Potential of non-invasive breath tests for preselecting individuals for invasive gastric cancer screening endoscopy.
Agne Krilaviciute, Christian Stock, Marcis Leja...
https://pubmed.ncbi.nlm.nih.gov/29528036/Actively Recruiting
Led by University of Latvia · Updated on 2021-07-26
5000
Participants Needed
5
Research Sites
208 weeks
Total Duration
Researchers are evaluating the potential use of breath volatile organic compounds VOCs to screen for gastric cancer. This study includes patients with confirmed gastric cancer or precancerous lesions, as well as individuals without lesions and those from the general population at average risk. It also explores how lifestyle factors, diet, smoking, and microbiota may affect VOC composition in the breath. Participants will undergo breath sampling using specialized sensor devices or gas chromatography coupled with mass spectroscopy GC-MS. Some gastric cancer patients will provide surgical tissue samples for VOC analysis. Other procedures include routine upper endoscopy with biopsies and collection of gastric and fecal samples to analyze the microbiota and its relationship with breath VOCs. Pepsinogen testing will also identify risk for gastric atrophy in some participants. During the study, researchers will identify characteristic VOC patterns for detecting gastric cancer and precancerous lesions over a 2 to 3-year period. They will assess the best-performing sensors and correlate VOCs with microbiota and metabolome data. Participants will be monitored with breath tests, endoscopies done when clinically indicated, and microbiota analysis. The study is conducted at clinical sites in Europe and Latin America and follows participants for up to three years after recruitment begins.
CONDITIONS
Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
M
Marcis Leja, MD, PhD
D
Daiga Santare, MD, PhD
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University of Latvia
Lead Sponsor
Technion, Israel Institute of Technology
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo breath sampling, upper endoscopy, and microbiota testing to detect volatile organic compounds and assess gastric health.
1 to 2 visits depending on clinical indications and subgroup assignments
Duration - Up to 3 years following initial assessment
Participants are monitored to identify characteristic VOC patterns and analyze gut microbiota in relation to breath VOCs over time.
Follow-up visits as needed for sample collection and assessment
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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Lead Sponsor
Technion, Israel Institute of Technology
Collaborating Sponsor