Molecular Assessment for Gastro-Esophageal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Breath analysis
- Conditions
- Esophageal Cancer
- Sponsor
- KU Leuven
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Identification of the concentrations of oncometabolites
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Stijn Vanstraelen
Principal investigator
Universitaire Ziekenhuizen KU Leuven
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\<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
Arms & Interventions
Gastro-esophageal cancer group
Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification
Intervention: Breath analysis
Gastro-esophageal cancer group
Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification
Intervention: Blood analysis
Barrett's esophagus group
Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification
Intervention: Breath analysis
Barrett's esophagus group
Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification
Intervention: Blood analysis
Healthy controls
Healthy controls providing a breath and blood sample for biomarker identification
Intervention: Breath analysis
Healthy controls
Healthy controls providing a breath and blood sample for biomarker identification
Intervention: Blood analysis
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Assessment of incidence of recurrence(year 2-5)
- Assessment of incidence of early-stage cancer(year 2-5)
- Assessment of incidence of therapy response(year 2-5)
- Assessment of percentage change of therapy response(year 2-5)