Atrophic Gastritis, Gastric Cancer, Gastric Dysplasia, H.Pylori Infection
Conditions
Keywords
Volatile organic compounds, Breath testing, Gastric cancer, Atrophic gastritis, Precancerous lesions, Screening, Nanosensor technology, GC-MS
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.
Interventions
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
PROCEDURESurgery material collection for VOC headspace analysis
Only for gastric cancer patients undergoing surgery (Group 1)
DIAGNOSTIC_TESTUpper 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_TESTMicrobiota testing
Faecal and gastric contents and biopsy samples for microbiota testing
Sponsors
Technion, Israel Institute of Technology
University of Ulm
Uppsala University
JLM Innovation GmbH
Universitaet Innsbruck
Hospital Universitario San Ignacio
Universidad de Pamplona
Pontificia Universidad Catolica de Chile
AC Camargo Cancer Center
National Cancer Institute of Ukraine
VTT Technical Research Centre of Finland
University of Latvia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Confounding factor analysis | 3 years following initiation of patient recruitment | The role of confounding factors will be addressed to address their role in VOC emission |
Countries
Brazil, Chile, Colombia, Latvia, Ukraine
Contacts
Primary ContactMarcis Leja, MD, PhD
Backup ContactDaiga Santare, MD, PhD
Outcome results
None listed