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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

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Antwerp
NCT06523374 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with known BE undergoing endoscopy for possible treatment by EMR or ESD due to suspicion of early esophageal Barrett cancer * Capable of receiving informed consent and of giving permission * Age 18 and upward Exclusion Criteria: * Patients with current known malignancy of the gastrointestinal tract other than the esophageal lesion * Patients with severe co-morbidity that prohibits endoscopic therapy under sedation or conscious sedation (such as severe cardiac or pulmonary disease) * Esophageal varices * Uncontrollable coagulation disorders * Undergoing chemotherapy or immunotherapy or received chemotherapy \< 6 weeks prior to endoscopy * Undergoing radiotherapy within the esophageal region or received chemotherapy \< 6 months prior to endoscopy * WHO score \> 3
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What it tests

  • Endoscopic brush cytology
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Where

9 sites
University Hospital Antwerp
Edegem, Belgium
Sint-Augustinus Hospital (ZAS)
Wilrijk, Belgium
UZ Gent
Ghent, Belgium
AZ Delta
Roeselare, Belgium
Rigshospitalet
Copenhagen, Denmark
CHU LILLE - Centre Hospitalier Universitaire de Lille
Lille, France
St James's Hospital
Dublin, Ireland
IRCCS Ospedale San Raffaele
Milan, Italy

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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