A Study of Barrett's Esophagus Patients: Optimization of a Risk Model to Better Predict the Development of Cancer Recurrence and the Effect of Risk Profile Disclosure on Patient Quality of Life and Fear of Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp

About this trial

The goal of the study is:

* The collection of various tissue samples (blood, biopsies and "esophageal brushes") and their analysis. * To test a risk model based on genetic analyses (DNA-FISH and so-called single cell sequencing) on esophageal tissue samples. * 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 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.

Eligibility criteria

Qualifiers

Patients with known BE undergoing endoscopy for possible treatment by EMR or ESD due to suspicion of T1 oesophageal 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 refusing randomization and corresponding follow-up intervals based on biomarker profile

Patients with severe co-morbidity that prohibits endoscopic therapy under sedation or conscious sedation (such as severe cardiac or pulmonary disease)

Esophageal varices

Trial design

Treatments tested in this trial

  • Risk profile disclosure

Treatment groups

266 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Antwerp

Lead sponsor

Karolinska Institutet

Collaborator

Karolinska University Hospital

Collaborator

Amsterdam UMC

Collaborator

Radbound University Medical Center

Collaborator

University of Leipzig

Collaborator

IRCCS Ospedale San Raffaele

Collaborator

University of Dublin, Trinity College

Collaborator

St. James's Hospital, Ireland

Collaborator

Heinrich-Heine University, Duesseldorf

Collaborator

Rigshospitalet, Denmark

Collaborator

Universitätsklinikum Leipzig

Collaborator

GZA Ziekenhuizen Campus Sint-Augustinus

Collaborator

AZ Delta

Collaborator

University Hospital, Lille

Collaborator

University Hospital, Ghent

Collaborator