Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2024-08-01
2029-07-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Gastro-esophageal cancer group
Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification
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
Barrett's esophagus group
Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification
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
Healthy controls
Healthy controls providing a breath and blood sample for biomarker identification
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. \>18 years old
3. Barrett's esophagus or treatment naïve gastro-esophageal cancer stage I to IV
4. Voluntary healthy controls
Exclusion Criteria
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
18 Years
100 Years
ALL
Yes
Sponsors
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KU Leuven
OTHER
Responsible Party
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Stijn Vanstraelen
Principal investigator
Principal Investigators
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Stijn Vanstraelen, MD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Philippe Nafteux, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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University Hospitals Leuven
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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s68669
Identifier Type: -
Identifier Source: org_study_id
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