Esophageal Cancer, Gastric Cancer, Barrett Esophagus
Conditions
Keywords
Oncometabolites, Early-stage cancer, Diagnostic testing, Screening
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.
Interventions
DIAGNOSTIC_TESTBreath analysis
Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath
DIAGNOSTIC_TESTBlood analysis
Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood
Sponsors
KU Leuven
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participants with gastro-esophageal cancer, participants with Barrett's esophagus and Healthy controls will be monitored in parallel to identify oncometabolic biomarkers related to cancer
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of the concentrations of oncometabolites | year 1-2 | Identify the concentrations of cancer-related metabolites (oncometabolites) in the exhaled breath and blood compared to healthy controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of incidence of early-stage cancer | year 2-5 | Distinguish early-stage gastro-oesophageal cancer from Barrett's esophagus and healthy controls based on sensitivity, specificity and accuracy of the oncometabolite concentration |
| Assessment of incidence of therapy response | year 2-5 | Predict and assess therapy response prior to surgery, based on sensitivity, specificity and accuracy of the oncometabolite concentration |
| Assessment of percentage change of therapy response | year 2-5 | Assess changes in the concentrations of the oncometabolites related to treatment. |
| Assessment of incidence of recurrence | year 2-5 | Predict and assess recurrence, based on sensitivity, specificity and accuracy of the oncometabolite concentration |
Countries
Belgium
Contacts
CONTACTStijn Vanstraelen, MD
PRINCIPAL_INVESTIGATORStijn Vanstraelen, MD
Universitaire Ziekenhuizen KU Leuven
PRINCIPAL_INVESTIGATORPhilippe Nafteux, MD, PhD
Universitaire Ziekenhuizen KU Leuven
Outcome results
None listed