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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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.
By developing new tools for risk-assessing of Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) in a population at risk, the investigators expect that diagnosis can be done in an earlier stage resulting in an improved 5-year survival. A proof-of-concept RNA profiling study will be done in 20 BE and EAC patients where 2 biomaterials (tissue and plasma) and 2 RNA biotopes (micro RNA and messenger RNA) will be compared. Previously validated methodology on small RNA and messenger RNA capture sequencing on both tissue and plasma will be used to obtain high-quality data. Differential expression analysis will be done on tissue and plasma sample data. Additional in-depth data-mining will be done, amongst other focusing on structural information encoded in the transcriptome and building a multifeature classifier. These findings will be validated in a large validation cohort, followed by development of a clinical-grade quantitative Polymerase Chain Reaction (qPCR) test, ready for testing in an independent cohort.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 years |
| 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). | 4 years |
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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All patients diagnosed with Barrett oesophagus or esophageal adenocarcinoma who meet the eligibility criteria are candidates for inclusion in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piet Pattyn, MD, PhD | Contact | +32 9 332 1295 | piet.pattyn@ugent.be | |
| Annouck Philippron, MD | Contact | +32 9 332 1531 | annouck.philippron@ugent.be |
| Name | Affiliation | Role |
|---|---|---|
| Piet Pattyn, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Ghent | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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plasma and tissue collection
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |