Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
Healthy Volunteers
NCT06346054

Molecular Assessment for Gastro-Esophageal Cancer

Led by KU Leuven · Updated on 2026-02-17

1000

Participants Needed

1

Research Sites

256 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Molecular Assessment for Gastro-Esophageal Cancer

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary written informed consent obtained
  • Age over 18 years
  • Diagnosis of Barrett's esophagus or treatment-naive gastro-esophageal cancer stage I to IV
  • Voluntary healthy controls
Not Eligible

You will not qualify if you...

  • Under 18 years old
  • History of active cancer other than gastro-esophageal cancer
  • Prior cancer treated less than 3 years ago
  • Liver dysfunction or liver failure (MELT score over 7)
  • Any condition that may risk participant safety or study compliance as judged by the investigator
  • Poor quality breath or plasma samples (e.g., unreliable breath flow or hemolytic plasma sample)
  • Incarcerated individuals

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospitals Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

S

Stijn Vanstraelen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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