A Study of Barrett's Esophagus Patients to Investigate Quality of Life and Fear of Cancer, and Optimize a Risk Model Based on Biomarkers and New Technologies to Better Predict the Development of Cancer
NCT Number: NCT06523374
Acronym: Endeavor-1
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Barrett's Esophagus|Esophageal Adenocarcinoma
Interventions: PROCEDURE: Endoscopic brush cytology
Sponsor: University Hospital, Antwerp
Collaborators: Karolinska Institutet|Universal Diagnostics|Amsterdam UMC|Radboud University Medical Center|AZ Delta|Centre Hospitalier Universitaire de Liege|University of Leipzig|IRCCS Ospedale San Raffaele|Karolinska University Hospital|University of Dublin, Trinity College|Heinrich-Heine University, Duesseldorf|GZA Ziekenhuizen Campus Sint-Augustinus|University Hospital, Ghent|Rigshospitalet, Denmark|Universitätsklinikum Leipzig|St. James's Hospital, Ireland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-11
Completion Date: 2026-11
Locations: University Hospital Antwerp, Edegem, Antwerpen, 2650, Belgium|Sint-Augustinus Hospital (ZAS), Wilrijk, Antwerpen, 2610, Belgium|UZ Gent, Gent, 9000, Belgium|AZ Delta, Roeselare, 8800, Belgium|Rigshospitalet, Copenhagen, 2100, Denmark|CHU LILLE - Centre Hospitalier Universitaire de Lille, Lille, 59000, France|University Hospital Leipzig, Leipzig, 04103, Germany|St James's Hospital, Dublin, D08 NHY1, Ireland|IRCCS Ospedale San Raffaele, Milano, 20132, Italy|Karolinska University Hospital, Solna, SE-171 76, Sweden

Summary:
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 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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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, 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