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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastro-esophageal cancer group | Experimental | Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification |
|
| Barrett's esophagus group | Active Comparator | Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification |
|
| Healthy controls | Active Comparator | Healthy controls providing a breath and blood sample for biomarker identification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath analysis | Diagnostic Test | Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of the concentrations of oncometabolites | Identify the concentrations of cancer-related metabolites (oncometabolites) in the exhaled breath and blood compared to healthy controls | year 1-2 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of incidence of early-stage cancer | Distinguish early-stage gastro-oesophageal cancer from Barrett's esophagus and healthy controls based on sensitivity, specificity and accuracy of the oncometabolite concentration | year 2-5 |
| Assessment of incidence of therapy response |
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Inclusion Criteria:
Exclusion Criteria:
<18 years old
Patient has history of:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stijn Vanstraelen, MD | Contact | 16347863 | 0032 | stijn.vanstraelen@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Stijn Vanstraelen, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Philippe Nafteux, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Recruiting | Leuven | 3000 | Belgium |
Data will be shared upon reasonable request with the principal investigator.
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D001471 | Barrett Esophagus |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D001944 | Breath Tests |
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
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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
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| Blood analysis | Diagnostic Test | Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood |
|
Predict and assess therapy response prior to surgery, based on sensitivity, specificity and accuracy of the oncometabolite concentration |
| year 2-5 |
| Assessment of percentage change of therapy response | Assess changes in the concentrations of the oncometabolites related to treatment. | year 2-5 |
| Assessment of incidence of recurrence | Predict and assess recurrence, based on sensitivity, specificity and accuracy of the oncometabolite concentration | year 2-5 |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011230 | Precancerous Conditions |