Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Latvia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known other active cancer
Ventilation problems, airway obstruction
Unwillingness or inability to co-operate
Trial population
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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Breath sampling for VOC detection
DeviceBreath 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
Surgery material collection for VOC headspace analysis
Procedure/SurgeryOnly for gastric cancer patients undergoing surgery (Group 1)
Upper endoscopy
Diagnostic testRoutine 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)
Microbiota testing
Diagnostic testFaecal and gastric contents and biopsy samples for microbiota testing
Treatment groups
5,000 Participants
are divided into 5 treatment groupsGroup A: Gastric cancer patients undergoing surgery4 interventions
Group B: Gastric cancer patients3 interventions
Group C: Control group patients without gastric cancer3 interventions
Group D: Average risk population3 interventions
Group E: Patients with dyspeptic symptoms3 interventions
Trial outcomes
Primary outcomes
1
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 recruitment2
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 recruitmentSecondary outcomes
1
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 recruitment2
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 recruitment3
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 recruitmentOther outcomes
1
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 recruitmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Latvia
Lead sponsor
Technion, Israel Institute of Technology
Collaborator
University of Ulm
Collaborator
Uppsala University
Collaborator
JLM Innovation GmbH
Collaborator
Universitaet Innsbruck
Collaborator
Hospital Universitario San Ignacio
Collaborator
Universidad de Pamplona
Collaborator
Pontificia Universidad Catolica de Chile
Collaborator
AC Camargo Cancer Center
Collaborator
National Cancer Institute of Ukraine
Collaborator
VTT Technical Research Centre of Finland
Collaborator
Source ClinicalTrials.gov