RecruitingNot ApplicableNCT06523374

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

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 in Preparation of a Randomized Controlled Trial to Determine the Feasibility of a Risk Stratification Model for Barrett Esophagus Patients Based on Brush Cytology, and to Test Novel High Throughput Methods for Assessing Biomarkers for Future Use


Sponsor

University Hospital, Antwerp

Enrollment

50 participants

Start Date

Aug 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating quality of life and fear of cancer in patients with Barrett's esophagus (a condition where the lining of the esophagus changes due to acid reflux and can lead to cancer), and testing new biomarkers and technologies to better predict cancer risk. **You may be eligible if...** - You are 18 or older - You have known Barrett's esophagus and are scheduled for an endoscopy procedure for treatment (EMR or ESD) because of suspected early esophageal cancer - You are able to provide informed consent **You may NOT be eligible if...** - You have another known active cancer in your digestive tract (other than the Barrett's lesion) - You have severe heart or lung disease that prevents endoscopy under sedation - You have esophageal varices (enlarged veins in the esophagus) - You have an uncontrollable bleeding disorder - You are currently receiving chemotherapy, immunotherapy, or received chemotherapy less than 6 weeks before the procedure - You had radiation to the esophagus area within the past 6 months - Your overall health status is very poor (WHO performance score above 3) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopic brush cytology

A total of four brush samples will be taken during the endoscopy. Other minimally invasive interventions during this study are standard of care.


Locations(9)

University Hospital Antwerp

Edegem, Antwerpen, Belgium

Sint-Augustinus Hospital (ZAS)

Wilrijk, Antwerpen, 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, Milano, Italy

Karolinska University Hospital

Solna, Sweden

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NCT06523374


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