Clinical trial Recruiting at 1 site Interventional Ages 18 to 100

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.

More Gastric Cancer trials

Quick facts

Study typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment1000 (estimated)
SponsorKU Leuven
Academic / other
Locations1 site (Leuven)
StatusRecruiting
StartedAugust 1, 2024
Main results expectedJuly 1, 2029
Study endsJuly 1, 2029
Registry record updatedFebruary 17, 2026
Trial IDNCT06346054 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.