Molecular Assessment for Gastro-Esophageal Cancer

Sponsor
KU Leuven
Study ID
NCT06346054
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Breath analysis — DIAGNOSTIC_TEST
    Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath
  • Blood analysis — DIAGNOSTIC_TEST
    Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood

Study Details

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.

Key Dates

First listed
Apr 3, 2024
Start date
Aug 1, 2024
Status verified
Feb 2026
Primary completion
Jul 1, 2029
Completion
Jul 1, 2029

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Gastro-esophageal cancer group
    Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification
  • Active Comparator: Barrett's esophagus group
    Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification
  • Active Comparator: Healthy controls
    Healthy controls providing a breath and blood sample for biomarker identification

Primary Outcome Measure

Identification of the concentrations of oncometabolites [ Time Frame: year 1-2 ]

Central Contacts

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