Assessing breath and blood biomarkers for early detection of gastro-esophageal cancer
Official title: Molecular Assessment for Gastro-Esophageal Cancer
Run by KU Leuven · NCT06346054 · Data updated 2026-11-12
This study is testing if breath and blood samples can help find early signs of gastro-esophageal cancer in people who are at risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | July 1, 2029 |
| Study ends | July 1, 2029 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT06346054 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with Barrett's esophagus or treatment-naïve gastro-esophageal cancer stages I to IV.
✕Probably not a fit
Patients with a history of other active cancers, recent cancer treatment, or significant liver dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study aims to evaluate the effectiveness of oncometabolic biomarkers found in exhaled breath and blood samples for identifying early-stage gastro-esophageal cancer in at-risk patients. Participants, including those with Barrett's esophagus and treatment-naïve gastro-esophageal cancer, will provide breath and blood samples during routine care visits. The study will compare these samples to those from healthy controls to determine the proficiency and reproducibility of the biomarkers as diagnostic tools.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of gastro-esophageal cancer, improving patient outcomes.
How similar studies have gone: While the use of oncometabolites as diagnostic biomarkers is a novel approach, similar studies have shown promise in other cancer types.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any breath or blood analysis 2. \>18 years old 3. Barrett's esophagus or treatment naïve gastro-esophageal cancer stage I to IV 4. Voluntary healthy controls Exclusion Criteria: 1. \<18 years old 2. Patient has history of: 1. Active other cancer than gastro-esophageal cancer 2. Prior cancer treated \<3 years ago 3. Hepatic dysfunction/liver failure (MELT \>7) 3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the study plan. 4. Insufficient/unreliable quality of breath (e.g., breath flow) or plasma sample (e.g., haemolytic sample) 5. Incarcerated individuals
Where it's running
-
University Hospitals Leuven
Leuven, Belgium Recruiting
Study contacts
- Principal investigator: Stijn Vanstraelen, MD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Stijn Vanstraelen, MD
- Email: stijn.vanstraelen@kuleuven.be
- Phone: 16347863
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.