NCT06346054 Molecular Assessment for Gastro-Esophageal Cancer
| NCT ID | NCT06346054 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KU Leuven |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2029-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2024-08-01 with a primary completion date of 2029-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Stijn Vanstraelen, MD
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT06346054 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Esophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06346054 currently recruiting?
Yes, NCT06346054 is actively recruiting participants. Contact the research team at stijn.vanstraelen@kuleuven.be for enrollment information.
Where is the NCT06346054 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06346054 clinical trial?
NCT06346054 is sponsored by KU Leuven. The principal investigator is Stijn Vanstraelen, MD at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 1,000 participants.
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