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Clinical Trials in Belgium / NCT06346054
Recruiting Not applicable

Molecular Assessment for Gastro-Esophageal Cancer

NCT06346054 · tracked via the Priya Life Science Belgium tracker
Sponsor
KU Leuven
Phase
Not applicable
Started
2024-08-01
Last updated
2026-02-17

Condition(s) studied

Esophageal CancerGastric CancerBarrett Esophagus

Investigational drug(s) / intervention(s)

Breath analysisBlood analysis

Breath analysis: Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath

Blood analysis: Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood

Study 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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospitals Leuven Leuven Belgium Recruiting

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Other trials for the same condition

A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors Recruiting
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A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06) Active, not recruiting
Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma Recruiting
Perioperative SDD to Prevent Infectious Complications After Esophagectomy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06346054 on ClinicalTrials.gov ↗ ← All trials in Belgium