About this trial
This study serves, in part, to prepare for a future large cohort study. The goal of the study is:
1. The collection of various tissue samples (blood, biopsies and "esophageal brushes") and their analysis. 2. To set up standardized methods for different genetic analyses (DNA-FISH and so-called single cell sequencing) on the esophageal tissue samples. 3. Evaluating the quality of life of Barrett's Esophagus patients and the degree of fear of getting cancer.
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:
* 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 three time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale).
Eligibility criteria
Qualifiers
Patients with known BE undergoing endoscopy for possible treatment by EMR or ESD due to suspicion of early esophageal Barrett cancer
Capable of receiving informed consent and of giving permission
Age 18 and upward
Disqualifiers
Patients with current known malignancy of the gastrointestinal tract other than the esophageal lesion
Patients with severe co-morbidity that prohibits endoscopic therapy under sedation or conscious sedation (such as severe cardiac or pulmonary disease)
Esophageal varices
Uncontrollable coagulation disorders
Trial design
Treatments tested in this trial
- Endoscopic brush cytology
Treatment groups
Sponsors and collaborators
University Hospital, Antwerp
Lead sponsor
Karolinska Institutet
Collaborator
Universal Diagnostics
Collaborator
Amsterdam UMC
Collaborator
Radboud University Medical Center
Collaborator
AZ Delta
Collaborator
University of Leipzig
Collaborator
IRCCS Ospedale San Raffaele
Collaborator
Karolinska University Hospital
Collaborator
University of Dublin, Trinity College
Collaborator
Heinrich-Heine University, Duesseldorf
Collaborator
GZA Ziekenhuizen Campus Sint-Augustinus
Collaborator
University Hospital, Ghent
Collaborator
Rigshospitalet, Denmark
Collaborator
Universitätsklinikum Leipzig
Collaborator
St. James's Hospital, Ireland
Collaborator
University Hospital, Lille
Collaborator