NCT06523374Recruiting
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
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 17 Jun 2024
- Start date
- 13 Aug 2025
- Primary completion date
- Apr 2026
- Lead sponsor
- University Hospital, Antwerp
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06523374
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 13 Aug 2025 to the primary completion date, Apr 2026
- 9 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
- Uncontrollable coagulation disorders
Other
- Esophageal varices
- WHO score \> 3
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Antwerp Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Sint-Augustinus Hospital (ZAS) Coordinator of this site? Confirm its status | Wilrijk | Belgium | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| CHU LILLE - Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| St. James's Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Recruiting |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.