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

Gastric Cancer Clinical Trial

— VOGAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04022109
• Other study ID #: 824986
• Secondary ID: lzp-2018/2-0228K
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: December 2026

Study information

• Verified date: November 2020
• Source: University of Latvia
• Contact: Marcis Leja, MD, PhD
• Phone: +37129497500
• Email: marcis.leja[@]lu.lv
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2026
• Est. primary completion date: December 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophic Gastritis
• Atrophy
• Gastric Cancer
• Gastric Dysplasia
• Gastritis
• Gastritis, Atrophic
• H.Pylori Infection
• Stomach Neoplasms

Intervention

Device:
• 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

Procedure:
• Surgery material collection for VOC headspace analysis
Only for gastric cancer patients undergoing surgery (Group 1)

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Brazil	A.C.Camargo Cancer Center	São Paulo
Chile	Pontificia Universidad Catolica de Chile	Santiago
Colombia	Centro Javeriano de Oncología, San Ignacio University Hospital	Bogotá
Latvia	Institute of Clinical and Preventive Medicine, University of Latvia	Riga
Ukraine	National Cancer Institute of Ukraine	Kiev

Sponsors (12)

Lead Sponsor	Collaborator
University of Latvia	AC Camargo Cancer Center, Hospital Universitario San Ignacio, JLM Innovation GmbH, National Cancer Institute of Ukraine, Pontificia Universidad Catolica de Chile, Technion, Israel Institute of Technology, Universidad de Pamplona, Universitaet Innsbruck, University of Ulm, Uppsala University, VTT Technical Research Centre of Finland

Countries where clinical trial is conducted

Brazil,  Chile,  Colombia,  Latvia,  Ukraine, 

References & Publications (6)

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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Secondary	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
Secondary	Identification of the best-performing sensors	Comparative analysis between the performance of different sensor performance in target disease identification	3 years following initiation of patient recruitment
Secondary	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

External Links

•   Horizon 2020 project VOGAS web-page