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

Recruiting

• Conditions: Gastric Cancer; Atrophic Gastritis; Gastric Dysplasia; H.Pylori Infection

• Registration Number: NCT04022109
• Lead Sponsor: University of Latvia

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.

Study Timeline

• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-12
• Study First Posted: 2019-07-16
• Study Start: 2019-11-01
• Status Verified: 2020-11
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-26
• Primary Completion: 2022-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characteristic VOC pattern identification for gastric cancer detection	2 years following initiation of patient recruitment	The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected
Specific chemistry identification in the exhaled breath	2 years following initiation of patient recruitment	Identification of specific chemistries (GC-MS analysis) originating from gastric cancer

Secondary Outcome Measures

Name	Time	Method
Identification of the best-performing sensors	3 years following initiation of patient recruitment	Comparative analysis between the performance of different sensor performance in target disease identification
Characteristic VOC pattern identification for gastric precancerous lesion detection	2.5 years following initiation of patient recruitment	The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected
Gut microbiota analysis in relation to breath VOCs	3 years following initiation of patient recruitment	Analysis of the role of gastric and faecal microbiota in the origin of VOCs in the exhaled breath

Trial Locations

Locations (5)

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