Clinical trial NCT04022109: Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
Official title: Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Atrophic Gastritis
Gastric Dysplasia
H.Pylori Infection
Keywords: Volatile organic compounds
Breath testing
Gastric cancer
Atrophic gastritis
Precancerous lesions
Screening
Nanosensor technology
GC-MS
Lead sponsor: University of Latvia
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
name: University of Ulm
name: Uppsala University
name: JLM Innovation GmbH
name: Universitaet Innsbruck
name: Hospital Universitario San Ignacio
name: Universidad de Pamplona
name: Pontificia Universidad Catolica de Chile
name: AC Camargo Cancer Center
name: National Cancer Institute of Ukraine
name: VTT Technical Research Centre of Finland
First posted: 2019-07-16
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Characteristic VOC pattern identification for gastric cancer detection
timeFrame: 2 years following initiation of patient recruitment
measure: Specific chemistry identification in the exhaled breath
timeFrame: 2 years following initiation of patient recruitment
Secondary outcomes:
measure: Characteristic VOC pattern identification for gastric precancerous lesion detection
timeFrame: 2.5 years following initiation of patient recruitment
measure: Identification of the best-performing sensors
timeFrame: 3 years following initiation of patient recruitment
measure: Gut microbiota analysis in relation to breath VOCs
timeFrame: 3 years following initiation of patient recruitment
Other outcomes:
measure: Confounding factor analysis
timeFrame: 3 years following initiation of patient recruitment
Locations:
city: São Paulo
country: Brazil
facility: A.C.Camargo Cancer Center
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
city: Bogotá
country: Colombia
facility: Centro Javeriano de Oncología, San Ignacio University Hospital
city: Riga
country: Latvia
facility: Institute of Clinical and Preventive Medicine, University of Latvia
city: Kiev
country: Ukraine
facility: National Cancer Institute of Ukraine
Study officials:
affiliation: TECHNION, Israel Institute for Technology
name: Hossam Haick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.