Molecular Assessment for Gastro-Esophageal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breath analysis, Blood analysis.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer, Gastric Cancer, Barrett Esophagus. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test Breath analysis
Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath - Diagnostic test Blood analysis
Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood
Primary outcome measures
- Identification of the concentrations of oncometabolites [Time frame: year 1-2]
Secondary outcome measures (4)
- Assessment of incidence of early-stage cancer [Time frame: year 2-5]
- Assessment of incidence of therapy response [Time frame: year 2-5]
- Assessment of percentage change of therapy response [Time frame: year 2-5]
- Assessment of incidence of recurrence [Time frame: year 2-5]
Eligibility criteria
Inclusion criteria
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any breath or blood analysis
- >18 years old
- Barrett's esophagus or treatment naïve gastro-esophageal cancer stage I to IV
- Voluntary healthy controls
Exclusion criteria
- <18 years old
- Patient has history of:
- Active other cancer than gastro-esophageal cancer
- Prior cancer treated <3 years ago
- Hepatic dysfunction/liver failure (MELT >7)
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the study plan.
- Insufficient/unreliable quality of breath (e.g., breath flow) or plasma sample (e.g., haemolytic sample)
- Incarcerated individuals
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Belgium · 1 center
- University Hospitals Leuven — Leuven
Identifiers
NCT: NCT06346054 · s68669