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 Recruiting DMC

• 2 other identifiers: CTMS33247101136935
• Study Type: interventional
• Target: 266
• Locations: 7 countries
• Sites: 10

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.

Conditions

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

Keywords

Barrett Esophagus; Barrett; DNA FISH; Genetic profiling; Adenocarcinoma; Brush cytology; Cancer worry; Disease free survival; Randomized controlled trial; RCT; Endoscopic mucosal resection; Endoscopic submucosal dissection; EMR; ESD; Quality of life; Health-Economic analysis

Outcome Measures

Primary Outcomes (3)

• Disease recurrence

  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

  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

  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 Outcomes (17)

• Clonal diversity score

  Between the baseline endoscopy (visit 1) and first endoscopy after endoscopic resection (visit 2)

• Disease stage

  From patient inclusion until three years after endoscopic eradication therapy

• Missing data ePRO

  From start of inclusion until three years after endoscopic eradication

• Caregiver's satisfaction

  From start inclusion until three years after endoscopic eradication

• Drop-out

  From start inclusion until three years after endoscopic eradication

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention arm will be informed by the investigator on their genetic risk profile.

Other: Risk profile disclosure

Control

NO INTERVENTION

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.

Interventions

Risk profile disclosure OTHER

Participants in the intervention arm will be informed by the investigator on their genetic risk profile.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (10)

Antwerp University Hospital

Edegem, Antwerpen, 2650, Belgium

Location

Sint-Augustinus Hospital (ZAS)

Wilrijk, Antwerpen, 2610, Belgium

Location

Ghent University Hospital (UZ Gent)

Ghent, Belgium, 9000, Belgium

Location

AZ Delta

Roeselare, Belgium, 8800, Belgium

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

CHU LILLE - Centre Hospitalier Universitaire de Lille

Lille, 59000, France

Location

University Hospital Leipzig

Leipzig, Leipzig, 04103, Germany

Location

St James's Hospital

Dublin, D08 NHY1, Ireland

Location

IRCCS Ospedale San Raffaele

Milan, Milano, 20132, Italy

Location

Karolinska University Hospital

Solna, SE-171 76, Sweden

Location

Related Links

• Endeavor EU Website

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Martin Wyckmans, Resident Physician

CONTACT

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

Luka Van der Veken, Master Biomedical Sciences

CONTACT

+3234368249; luka.vanderveken@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In this trial, there will be two arms: * Control group = dubbel blind (investigator and patient are blinded for the results of the risk profile). * Intervention group = open label = patients will be informed by the investigator on their risk profile.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 6, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 6, 2026

Record last verified: 2026-02

Locations

DK (1); SE (1); IT (1); BE (4); IE (1); FR (1); DE (1)