Assessing breath and blood biomarkers for early detection of gastro-esophageal cancer
Molecular Assessment for Gastro-Esophageal Cancer
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06346054 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with Barrett's esophagus or treatment-naïve gastro-esophageal cancer stages I to IV.
Not a fit: Patients with a history of other active cancers, recent cancer treatment, or significant liver dysfunction may not benefit from this study.
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 performed: While the use of oncometabolites as diagnostic biomarkers is a novel approach, similar studies have shown promise in other cancer types.
Eligibility criteria
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 this trial is running
Leuven
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.