• 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

  NCT07455422

  Not yet recruitingInterventionalNot ApplicableUpdated Mar 6, 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
• Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus

  NCT00844077

  CompletedObservationalUpdated Dec 7, 2011
• Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma

  NCT00288119

  RecruitingObservationalUpdated Aug 10, 2026
• University of North Carolina (UNC) Barrett's Esophagus and Esophageal Cancer Biorepository

  NCT02427269

  Enrolling by invitationObservationalUpdated Jun 24, 2026

ClinicalTrials.gov ID

NCT06523374

Lead Sponsor

University Hospital, AntwerpOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

50Estimated

Last Update Posted

Feb 24, 2026Actual

Start Date

Aug 13, 2025Actual

Primary Completion Date

Apr 2026Estimated

Completion Date

Dec 2027Estimated

Official Title

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

Brief 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).

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 (4 tubes) will also be collected.

For this study, you will be contacted a total of three times. Once for a screening visit and twice for the sample collection described above. The screening and sample collection will take place during the already scheduled treatments and consultations. Afterwards, 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 three time points during the study.

• Barrett's Esophagus
• Esophageal Adenocarcinoma

• Endoscopic brush cytology

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 early esophageal 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 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

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, AntwerpOTHER

Collaborators

Karolinska InstitutetOTHER

Universal DiagnosticsINDUSTRY

Amsterdam UMCOTHER

Radboud University Medical CenterOTHER

AZ DeltaOTHER

University of LeipzigOTHER

IRCCS Ospedale San RaffaeleOTHER

Karolinska University HospitalOTHER

University of Dublin, Trinity CollegeOTHER

Heinrich-Heine University, DuesseldorfOTHER

GZA Ziekenhuizen Campus Sint-AugustinusOTHER

University Hospital, GhentOTHER

Rigshospitalet, DenmarkOTHER

Universitätsklinikum LeipzigOTHER

St. James's Hospital, IrelandOTHER

University Hospital, LilleOTHER

david.tate@uzgent.be0032 9 332 23 00