Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06523374

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

Led by University Hospital, Antwerp · Updated on 2026-02-24

50

Participants Needed

9

Research Sites

120 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Antwerp

Lead Sponsor

K

Karolinska Institutet

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with known Barrett's Esophagus undergoing endoscopy for possible treatment due to suspected early esophageal cancer
  • Able to understand the study and give informed consent
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Current known gastrointestinal cancer other than esophageal lesion
  • Severe heart or lung disease preventing endoscopic therapy under sedation
  • Presence of esophageal varices
  • Uncontrolled coagulation disorders
  • Receiving chemotherapy or immunotherapy or had chemotherapy within 6 weeks before endoscopy
  • Receiving radiotherapy in esophageal area or had chemotherapy within 6 months before endoscopy
  • WHO performance status greater than 3

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

University Hospital Antwerp

Edegem, Antwerpen, Belgium, 2650

Actively Recruiting

2

Sint-Augustinus Hospital (ZAS)

Wilrijk, Antwerpen, Belgium, 2610

Actively Recruiting

3

UZ Gent

Ghent, Belgium, 9000

Actively Recruiting

4

AZ Delta

Roeselare, Belgium, 8800

Actively Recruiting

5

Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

6

CHU LILLE - Centre Hospitalier Universitaire de Lille

Lille, France, 59000

Actively Recruiting

7

St James's Hospital

Dublin, Ireland, D08 NHY1

Actively Recruiting

8

IRCCS Ospedale San Raffaele

Milan, Milano, Italy, 20132

Actively Recruiting

9

Karolinska University Hospital

Solna, Sweden, SE-171 76

Actively Recruiting

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Research Team

T

Toon Mertens

CONTACT

L

Luka Van der Veken

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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