Not Yet RecruitingNot Applicable

A Study of Barrett's Esophagus Patients: Optimization of a Risk Model to Better Predict the Development of Cancer Recurrence and the Effect of Risk Profile Disclosure on Patient Quality of Life and Fear of Cancer

Belgium, Denmark, France266 participantsStarted 2026-06-01

Plain-language summary

The goal of the study is: * The collection of various tissue samples (blood, biopsies and "esophageal brushes") and their analysis. * To test a risk model based on genetic analyses (DNA-FISH and so-called single cell sequencing) on esophageal tissue samples. * 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 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 several time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale). This study is a randomized trial, meaning the study participants will be divided into two groups by the computer. One group will be informed of their risk profile, established based on the genetic analyses. The other group will not be informed of their risk profile. All patients will be followed-up in a more intensive surveillance schedule compared to the standard of care, for study purposes.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with known BE undergoing endoscopy for possible treatment by EMR or ESD due to suspicion of T1 oesophageal 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 refusing randomization and corresponding follow-up intervals based on biomarker profile * 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/planned chemotherapy or immunotherapy or received chemotherapy \< 6 months prior to endoscopy * Undergoing/planned radiotherapy within the esophageal region or received radiotherapy \< 6 months prior to endoscopy * WHO score \>3

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Disease recurrence

Timeframe: From endoscopic resection up to three years after endoscopic eradication therapy

Cancer Worry Scale

Timeframe: After cessation of endoscopic eradication therapy (EET), assessed up to 5 years after inclusion

Economic costs

Timeframe: From end of endoscopic eradication therapy until three years after endocsopic eradication therapy

Trial details

NCT IDNCT07455422

SponsorUniversity Hospital, Antwerp

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-31

Contact for this trial

Martin Wyckmans, Resident Physician

+323 821 32 80 martin.wyckmans@uza.be

View on ClinicalTrials.gov More Barrett Esophagus trials