Actively Recruiting
Endoscopic Brush Cytology and Single Cell Clonal Dynamics of Early Esophageal Adenocarcinoma for Defining Cost Effective Surveillance Strategies and Prediction of Cancer Recurrence: Prospective Pilot Cohort Study to Develop a Risk Stratification Model for Barrett Esophagus Patients
Led by University Hospital, Antwerp · Updated on 2026-02-24
50
Participants Needed
9
Research Sites
87 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
Researchers are studying Barrett's Esophagus and early esophageal cancer to prepare for a larger future study. The study aims to collect tissue samples from the esophagus and blood to analyze genetic markers using new high-throughput methods. It also evaluates the quality of life and fear of cancer in patients with Barrett's Esophagus, focusing on those referred for suspicion of high-grade dysplasia or early cancer. Participants will undergo two routine endoscopies during which standard biopsies and blood samples will be taken, along with additional samples specifically for the study. These include cells collected by brush cytology from the esophagus and up to ten tissue samples from the esophagus and stomach. The extra procedures extend the endoscopy by about 10-15 minutes. The study involves three contacts: one screening visit and two sample collections during scheduled care. During the study, participants will complete questionnaires on quality of life and cancer worry at three different times using their mobile phones. Researchers will monitor the success of sample collection and genetic analysis over 6 to 24 months. Patient outcomes will be followed for up to five years through routine care visits without requiring extra visits. The study is sponsored by University Hospital, Antwerp.
CONDITIONS
Brief 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 suspicion of early esophageal Barrett cancer
- Able to understand and give informed consent
- Age 18 years and older
You will not qualify if you...
- Current known gastrointestinal cancer other than the esophageal lesion
- Severe health problems preventing sedation during endoscopy (e.g., severe heart or lung disease)
- Presence of esophageal varices
- Uncontrolled bleeding disorders
- Undergoing chemotherapy or immunotherapy, or received chemotherapy less than 6 weeks before endoscopy
- Undergoing radiotherapy in the esophageal area, or received radiotherapy less than 6 months before endoscopy
- WHO performance score greater than 3
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants undergo two standard endoscopies during which additional tissue, cell, and blood samples are collected for analysis.
2 visits (in-person) during routine endoscopies
Duration - Up to 5 years
Participants are observed during routine follow-up visits for up to 5 years to document outcomes and complete questionnaires at specific time points.
Follow-up during routine care with no additional visits; questionnaires completed remotely
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
L
Luka Van der Veken
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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