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 | Recruiting DMC

• 2 other identifiers: EDGE3788101136935
• Study Type: interventional
• Target: 50
• Locations: 6 countries
• Sites: 9

Brief Summary

This study serves, in part, to prepare for a future large cohort study. The goal of the study is:

• 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).

Conditions

Barrett's Esophagus; Esophageal Adenocarcinoma

Keywords

Barrett; Barrett's Esophagus; Endeavor; Esophageal cancer; Esophageal adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Success rate of brush, biopsy and blood samples obtained from different sites for analysis by HTP technologies

  We will determine the success rate of obtaining material from different sites for analysis by high throughput technologies (Next Generation Sequencing) of the brush, biopsy or blood samples. A rate of analysable cells of at least 80% of the specimens will be regarded as successful.

  6-12 months

• Success rate of DNA-FISH analyses on the brush cytology samples

  Our second primary outcome measure for this pilot study is successful DNA-FISH analysis (successful = at least 50 cells that can be analyzed in at least 80% of participants) on the brush cytology samples for defining the final risk model that will be applied in the randomized controlled trial following the pilot study.

  6-12 months

Secondary Outcomes (5)

• Accuracy of a DNA-FISH based risk model

  6-24 months

• Correlation of a DNA-FISH based risk model

  6-24 months

• Standard operating procedures for specimen collection

  6-24 months

• Standard operating procedures for logistical procedures

  6-24 months

• Successful participation and answering of questionnaires

  6-24 months

Study Arms (1)

Endoscopic brush cytology

OTHER

Each participant will receive all interventions. A routine endoscopy will be planned during which several minimally invasive interventions will be performed: drawing a blood sample (standard of care), brush cytology (not standard of care) and biopsies (standard of care) during the endoscopy.

Procedure: Endoscopic brush cytology

Interventions

Endoscopic brush cytology PROCEDURE

A total of four brush samples will be taken during the endoscopy. Other minimally invasive interventions during this study are standard of care.

Endoscopic brush cytology

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 early esophageal 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 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

Sponsors & Collaborators

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

Study Sites (9)

University Hospital Antwerp

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Sint-Augustinus Hospital (ZAS)

Wilrijk, Antwerpen, 2610, Belgium

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

AZ Delta

Roeselare, 8800, Belgium

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

CHU LILLE - Centre Hospitalier Universitaire de Lille

Lille, 59000, France

RECRUITING

St James's Hospital

Dublin, D08 NHY1, Ireland

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Milano, 20132, Italy

RECRUITING

Karolinska University Hospital

Solna, SE-171 76, Sweden

RECRUITING

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Study Officials

• Sheila Krishnadath

  Universitair Ziekenhuis Antwerpen (UZA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Toon Mertens

CONTACT

+3234368281; Toon.mertens@uza.be

Luka Van der Veken

CONTACT

+3234368249; luka.vanderveken@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 26, 2024
• Study Start: August 13, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2025-07

Locations

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