Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
NCT ID: NCT04022109
Last Updated: 2021-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2019-11-01
2026-12-31
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) 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Gastric cancer patients undergoing surgery
Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management
Breath sampling for VOC detection
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
Surgery material collection for VOC headspace analysis
Only for gastric cancer patients undergoing surgery (Group 1)
Upper endoscopy
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)
Microbiota testing
Faecal and gastric contents and biopsy samples for microbiota testing
Gastric cancer patients
Patients with histologically confirmed gastric cancer (adenocarcinoma)
Breath sampling for VOC detection
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
Upper endoscopy
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)
Microbiota testing
Faecal and gastric contents and biopsy samples for microbiota testing
Control group patients without gastric cancer
Patients without gastric malignant disease according to data obtained in upper endoscopy
Breath sampling for VOC detection
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
Upper endoscopy
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)
Microbiota testing
Faecal and gastric contents and biopsy samples for microbiota testing
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 VOC detection
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
Upper endoscopy
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)
Microbiota testing
Faecal and gastric contents and biopsy samples for microbiota testing
Patients with dyspeptic symptoms
Patients with dyspeptic symptoms or other complains being referred for upper endoscopy (Chile)
Breath sampling for VOC detection
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
Upper endoscopy
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)
Microbiota testing
Faecal and gastric contents and biopsy samples for microbiota testing
Interventions
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Breath sampling for VOC detection
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
Surgery material collection for VOC headspace analysis
Only for gastric cancer patients undergoing surgery (Group 1)
Upper endoscopy
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)
Microbiota testing
Faecal and gastric contents and biopsy samples for microbiota testing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients undergoing or having undergone upper endoscopy according to clinical indications (Group 3 \& 5)
* Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 4)
* 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
No
Sponsors
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Technion, Israel Institute of Technology
OTHER
University of Ulm
OTHER
Uppsala University
OTHER
JLM Innovation GmbH
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
University of Latvia
OTHER
Responsible Party
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Marcis Leja
Director, Institute of Clinical and Preventive Medicine
Principal Investigators
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Hossam Haick, PhD
Role: PRINCIPAL_INVESTIGATOR
TECHNION, Israel Institute for Technology
Locations
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A.C.Camargo Cancer Center
São Paulo, , Brazil
Pontificia Universidad Catolica de Chile
Santiago, , Chile
Centro Javeriano de Oncología, San Ignacio University Hospital
Bogotá, , Colombia
Institute of Clinical and Preventive Medicine, University of Latvia
Riga, , Latvia
National Cancer Institute of Ukraine
Kiev, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Related Links
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Horizon 2020 project VOGAS web-page
Other Identifiers
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lzp-2018/2-0228
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KC-L-2017/5
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
824986
Identifier Type: -
Identifier Source: org_study_id
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