Molecular Assessment for Gastro-Esophageal Cancer
KU Leuven
1,000 participants
Aug 1, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this minimally invasive interventional study is to learn if oncometabolic biomarkers, detected in the exhaled breath and blood can identify early-stage gastro-oesophageal cancer in patient at risk for gastro-oesophageal cancer. The main questions this study aims to answer: Are oncometabolites proficient and reproducible enough to function as diagnostic biomarkers? Can these biomarkers identify early-stage gastro-esophageal cancer? Researchers will compare participants with gastro-oesophageal cancer to healthy controls and participants with Barrett's esophagus to detect meaningful differences between the groups. Participants will provide a breath and blood sample during their routine standard of care visits.
Eligibility
Inclusion Criteria4
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any breath or blood analysis
- \>18 years old
- Barrett's esophagus or treatment naïve gastro-esophageal cancer stage I to IV
- Voluntary healthy controls
Exclusion Criteria8
- \<18 years old
- Patient has history of:
- Active other cancer than gastro-esophageal cancer
- Prior cancer treated \<3 years ago
- Hepatic dysfunction/liver failure (MELT \>7)
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the study plan.
- Insufficient/unreliable quality of breath (e.g., breath flow) or plasma sample (e.g., haemolytic sample)
- Incarcerated individuals
Interventions
Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath
Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06346054