About this trial
This study is designed to perform a explorative search of the transcriptome to detect new circulating diagnostic sensitive and specific biomarkers in patients with Barrett's esophagus or esophageal adenocarcinoma.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Barrett's Esophagus with length > 3cm OR esophageal adenocarcinoma histologically proven
Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
Age over 18 years
No other concurrent malignant disease
Disqualifiers
Pregnancy or breast feeding
Active bacterial, viral or fungal infection
Parenchymal liver disease (any stage cirrhosis)
High risk of bleeding during biopsy (anticoagulants, esophageal varices)
Trial population
All patients diagnosed with Barrett oesophagus or esophageal adenocarcinoma who meet the eligibility criteria are candidates for inclusion in this study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Identification of plasma biomarkers (micro RNAs) for early detection of esophageal adenocarcinoma
Identification of micro RNAs in plasma and tissue of patients with (non-)dysplastic Barrett's esophagus and EAC that are differentially abundant, compared to healthy plasma (healthy volunteers) or healthy tissue (patient-matched healthy esophagus biopsies).
Identification of plasma biomarkers (messenger RNAs) for early detection of esophageal adenocarcinoma
Identification of messenger RNAs in plasma and tissue of patients with (non-)dysplastic Barrett's esophagus and EAC that are differentially abundant, compared to healthy plasma (healthy volunteers) or healthy tissue (patient-matched healthy esophagus biopsies).
Identification of biomarkers (messenger RNAs) for therapy response prediction
Identification of a set of messenger RNAs that change during treatment (using longitudinally collected plasma samples) and that separate responders from non-responders to neo-adjuvant radiochemotherapy.
Secondary outcomes
Development of a quantitative Polymerase Chain Reaction (qPCR) test for clinical use
After development and validation on an independent cohort, this test should be evaluated in a second external cohort
Sponsors and contacts
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University Hospital, Ghent
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator