RecruitingNCT04022109

Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach

Sponsor

University of Latvia

Enrollment

5,000 participants

Start Date

Nov 1, 2019

Study Type

OBSERVATIONAL

Conditions

Gastric Cancer Atrophic Gastritis Gastric Dysplasia H.Pylori Infection

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether breath analysis — detecting specific chemicals in exhaled breath called volatile organic compounds (VOCs) — can be used to screen for stomach (gastric) cancer in a non-invasive way. Researchers are developing a hybrid sensing approach to identify cancer-specific breath patterns. **You may be eligible if...** - You have confirmed gastric cancer, OR - You are undergoing upper endoscopy for clinical reasons, OR - You are an average-risk individual aged 40–64 without alarm symptoms (for healthy control group) - You are motivated to participate and physically able to provide a breath sample **You may NOT be eligible if...** - You have another active cancer besides gastric cancer - You have significant breathing problems or airway obstruction - You are unable or unwilling to cooperate with the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBreath 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

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