Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Процедура Surgery material collection for VOC headspace analysis
  Only for gastric cancer patients undergoing surgery (Group 1)
• Диагностический тест 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)
• Диагностический тест Microbiota testing
  Faecal and gastric contents and biopsy samples for microbiota testing

Первичные конечные точки

• Characteristic VOC pattern identification for gastric cancer detection [Срок оценки: 2 years following initiation of patient recruitment]
• Specific chemistry identification in the exhaled breath [Срок оценки: 2 years following initiation of patient recruitment]

Вторичные конечные точки (3)

• Characteristic VOC pattern identification for gastric precancerous lesion detection [Срок оценки: 2.5 years following initiation of patient recruitment]
• Identification of the best-performing sensors [Срок оценки: 3 years following initiation of patient recruitment]
• Gut microbiota analysis in relation to breath VOCs [Срок оценки: 3 years following initiation of patient recruitment]

Критерии участия

Критерии включения

• Patients with verified gastric cancer (Group 1 \& 2)
• 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

Критерии исключения

• Known other active cancer
• Ventilation problems, airway obstruction
• Unwillingness or inability to co-operate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бразилия · 1 центр

• A.C.Camargo Cancer Center — São Paulo

Чили · 1 центр

• Pontificia Universidad Catolica de Chile — Santiago

Колумбия · 1 центр

• Centro Javeriano de Oncología, San Ignacio University Hospital — Bogotá

Латвия · 1 центр

• Institute of Clinical and Preventive Medicine, University of Latvia — Riga

Украина · 1 центр

• National Cancer Institute of Ukraine — Kiev

Публикации

• 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. PMID 29893713
• 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. PMID 29528036
• 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. PMID 25869737
• 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. PMID 26440312
• 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. PMID 25439074
• 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. PMID 27341527

Идентификаторы

NCT: NCT04022109 · 824986 · lzp-2018/2-0228 · KC-L-2017/5

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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