Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
NCT04022109 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000
Last updated 2021-07-26
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.
Conditions
- Gastric Cancer
- Atrophic Gastritis
- Gastric Dysplasia
- H.Pylori Infection
Interventions
- DEVICE
-
Breath sampling for VOC detection
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
- PROCEDURE
-
Surgery material collection for VOC headspace analysis
Only for gastric cancer patients undergoing surgery (Group 1)
- DIAGNOSTIC_TEST
-
Upper 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_TEST
-
Microbiota testing
Faecal and gastric contents and biopsy samples for microbiota testing
Sponsors & Collaborators
-
Technion, Israel Institute of Technology
collaborator OTHER -
University of Ulm
collaborator OTHER -
Uppsala University
collaborator OTHER -
JLM Innovation GmbH
collaborator UNKNOWN -
Universitaet Innsbruck
collaborator OTHER -
Hospital Universitario San Ignacio
collaborator OTHER -
Universidad de Pamplona
collaborator OTHER -
Pontificia Universidad Catolica de Chile
collaborator OTHER -
AC Camargo Cancer Center
collaborator OTHER -
National Cancer Institute of Ukraine
collaborator OTHER -
VTT Technical Research Centre of Finland
collaborator OTHER -
University of Latvia
lead OTHER
Principal Investigators
-
Hossam Haick, PhD · TECHNION, Israel Institute for Technology
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-01
- Primary Completion
- 2022-12-31
- Completion
- 2026-12-31
Countries
- Brazil
- Chile
- Colombia
- Latvia
- Ukraine
Study Locations
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