An observational study in Gastric Cancer, Atrophic Gastritis and Gastric Dysplasia, sponsored by University of Latvia. Recruiting at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-26.
Sponsored by University of Latvia · Observational
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.
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.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 278 across 790 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →University of Latvia is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cancer patient population will be recruited in the major specialized cancer centres in Europe (Latvia, Ukraine) and Latin America (Colombia, Chile, Brazil) Control group patients will be recruited in the major specialized endoscopy centres in Europe (Latvia, Ukraine) and Latin America (Colombia, Chile, Brazil), most frequently - the same institutions as for cancer patient recruitment General population group (40-64 years) will be predominantly recruited in Latvia from the general population Symptomatic patient validation cohort (Group 5) will be predominantly recruited in Chile from the endoscopy referrals
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management
Device: Breath sampling for VOC detection · Procedure: Surgery material collection for VOC headspace analysis · Diagnostic Test: Upper endoscopy · Diagnostic Test: Microbiota testing
Patients with histologically confirmed gastric cancer (adenocarcinoma)
Device: Breath sampling for VOC detection · Diagnostic Test: Upper endoscopy · Diagnostic Test: Microbiota testing
Patients without gastric malignant disease according to data obtained in upper endoscopy
Device: Breath sampling for VOC detection · Diagnostic Test: Upper endoscopy · Diagnostic Test: Microbiota testing
Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer
Device: Breath sampling for VOC detection · Diagnostic Test: Upper endoscopy · Diagnostic Test: Microbiota testing
Patients with dyspeptic symptoms or other complains being referred for upper endoscopy (Chile)
Device: Breath sampling for VOC detection · Diagnostic Test: Upper endoscopy · Diagnostic Test: Microbiota testing
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
Also known as: Serum, plasma sampling for group description and stratification
Only for gastric cancer patients undergoing surgery (Group 1)
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)
Also known as: Histological and microbial evaluation of biopsy samples and gastric content
Faecal and gastric contents and biopsy samples for microbiota testing
Characteristic VOC pattern identification for gastric cancer detection
The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected
Time frame: 2 years following initiation of patient recruitment
Specific chemistry identification in the exhaled breath
Identification of specific chemistries (GC-MS analysis) originating from gastric cancer
Time frame: 2 years following initiation of patient recruitment
Characteristic VOC pattern identification for gastric precancerous lesion detection
The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected
Time frame: 2.5 years following initiation of patient recruitment
Identification of the best-performing sensors
Comparative analysis between the performance of different sensor performance in target disease identification
Time frame: 3 years following initiation of patient recruitment
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
Time frame: 3 years following initiation of patient recruitment
Confounding factor analysis
The role of confounding factors will be addressed to address their role in VOC emission
Time frame: 3 years following initiation of patient recruitment
Plan to share: No
Started Nov 2019 (actual). Primary completion is estimated for Dec 2022, 37 months after the start.
Of 322 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 171. This study's planned 37 months is below that.
Counting every sponsor, half of 364 studies reached it within 54 months; a quarter within 29 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Latvia