• 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

  NCT06523374

  RecruitingInterventionalNot ApplicableUpdated Feb 24, 2026
• Early Detection of Barrett's Esophagus

  NCT00081354

  CompletedObservationalUpdated May 22, 2020
• Stratifying Risk in Barrett's Esophagus: A Pilot Study for Biomarker-based Patient Management

  NCT02075905

  CompletedObservationalUpdated Dec 20, 2016
• Esophageal Cancer Risk Registry

  NCT00260585

  RecruitingObservationalUpdated Apr 14, 2026
• APE-Study: Ablation of Barrett's Mucosa vs. Surveillance Without Ablation in Patients Cured From Barrett's Cancer Combined With Randomization of Esomeprazole vs. Placebo for Symptomatic Reflux Control After Successful Barrett's Ablation

  NCT00546065

  TerminatedInterventionalNot ApplicableUpdated Nov 29, 2011
• Barrett&Apos;s Intervention for Dysplasia by Endoscopy

  NCT01733719

  CompletedInterventionalNot ApplicableUpdated Mar 11, 2016

ClinicalTrials.gov ID

NCT07455422

Lead Sponsor

University Hospital, AntwerpOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

266Estimated

Last Update Posted

Mar 6, 2026Actual

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2030Estimated

Official Title

A Randomized Controlled Trial Using Endoscopic Brush Cytology and Single Cell Clonal Dynamics of Early ESOPHAGEAL ADENOCARCINOMA for Assessing Effects on Quality of Life, Cancer Worry and Defining Cost-Effective Surveillance Strategies

Brief 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.

Detailed Description

More specifically, you will have a standard endoscopy twice during which tissue samples will be taken from the esophagus to check for the severity of the disease. This is part of standard care. If you participate in the study, additional samples will be taken from the esophagus and also from the stomach (a total maximum of 10 samples of 1-2 mm). As a result, the endoscopic examination will take about 10-15 minutes longer than standard. Furthermore, in addition to the tissue samples, cells of the esophageal mucosa will be sampled (through 4 "esophageal brushes") and blood (up to 4 tubes) will also be collected.

For this study, you will be contacted a total of four times. Once for a screening visit and twice for the sample collection described above. One last visite will be planned to discuss the risk profile, depending on the randomization group. After your initial treatment, you will be enrolled in a standard-of-care treatment schedule depending on your specific circumstances. This standard-of-care treatment schedule will coincide with the intensified surveillance schedule to detect recurrence earlier.

Patient outcomes will be documented for the study until a maximum of 5 years after inclusion. This documentation will take place during the routine follow up so does not require any additional visits for the patients. Additionally you will be asked to complete two short questionnaires on your mobile phone at several time points during the study.

• Barrett Esophagus
• Barrett Esophagus Adenocarcinoma
• Adenocarcinoma - GEJ
• Gastroenterology
• Gastroenterological Cancer

• Risk profile disclosure

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Diagnostic

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

University Hospital, AntwerpOTHER

Collaborators

Karolinska InstitutetOTHER

Karolinska University HospitalOTHER

Amsterdam UMCOTHER

Radbound University Medical CenterUNKNOWN

University of LeipzigOTHER

IRCCS Ospedale San RaffaeleOTHER

University of Dublin, Trinity CollegeOTHER

St. James's Hospital, IrelandOTHER

Heinrich-Heine University, DuesseldorfOTHER

Rigshospitalet, DenmarkOTHER

Universitätsklinikum LeipzigOTHER

GZA Ziekenhuizen Campus Sint-AugustinusOTHER

AZ DeltaOTHER

University Hospital, LilleOTHER

University Hospital, GhentOTHER

david.tate@uzgent.be0032 9 332 23 00

dominiek.dewulf@azdelta.be+32 51 23 72 15

michael.patrick.achiam.01@regionh.dk+45 35 45 04 41

rene.thieme@medizin.uni-leipzig.de+49 341 97 20809

OSULLIJ4@tcd.ie+353 1 8962149

Ungaro.Federica@hsr.it+39 0226437864

fredrik.klevebro@regionstockholm.se+46-8-585 800 00