Esophageal CancerMAGECNCT06346054
Molecular Assessment for Gastro-Esophageal Cancer
A study testing Breath analysis and Blood analysis in people with Esophageal Cancer and Gastric Cancer, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer, Barrett Esophagus
- What is being tested?
- Breath analysis and Blood analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2024to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Stijn Vanstraelen, MD, 16347863 ext. 0032, stijn.vanstraelen@kuleuven.be
About this study
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:
Read more
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
- Esophageal Cancer, Gastric Cancer, Barrett Esophagus
- Being tested
- Breath analysis, Blood analysis
- Keywords
- Oncometabolites, Early-stage cancer, Diagnostic testing, Screening
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Barrett Esophagus, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath analysisDiagnostic test
Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath
Blood analysisDiagnostic test
Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood
| Study group | Role | What they receive |
|---|---|---|
| Gastro-esophageal cancer group | Experimental | Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification Receives: Diagnostic Test: Breath analysis; Diagnostic Test: Blood analysis |
| Barrett's esophagus group | Active comparator | Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification Receives: Diagnostic Test: Breath analysis; Diagnostic Test: Blood analysis |
| Healthy controls | Active comparator | Healthy controls providing a breath and blood sample for biomarker identification Receives: Diagnostic Test: Breath analysis; Diagnostic Test: Blood analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the concentrations of oncometabolites
Identify the concentrations of cancer-related metabolites (oncometabolites) in the exhaled breath and blood compared to healthy controls
Measured: year 1-2
Secondary outcomes (4)
Assessment of incidence of early-stage cancer
Distinguish early-stage gastro-oesophageal cancer from Barrett's esophagus and healthy controls based on sensitivity, specificity and accuracy of the oncometabolite concentration
Measured: year 2-5
Assessment of incidence of therapy response
Predict and assess therapy response prior to surgery, based on sensitivity, specificity and accuracy of the oncometabolite concentration
Measured: year 2-5
Assessment of percentage change of therapy response
Assess changes in the concentrations of the oncometabolites related to treatment.
Measured: year 2-5
Assessment of incidence of recurrence
Predict and assess recurrence, based on sensitivity, specificity and accuracy of the oncometabolite concentration
Measured: year 2-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Aug 2024
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants with gastro-esophageal cancer, participants with Barrett's esophagus and Healthy controls will be monitored in parallel to identify oncometabolic biomarkers related to cancer
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stijn Vanstraelen, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Stijn Vanstraelen, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenPhilippe Nafteux, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346054
- Sponsor's protocol ID
- s68669
- Acronym
- MAGEC
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request with the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Assessment for Gastro-Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06346054
- Acronym / sponsor ID
- MAGEC / s68669
- Conditions
- Esophageal Cancer, Gastric Cancer, Barrett Esophagus
- Keywords
- Oncometabolites, Early-stage cancer, Diagnostic testing, Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants with gastro-esophageal cancer, participants with Barrett's esophagus and Healthy controls will be monitored in parallel to identify oncometabolic biomarkers related to cancer
| Arm | Type | Receives |
|---|---|---|
| Gastro-esophageal cancer group | Experimental | Diagnostic Test: Breath analysis, Diagnostic Test: Blood analysisParticipants with gastroesophageal cancer providing a breath and blood sample for biomarker identification |
| Barrett's esophagus group | Active comparator | Diagnostic Test: Breath analysis, Diagnostic Test: Blood analysisParticipants with Barrett's esophagus providing a breath and blood sample for biomarker identification |
| Healthy controls | Active comparator | Diagnostic Test: Breath analysis, Diagnostic Test: Blood analysisHealthy controls providing a breath and blood sample for biomarker identification |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- <18 years old
- Patient has history of:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath analysisDetection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath | Diagnostic test | Barrett's esophagus group, Gastro-esophageal cancer group, Healthy controls |
| Blood analysisDetection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood | Diagnostic test | Barrett's esophagus group, Gastro-esophageal cancer group, Healthy controls |
Primary outcome
Identification of the concentrations of oncometabolites
Time frame: year 1-2
Identify the concentrations of cancer-related metabolites (oncometabolites) in the exhaled breath and blood compared to healthy controls
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request with the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stijn Vanstraelen, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Philippe Nafteux, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath analysis and Blood analysis in people with Esophageal Cancer and Gastric Cancer, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stijn Vanstraelen, MD (16347863 ext. 0032, stijn.vanstraelen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the concentrations of oncometabolites (time frame: year 1-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.