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

Recruiting now · Not applicable

Conditions studied: Barrett's Esophagus, Esophageal Adenocarcinoma

In brief

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).

Key facts

Study ID

NCT06523374

Run by

University Hospital, Antwerp

People needed

50

Starts

2025-08-13

Expected to finish

2027-12-01

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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