Ex vivo emission of volatile organic compounds from gastric cancer and non-cancerous tissue.
Pawel Mochalski, Marcis Leja, Evita Gasenko...
https://pubmed.ncbi.nlm.nih.gov/29893713Actively Recruiting
Age: 18Years +
All Genders
ID04022109
Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
Led by University of Latvia · Updated on 2021-07-26
5000
Participants Needed
5
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University of Latvia
Lead Sponsor
T
Technion, Israel Institute of Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with verified gastric cancer
- Patients undergoing or having undergone upper endoscopy according to clinical indications
- Adults aged 40 to 64 years without alarm symptoms
- Motivation to participate in the study
- Physical status allowing breath sampling and other study procedures
- Signed informed consent
You will not qualify if you...
- Known active cancer other than gastric cancer
- Breathing difficulties or airway obstruction
- Unwillingness or inability to cooperate with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
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
Long-term Monitoring
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
Trial Site Locations
Total: 5 locations
1
A.C.Camargo Cancer Center
São Paulo, Brazil
Actively Recruiting
2
Pontificia Universidad Catolica de Chile
Santiago, Chile
Not Yet Recruiting
3
Centro Javeriano de Oncología, San Ignacio University Hospital
Bogotá, Colombia
Not Yet Recruiting
4
Institute of Clinical and Preventive Medicine, University of Latvia
Riga, Latvia, LV1050
Actively Recruiting
5
National Cancer Institute of Ukraine
Kiev, Ukraine
Actively Recruiting
Loading map...
Research Team
M
Marcis Leja, MD, PhD
D
Daiga Santare, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
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/29528036Detection of precancerous gastric lesions and gastric cancer through exhaled breath.
Haitham Amal, Marcis Leja, Konrads Funka...
https://pubmed.ncbi.nlm.nih.gov/25869737Detection of cancer through exhaled breath: a systematic review.
Agne Krilaviciute, Jonathan Alexander Heiss, Marcis Leja...
https://pubmed.ncbi.nlm.nih.gov/26440312Implementation of gastric cancer screening - the global experience.
Mārcis Leja, Weicheng You, M Constanza Camargo...
https://pubmed.ncbi.nlm.nih.gov/25439074Analysis of the effects of microbiome-related confounding factors on the reproducibility of the volatolomic test.
Marcis Leja, Haitham Amal, Ieva Lasina...
https://pubmed.ncbi.nlm.nih.gov/27341527