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

Summary

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.

Conditions

• Barrett Esophagus
• Barrett Esophagus Adenocarcinoma
• Adenocarcinoma - GEJ
• Gastroenterology
• Gastroenterological Cancer

Interventions

OTHER

Risk profile disclosure

Participants in the intervention arm will be informed by the investigator on their genetic risk profile.

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Amsterdam UMC

  collaborator OTHER

• Radbound University Medical Center

  collaborator UNKNOWN

• University of Leipzig

  collaborator OTHER

• IRCCS Ospedale San Raffaele

  collaborator OTHER

• University of Dublin, Trinity College

  collaborator OTHER

• St. James's Hospital, Ireland

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Universitätsklinikum Leipzig

  collaborator OTHER

• GZA Ziekenhuizen Campus Sint-Augustinus

  collaborator OTHER

• AZ Delta

  collaborator OTHER

• Lille University Hospital

  collaborator UNKNOWN

• University Hospital, Ghent

  collaborator OTHER

• University Hospital, Antwerp

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2030-12-31

Completion

2030-12-31

Countries

• Belgium
• Denmark
• France
• Germany
• Ireland
• Italy
• Sweden

Study Locations