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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp

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

50 Participants
are divided into 1 treatment group

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