Actively Recruiting
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
Eligibility Criteria
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
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
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
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here