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).
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
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
Single group
Endoscopic brush cytology
Procedure/SurgeryA total of four brush samples will be taken during the endoscopy. Other minimally invasive interventions during this study are standard of care.
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.
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.
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.
Correlation of a DNA-FISH based risk model
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.
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.
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.
Click on the lead sponsor to view all of their trials.
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
