Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
- Conditions
- Gastric CancerAtrophic GastritisGastric DysplasiaH.Pylori Infection
- Interventions
- Device: Breath sampling for VOC detectionProcedure: Surgery material collection for VOC headspace analysisDiagnostic Test: Upper endoscopyDiagnostic Test: Microbiota testing
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- 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
- Known other active cancer
- Ventilation problems, airway obstruction
- Unwillingness or inability to co-operate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Gastric cancer patients undergoing surgery Breath sampling for VOC detection Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management Gastric cancer patients undergoing surgery Surgery material collection for VOC headspace analysis Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management Gastric cancer patients undergoing surgery Upper endoscopy Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management Gastric cancer patients undergoing surgery Microbiota testing Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management Gastric cancer patients Breath sampling for VOC detection Patients with histologically confirmed gastric cancer (adenocarcinoma) Gastric cancer patients Upper endoscopy Patients with histologically confirmed gastric cancer (adenocarcinoma) Gastric cancer patients Microbiota testing Patients with histologically confirmed gastric cancer (adenocarcinoma) Control group patients without gastric cancer Breath sampling for VOC detection Patients without gastric malignant disease according to data obtained in upper endoscopy Control group patients without gastric cancer Upper endoscopy Patients without gastric malignant disease according to data obtained in upper endoscopy Control group patients without gastric cancer Microbiota testing Patients without gastric malignant disease according to data obtained in upper endoscopy Patients with dyspeptic symptoms Microbiota testing Patients with dyspeptic symptoms or other complains being referred for upper endoscopy (Chile) Average risk population Breath sampling for VOC detection Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer Average risk population Upper endoscopy Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer Average risk population Microbiota testing Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer Patients with dyspeptic symptoms Breath sampling for VOC detection Patients with dyspeptic symptoms or other complains being referred for upper endoscopy (Chile) Patients with dyspeptic symptoms Upper endoscopy Patients with dyspeptic symptoms or other complains being referred for upper endoscopy (Chile)
- 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)
Institute of Clinical and Preventive Medicine, University of Latvia
🇱🇻Riga, Latvia
A.C.Camargo Cancer Center
🇧🇷São Paulo, Brazil
Pontificia Universidad Catolica de Chile
🇨🇱Santiago, Chile
Centro Javeriano de OncologÃa, San Ignacio University Hospital
🇨🇴Bogotá, Colombia
National Cancer Institute of Ukraine
🇺🇦Kiev, Ukraine