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| ID | Type | Description | Link |
|---|---|---|---|
| 101136935 | Other Grant/Funding Number | European Commission |
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Universal Diagnostics | INDUSTRY |
| Amsterdam UMC | OTHER |
| Radboud University Medical Center |
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This study serves, in part, to prepare for a future large cohort study. The goal of the study is:
Patients with a Barrett's Esophagus can participate in the study if they are minimally 18 years old, are capable of giving informed consent (fully understanding what the study entails before giving consent to participate), have Barrett Esophagus and are referred to one of the participating centers due to suspicion of high-grade dysplasia or early esophageal cancer, for which the participant will be evaluated by endoscopic imaging and biopsy.
Study procedures:
More specifically, you will have a standard endoscopy twice during which tissue samples will be taken from the esophagus to check for the severity of the disease. This is part of standard care. If you participate in the study, additional samples will be taken from the esophagus and also from the stomach (a total maximum of 10 samples of 1-2 mm). As a result, the endoscopic examination will take about 10-15 minutes longer than standard. Furthermore, in addition to the tissue samples, cells of the esophageal mucosa will be sampled (through 4 "esophageal brushes") and blood (4 tubes) will also be collected.
For this study, you will be contacted a total of three times. Once for a screening visit and twice for the sample collection described above. The screening and sample collection will take place during the already scheduled treatments and consultations. Afterwards, patient outcomes will be documented for the study until a maximum of 5 years after inclusion. This documentation will take place during the routine follow up so does not require any additional visits for the patients. Additionally you will be asked to complete two short questionnaires on your mobile phone at three time points during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic brush cytology | Other | Each participant will receive all interventions. A routine endoscopy will be planned during which several minimally invasive interventions will be performed: drawing a blood sample (standard of care), brush cytology (not standard of care) and biopsies (standard of care) during the endoscopy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic brush cytology | Procedure | A total of four brush samples will be taken during the endoscopy. Other minimally invasive interventions during this study are standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of brush, biopsy and blood samples obtained from different sites for analysis by HTP technologies | We will determine the success rate of obtaining material from different sites for analysis by high throughput technologies (Next Generation Sequencing) of the brush, biopsy or blood samples. A rate of analysable cells of at least 80% of the specimens will be regarded as successful. | 6-12 months |
| Success rate of DNA-FISH analyses on the brush cytology samples | Our second primary outcome measure for this pilot study is successful DNA-FISH analysis (successful = at least 50 cells that can be analyzed in at least 80% of participants) on the brush cytology samples for defining the final risk model that will be applied in the randomized controlled trial following the pilot study. | 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of a DNA-FISH based risk model | The first secondary outcome is the accuracy of a DNA-FISH based risk model to distinguish low risk from high-risk early Barrett cancers. This will be assessed by endoscopic imaging and histo-pathological outcomes. | 6-24 months |
| Correlation of a DNA-FISH based risk model |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toon Mertens | Contact | +3234368281 | Toon.mertens@uza.be | |
| Luka Van der Veken | Contact | +3234368249 | luka.vanderveken@uza.be |
| Name | Affiliation | Role |
|---|---|---|
| Sheila Krishnadath | Universitair Ziekenhuis Antwerpen (UZA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Recruiting | Edegem | Antwerpen | 2650 | Belgium |
| OTHER |
| AZ Delta | OTHER |
| University of Leipzig | OTHER |
| IRCCS Ospedale San Raffaele | OTHER |
| Karolinska University Hospital | OTHER |
| University of Dublin, Trinity College | OTHER |
| Heinrich-Heine University, Duesseldorf | OTHER |
| GZA Ziekenhuizen Campus Sint-Augustinus | OTHER |
| University Hospital, Ghent | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Universitätsklinikum Leipzig | OTHER |
| St. James's Hospital, Ireland | OTHER |
| University Hospital, Lille | OTHER |
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The correlation of a DNA-FISH based risk model to distinguish low risk from high-risk early Barrett cancers with results obtained from Next Generation Sequencing. |
| 6-24 months |
| Standard operating procedures for specimen collection | A standard operating procedure describing the best method for obtaining brush cytology specimens and for obtaining the right tissue specimens via endoscopy will be created. The best method will be determined by the quality and number of analysable cells. | 6-24 months |
| Standard operating procedures for logistical procedures | A standard operating procedure (SOP) for the logistics for shipment, redistribution and storage of patient material and data of the different participating sites will be created based on the course of this pilot study. Interim logistical problems will be spontaneously reported by all sites and resolved with the central team. The final solutions ("best method") will be described in the SOP. | 6-24 months |
| Successful participation and answering of questionnaires | The participation and answering of the quality of life questionnaires and anxiety level questionnaires of at least 70% of the patients will be seen as successful. | 6-24 months |
| Sint-Augustinus Hospital (ZAS) | Recruiting | Wilrijk | Antwerpen | 2610 | Belgium |
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| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
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| AZ Delta | Recruiting | Roeselare | 8800 | Belgium |
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| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| CHU LILLE - Centre Hospitalier Universitaire de Lille | Recruiting | Lille | 59000 | France |
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| St James's Hospital | Recruiting | Dublin | D08 NHY1 | Ireland |
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| IRCCS Ospedale San Raffaele | Recruiting | Milan | Milano | 20132 | Italy |
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| Karolinska University Hospital | Recruiting | Solna | SE-171 76 | Sweden |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| C562730 | Adenocarcinoma Of Esophagus |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
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