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

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 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).

Conditions

• Barrett's Esophagus
• Esophageal Adenocarcinoma

Interventions

PROCEDURE

Endoscopic brush cytology

A total of four brush samples will be taken during the endoscopy. Other minimally invasive interventions during this study are standard of care.

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Universal Diagnostics

  collaborator INDUSTRY

• Amsterdam UMC

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• AZ Delta

  collaborator OTHER

• University of Leipzig

  collaborator OTHER

• IRCCS Ospedale San Raffaele

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• University of Dublin, Trinity College

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• GZA Ziekenhuizen Campus Sint-Augustinus

  collaborator OTHER

• University Hospital, Ghent

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Universitätsklinikum Leipzig

  collaborator OTHER

• St. James's Hospital, Ireland

  collaborator OTHER

• Lille University Hospital

  collaborator UNKNOWN

• University Hospital, Antwerp

  lead OTHER

Principal Investigators

• Sheila Krishnadath · Universitair Ziekenhuis Antwerpen (UZA)

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-13

Primary Completion

2026-04-30

Completion

2027-12-31

Countries

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

Study Locations