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Molecular Assessment for Gastro-Esophageal Cancer

RECRUITINGN/ASponsored by KU Leuven
Actively Recruiting
PhaseN/A
SponsorKU Leuven
Started2024-08-01
Est. completion2029-07-01
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted

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

Age: 18 Years – 100 YearsHealthy 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

Conditions4

Barrett EsophagusCancerEsophageal CancerGastric Cancer

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