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| ID | Type | Description | Link |
|---|---|---|---|
| 101136935 | Other Grant/Funding Number | European Commission (HORIZON EU) |
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Karolinska University Hospital | OTHER |
| Amsterdam UMC | OTHER |
| Radbound University Medical Center |
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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 early esophageal cancer, for which the participant will be evaluated by endoscopic imaging and biopsy.
Study procedures:
An intake consultation will be planned, wherein the eligibility criteria will be assessed, and participant characteristics will be collected.
A routine gastroscopy will be planned twice during which several minimally-invasive interventions will be performed: drawing a blood sample, brush cytology during the endoscopy (a brush is used to obtain cells from the surface of the esophagus) and obtaining biopsy samples (small pieces of tissue). Each participant will need to undergo all the interventions.
Patients will have to complete questionnaires at several time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale).
This study is a randomized trial, meaning the study participants will be divided into two groups by the computer. One group will be informed of their risk profile, established based on the genetic analyses. The other group will not be informed of their risk profile. All patients will be followed-up in a more intensive surveillance schedule compared to the standard of care, for study purposes.
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 (up to 4 tubes) will also be collected.
For this study, you will be contacted a total of four times. Once for a screening visit and twice for the sample collection described above. One last visite will be planned to discuss the risk profile, depending on the randomization group. After your initial treatment, you will be enrolled in a standard-of-care treatment schedule depending on your specific circumstances. This standard-of-care treatment schedule will coincide with the intensified surveillance schedule to detect recurrence earlier.
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 several time points during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants in the intervention arm will be informed by the investigator on their genetic risk profile. |
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| Control | No Intervention | Participants in the control arm will not be informed by the investigator on their genetic risk profile. Both the participant and the investigator are not aware of the genetic risk profile. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk profile disclosure | Other | Participants in the intervention arm will be informed by the investigator on their genetic risk profile. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease recurrence | Extraluminal recurrence (regional, distal) of cancer, endoluminal recurrence (metachronous, local) of cancer, endoluminal recurrence of dysplasia | From endoscopic resection up to three years after endoscopic eradication therapy |
| Cancer Worry Scale | Cancer Worry Scale (total score, 8-item version) after cessation of endoscopic eradication therapy (EET) | After cessation of endoscopic eradication therapy (EET), assessed up to 5 years after inclusion |
| Economic costs | Economic costs in euro for surveillance programme (including endoscopic procedures, biomarker analysis and materials) | From end of endoscopic eradication therapy until three years after endocsopic eradication therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Clonal diversity score | Clonal diversity score measurements based on DNA-FISH brush cytology samples before and after endoscopic resection | Between the baseline endoscopy (visit 1) and first endoscopy after endoscopic resection (visit 2) |
| Disease stage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Wyckmans, Resident Physician | Contact | +323 821 32 80 | martin.wyckmans@uza.be | |
| Luka Van der Veken, Master Biomedical Sciences | Contact | +3234368249 | luka.vanderveken@uza.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Edegem | Antwerpen | 2650 | Belgium | ||
| Sint-Augustinus Hospital (ZAS) |
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| Label | URL |
|---|---|
| Endeavor EU Website | View source |
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| UNKNOWN |
| University of Leipzig | OTHER |
| IRCCS Ospedale San Raffaele | OTHER |
| University of Dublin, Trinity College | OTHER |
| St. James's Hospital, Ireland | OTHER |
| Heinrich-Heine University, Duesseldorf | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Universitätsklinikum Leipzig | OTHER |
| GZA Ziekenhuizen Campus Sint-Augustinus | OTHER |
| AZ Delta | OTHER |
| University Hospital, Lille | OTHER |
| University Hospital, Ghent | OTHER |
RCT
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In this trial, there will be two arms:
Disease stage (histopathological disease stage of resection specimen, TNM-classification) based on EMR/ESD, EUS, PET-CT, pathology and cytology |
| From patient inclusion until three years after endoscopic eradication therapy |
| Missing data ePRO | Missing data events for ePRO and paper questionnaires | From start of inclusion until three years after endoscopic eradication |
| Caregiver's satisfaction | Caregiver's responses to questionnaire on application of biomarker-based health information | From start inclusion until three years after endoscopic eradication |
| Drop-out | Drop-out/delay events from allocated endoscopic surveillance, reasons for delays/drop-out | From start inclusion until three years after endoscopic eradication |
| Follow-up years | Total follow-up years: mean and average follow-up years per patient | From end of endoscopic eradication therapy until year three after endoscopic eradication |
| Cancer worry scale longitudinal | Cancer worry scale total score at predetermined, clinically relevant timepoints | From start of inclusion until year three after endscopic eradication therapy |
| EQ-5D-5L | EQ-5D-5L utility score and Visual Analogue Scale score at predetermined, clinically relevant timepoints | From start of inclusion until three years after endoscopic eradication |
| Quality adjusted life years (QALY) | QALY based on clinical endpoints, cancer worry scale results and EQ-5D-5L results | From start of inclusion until three years after endoscopic eradication |
| Endoscopy timepoint | Endoscopy timepoint at detected recurrence | From end of endoscopic resection until three years after endoscopic eradication therapy |
| Histopathological disease stage | Histopathological disease stage of detected recurrence | From end of endoscopic resection until three years after endoscopic eradication |
| Treatment stage recurrence | Treatment stage of detected recurrence (before / during / after RFA) | From endoscopic resection until three years after endocopic eradication |
| Mortality events | Overall and disease-specific mortality events | From endoscopic resection until three years after endoscopic eradication |
| Number of ablation sessions | Amount of ablation sessions needed to achieve CE-IM | From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion |
| Number of CE-IM patients | Number of patients that reach CE-IM | From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion |
| Number of RFA therapy-resistant patients | Number of RFA therapy-resistant patients defined as >50% residual Barrett Esophagus after first RFA session, or when residual BE is present after cessation of RFA therapy | From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion |
| Local recurrence | Local recurrence of adenocarcinoma (around the EMR/ESD scar site) | From endoscopic resection until three years after endoscopic eradication |
| Wilrijk |
| Antwerpen |
| 2610 |
| Belgium |
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| Ghent University Hospital (UZ Gent) | Ghent | Belgium | 9000 | Belgium |
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| AZ Delta | Roeselare | Belgium | 8800 | Belgium |
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| Rigshospitalet | Copenhagen | 2100 | Denmark |
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| CHU LILLE - Centre Hospitalier Universitaire de Lille | Lille | 59000 | France |
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| University Hospital Leipzig | Leipzig | Leipzig | 04103 | Germany |
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| St James's Hospital | Dublin | D08 NHY1 | Ireland |
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| IRCCS Ospedale San Raffaele | Milan | Milano | 20132 | Italy |
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| Karolinska University Hospital | Solna | SE-171 76 | Sweden |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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