NCT04022109

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: University of Latvia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Gastric Cancer
• Atrophic Gastritis
• Gastric Dysplasia
• H.Pylori Infection

Interventions

Type	Name	Description
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)
DIAGNOSTIC_TEST	Microbiota testing	Faecal and gastric contents and biopsy samples for microbiota testing

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-12-01
• Completion: 2026-12-01
• First posted: 2019-07-16
• Last updated: 2021-07-26

Locations

5 sites across 5 countries: Brazil, Chile, Colombia, Latvia, Ukraine