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 (Endeavor-1)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Barrett's Esophagus; Esophageal Adenocarcinoma
• Intervention / Treatment: Procedure: Endoscopic brush cytology

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Toon Mertens; Phone Number: +3234368281; Email: toon.mertens@uza.be
• Study Contact Backup: Name: Luka Van der Veken; Phone Number: +3234368249; Email: luka.vanderveken@uza.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • UZ Gent
    • Contact: Dr. David Tate; Phone Number: 0032 9 332 23 00; Email: david.tate@uzgent.be
    • Principal Investigator: Dr. David Tate
  • Roeselare, Belgium, 8800
    • Recruiting
    • AZ Delta
    • Contact: Dr. Dominiek De Wulf; Phone Number: +32 51 23 72 15
    • Principal Investigator: Dr. Dominiek De Wulf
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Recruiting
      • University Hospital Antwerp
      • Contact: Toon Mertens; Phone Number: +3234368281; Email: toon.mertens@uza.be
      • Contact: Luka Van der Veken; Phone Number: +3234368249; Email: luka.vanderveken@uza.be
      • Principal Investigator: Prof. Dr. Sheila Krishnadath
    • Wilrijk, Antwerpen, Belgium, 2610
      • Recruiting
      • Sint-Augustinus Hospital (ZAS)
      • Contact: Toon Mertens; Phone Number: +32 34 36 8281; Email: toon.mertens@uza.be
      • Principal Investigator: Dr. Thomas Botelberge
• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
    • Contact: Prof. Dr. Michael Patrick Achiam; Phone Number: +45 35 45 04 41; Email: michael.patrick.achiam.01@regionh.dk
    • Principal Investigator: Prof. Dr. Michael Patrick Achiam
• France
  • Lille, France, 59000
    • Recruiting
    • CHU LILLE - Centre Hospitalier Universitaire de Lille
    • Contact: Florence Nosal; Phone Number: +33320445751; Email: florence.nosal@chru-lille.fr
    • Principal Investigator: Prof. Dr. Guillaume Piessen
• Ireland
  • Dublin, Ireland, D08 NHY1
    • Recruiting
    • St James's Hospital
    • Contact: Prof. Jacintha O'Sullivan; Phone Number: +353 1 8962149; Email: OSULLIJ4@tcd.ie
    • Principal Investigator: Prof. Jacintha O Sullivan
• Italy
  • Milano
    • Milan, Milano, Italy, 20132
      • Recruiting
      • Irccs Ospedale San Raffaele
      • Contact: Dr. Federica Ungaro; Phone Number: +39 0226437864; Email: Ungaro.Federica@hsr.it
      • Principal Investigator: Dr. Silvio Danese
• Sweden
  • Solna, Sweden, SE-171 76
    • Recruiting
    • Karolinska University Hospital
    • Contact: Dr. Fredrik Klevebro; Email: fredrik.klevebro@regionstockholm.se
    • Principal Investigator: Dr. Fredrik Klevebro
    • Contact: Dr. Henrik Maltzman

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Endoscopic brush cytology; 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; A total of four brush samples will be taken during the endoscopy. Other minimally invasive interventions during this study are standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of a DNA-FISH based risk model	The first secondary outcome is the accuracy of a DNA-FISH based risk model to distinguish low risk from high-risk early Barrett cancers. This will be assessed by endoscopic imaging and histo-pathological outcomes.	6-24 months
Correlation of a DNA-FISH based risk model	The correlation of a DNA-FISH based risk model to distinguish low risk from high-risk early Barrett cancers with results obtained from Next Generation Sequencing.	6-24 months
Standard operating procedures for specimen collection	A standard operating procedure describing the best method for obtaining brush cytology specimens and for obtaining the right tissue specimens via endoscopy will be created. The best method will be determined by the quality and number of analysable cells.	6-24 months
Standard operating procedures for logistical procedures	A standard operating procedure (SOP) for the logistics for shipment, redistribution and storage of patient material and data of the different participating sites will be created based on the course of this pilot study. Interim logistical problems will be spontaneously reported by all sites and resolved with the central team. The final solutions ("best method") will be described in the SOP.	6-24 months
Successful participation and answering of questionnaires	The participation and answering of the quality of life questionnaires and anxiety level questionnaires of at least 70% of the patients will be seen as successful.	6-24 months

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Karolinska University Hospital; Karolinska Institutet; Radboud University Medical Center; 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; Universal Diagnostics; Amsterdam UMC
• Investigators: Principal Investigator: Sheila Krishnadath, Universitair Ziekenhuis Antwerpen (UZA)

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Esophageal adenocarcinoma; Barrett's Esophagus; Esophageal cancer; Endeavor; Barrett
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Precancerous Conditions; Esophageal Neoplasms; Barrett Esophagus; Adenocarcinoma Of Esophagus
• Other Study ID Numbers: EDGE3788; 101136935 (Other Grant/Funding Number: European Commission (HORIZON EU))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No