Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06523374

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

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 suspicion of early esophageal Barrett cancer
  • Able to understand and give informed consent
  • Age 18 years and older
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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