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 (Endeavor-2)

March 2, 2026 updated by: University Hospital, Antwerp

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Antwerp University Hospital
      • Wilrijk, Antwerpen, Belgium, 2610
        • Sint-Augustinus Hospital (ZAS)
        • Contact:
        • Principal Investigator:
          • Thomas Botelberge
    • Belgium
      • Ghent, Belgium, Belgium, 9000
        • Ghent University Hospital (UZ Gent)
        • Contact:
        • Principal Investigator:
          • David Tate
      • Roeselare, Belgium, Belgium, 8800
        • AZ Delta
        • Contact:
        • Principal Investigator:
          • Dominiek Dewulf
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Prof. Dr. Michael Patrick Achiam
  • France
      • Lille, France, 59000
        • CHU LILLE - Centre Hospitalier Universitaire de Lille
        • Principal Investigator:
          • Guillaume Piessen
        • Contact:
  • Germany
    • Leipzig
      • Leipzig, Leipzig, Germany, 04103
  • Ireland
      • Dublin, Ireland, D08 NHY1
        • St James's Hospital
        • Contact:
          • Prof. Jacintha O'Sullivan
          • Phone Number: +353 1 8962149
          • Email: OSULLIJ4@tcd.ie
        • Principal Investigator:
          • Jessie Elliot
  • Italy
    • Milano
      • Milan, Milano, Italy, 20132
        • Irccs Ospedale San Raffaele
        • Contact:
        • Principal Investigator:
          • Federica Ungaro
  • Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants in the intervention arm will be informed by the investigator on their genetic risk profile.
Other: Risk profile disclosure
Participants in the intervention arm will be informed by the investigator on their genetic risk profile.
No Intervention: Control
Participants in the control arm will not be informed by the investigator on their genetic risk profile. Both the participant and the investigator are not aware of the genetic risk profile.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease recurrence
Time Frame: From endoscopic resection up to three years after endoscopic eradication therapy
Extraluminal recurrence (regional, distal) of cancer, endoluminal recurrence (metachronous, local) of cancer, endoluminal recurrence of dysplasia
From endoscopic resection up to three years after endoscopic eradication therapy
Cancer Worry Scale
Time Frame: After cessation of endoscopic eradication therapy (EET), assessed up to 5 years after inclusion
Cancer Worry Scale (total score, 8-item version) after cessation of endoscopic eradication therapy (EET)
After cessation of endoscopic eradication therapy (EET), assessed up to 5 years after inclusion
Economic costs
Time Frame: From end of endoscopic eradication therapy until three years after endocsopic eradication therapy
Economic costs in euro for surveillance programme (including endoscopic procedures, biomarker analysis and materials)
From end of endoscopic eradication therapy until three years after endocsopic eradication therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clonal diversity score
Time Frame: Between the baseline endoscopy (visit 1) and first endoscopy after endoscopic resection (visit 2)
Clonal diversity score measurements based on DNA-FISH brush cytology samples before and after endoscopic resection
Between the baseline endoscopy (visit 1) and first endoscopy after endoscopic resection (visit 2)
Disease stage
Time Frame: From patient inclusion until three years after endoscopic eradication therapy
Disease stage (histopathological disease stage of resection specimen, TNM-classification) based on EMR/ESD, EUS, PET-CT, pathology and cytology
From patient inclusion until three years after endoscopic eradication therapy
Missing data ePRO
Time Frame: From start of inclusion until three years after endoscopic eradication
Missing data events for ePRO and paper questionnaires
From start of inclusion until three years after endoscopic eradication
Caregiver's satisfaction
Time Frame: From start inclusion until three years after endoscopic eradication
Caregiver's responses to questionnaire on application of biomarker-based health information
From start inclusion until three years after endoscopic eradication
Drop-out
Time Frame: From start inclusion until three years after endoscopic eradication
Drop-out/delay events from allocated endoscopic surveillance, reasons for delays/drop-out
From start inclusion until three years after endoscopic eradication
Follow-up years
Time Frame: From end of endoscopic eradication therapy until year three after endoscopic eradication
Total follow-up years: mean and average follow-up years per patient
From end of endoscopic eradication therapy until year three after endoscopic eradication
Cancer worry scale longitudinal
Time Frame: From start of inclusion until year three after endscopic eradication therapy
Cancer worry scale total score at predetermined, clinically relevant timepoints
From start of inclusion until year three after endscopic eradication therapy
EQ-5D-5L
Time Frame: From start of inclusion until three years after endoscopic eradication
EQ-5D-5L utility score and Visual Analogue Scale score at predetermined, clinically relevant timepoints
From start of inclusion until three years after endoscopic eradication
Quality adjusted life years (QALY)
Time Frame: From start of inclusion until three years after endoscopic eradication
QALY based on clinical endpoints, cancer worry scale results and EQ-5D-5L results
From start of inclusion until three years after endoscopic eradication
Endoscopy timepoint
Time Frame: From end of endoscopic resection until three years after endoscopic eradication therapy
Endoscopy timepoint at detected recurrence
From end of endoscopic resection until three years after endoscopic eradication therapy
Histopathological disease stage
Time Frame: From end of endoscopic resection until three years after endoscopic eradication
Histopathological disease stage of detected recurrence
From end of endoscopic resection until three years after endoscopic eradication
Treatment stage recurrence
Time Frame: From endoscopic resection until three years after endocopic eradication
Treatment stage of detected recurrence (before / during / after RFA)
From endoscopic resection until three years after endocopic eradication
Mortality events
Time Frame: From endoscopic resection until three years after endoscopic eradication
Overall and disease-specific mortality events
From endoscopic resection until three years after endoscopic eradication
Number of ablation sessions
Time Frame: From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion
Amount of ablation sessions needed to achieve CE-IM
From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion
Number of CE-IM patients
Time Frame: From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion
Number of patients that reach CE-IM
From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion
Number of RFA therapy-resistant patients
Time Frame: From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion
Number of RFA therapy-resistant patients defined as >50% residual Barrett Esophagus after first RFA session, or when residual BE is present after cessation of RFA therapy
From start of endoscopic eradication therapy until end of endoscopic eradication, assessed up to 5 years after inclusion
Local recurrence
Time Frame: From endoscopic resection until three years after endoscopic eradication
Local recurrence of adenocarcinoma (around the EMR/ESD scar site)
From endoscopic resection until three years after endoscopic eradication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Karolinska University Hospital
Karolinska Institutet
Rigshospitalet, Denmark
Heinrich-Heine University, Duesseldorf
University of Leipzig
University Hospital, Ghent
AZ Delta
University of Dublin, Trinity College
St. James's Hospital, Ireland
GZA Ziekenhuizen Campus Sint-Augustinus
Universitätsklinikum Leipzig
IRCCS Ospedale San Raffaele
Lille University Hospital
Amsterdam UMC
Radbound University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMS33247
  • 101136935 (Other Grant/Funding Number: European Commission (HORIZON EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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