, Ager C, Jaeschke C, Shani G, Mitrovics J, Mayhew CA, Haick H. Ex vivo emission of volatile organic compounds from gastric cancer and non-cancerous tissue. J Breath Res. 2018 Jul 30;12(4):046005. doi: 10.1088/1752-7163/aacbfb. | |
| 29528036 | Background |
| Label | URL |
|---|---|
| Horizon 2020 project VOGAS web-page | View source |
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| UNKNOWN |
| Universitaet Innsbruck | OTHER |
| Hospital Universitario San Ignacio | OTHER |
| Universidad de Pamplona | OTHER |
| Pontificia Universidad Catolica de Chile | OTHER |
| AC Camargo Cancer Center | OTHER |
| National Cancer Institute of Ukraine | OTHER |
| VTT Technical Research Centre of Finland | OTHER |
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Exhaled air samples being stored in specific adsorbent media Plasma/serum samples for group stratification Biopsy samples from stomach for histological assessment and microbiota analysis Gastric content samples for GC-MS and microbiota analysis Faecal samples for occult blood testing and microbiota analysis
Patients with dyspeptic symptoms or other complains being referred for upper endoscopy (Chile)
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| Surgery material collection for VOC headspace analysis | Procedure | Only for gastric cancer patients undergoing surgery (Group 1) |
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| Upper endoscopy | Diagnostic Test | 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) |
|
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| Microbiota testing | Diagnostic Test | Faecal and gastric contents and biopsy samples for microbiota testing |
|
Comparative analysis between the performance of different sensor performance in target disease identification |
| 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 | 3 years following initiation of patient recruitment |
| Pontificia Universidad Catolica de Chile | Not yet recruiting | Santiago | Chile |
|
| Centro Javeriano de OncologĂa, San Ignacio University Hospital | Not yet recruiting | Bogotá | Colombia |
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| Institute of Clinical and Preventive Medicine, University of Latvia | Recruiting | Riga | LV1050 | Latvia |
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| National Cancer Institute of Ukraine | Recruiting | Kiev | Ukraine |
|
| Krilaviciute A, Stock C, Leja M, Brenner H. Potential of non-invasive breath tests for preselecting individuals for invasive gastric cancer screening endoscopy. J Breath Res. 2018 Apr 4;12(3):036009. doi: 10.1088/1752-7163/aab5be. |
| 25869737 | Background | Amal H, Leja M, Funka K, Skapars R, Sivins A, Ancans G, Liepniece-Karele I, Kikuste I, Lasina I, Haick H. Detection of precancerous gastric lesions and gastric cancer through exhaled breath. Gut. 2016 Mar;65(3):400-7. doi: 10.1136/gutjnl-2014-308536. Epub 2015 Apr 13. |
| 26440312 | Background | Krilaviciute A, Heiss JA, Leja M, Kupcinskas J, Haick H, Brenner H. Detection of cancer through exhaled breath: a systematic review. Oncotarget. 2015 Nov 17;6(36):38643-57. doi: 10.18632/oncotarget.5938. |
| 25439074 | Background | Leja M, You W, Camargo MC, Saito H. Implementation of gastric cancer screening - the global experience. Best Pract Res Clin Gastroenterol. 2014 Dec;28(6):1093-106. doi: 10.1016/j.bpg.2014.09.005. Epub 2014 Sep 28. |
| 27341527 | Background | Leja M, Amal H, Lasina I, Skapars R, Sivins A, Ancans G, Tolmanis I, Vanags A, Kupcinskas J, Ramonaite R, Khatib S, Bdarneh S, Natour R, Ashkar A, Haick H. Analysis of the effects of microbiome-related confounding factors on the reproducibility of the volatolomic test. J Breath Res. 2016 Jun 24;10(3):037101. doi: 10.1088/1752-7155/10/3/037101. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D005757 | Gastritis, Atrophic |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D005756 | Gastritis |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| D005773 | Gastroscopy |
| 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 |
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