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
University Hospital, Antwerp
50 participants
Aug 13, 2025
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
Inclusion Criteria3
- 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 Criteria7
- 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
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06523374