Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy (ULSBE)

The purpose of this study is to evaluate the Endosign capsule sponge test as a novel surveillance method in patients with an ultralong-segment Barrett's esophagus.

Study Overview

• Status: Recruiting
• Conditions: Barrett Esophagus
• Intervention / Treatment: Device: EndoSign

Detailed Description

In this study we will investigate the concordance between the Endosign capsule sponge test and esophagogastroduodenoscopy (EGD) by an expert endoscopist to detect dysplasia and/or esophageal adenocarcinoma (EAC) in patients with an ultralong-segment Barrett's esophagus. Patients will receive both the Endosign test and an EGD, after which we will compare both outcomes. To detect dysplasia and/or EAC on the cells collected by the Endosign test, we will look at cellular atypia and use p53 immunohistochemistry and novel biomarkers. In the future the Endosign test could perhaps replace EGD in the surveillance of Barrett's esophagus patients.

• Study Type: Interventional
• Enrollment (Estimated): 137
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Elise C de Groen, MSc; Phone Number: 003110 703 16 93; Email: a.degroen@erasmusmc.nl
• Study Contact Backup: Name: Judith Honing, MSc, PhD; Phone Number: 003110 703 16 93; Email: j.honing@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 1315 GD
      • Recruiting
      • Erasmus Medisch Centrum
      • Contact: Anne-Elise C de Groen, MSc in Medicine; Phone Number: +31 6 29 56 33 36; Email: a.degroen@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any participant 18 years and above, with ultralong-segment Barrett's esophagus and clinically fit for an endoscopy
• Ability to provide informed consent

Exclusion Criteria:

• Individuals with a diagnosis of an oro-pharynx, esophageal or gastro-esophageal tumor (T2 staging and above), or symptoms of dysphagia
• Esophageal varices or stricture requiring dilatation of the esophagus
• Individuals who have had a cerebrovascular event < 6 months prior where their swallowing has been affected
• Patients who have had previous treatments such as Photodynamic therapy (PDT), Radiofrequency ablation (RFA) or Argon Plasma Coagulation (APC) for dysplastic Barrett's esophagus
• Participants who are unable to provide informed consent
• Participants under age 18 years

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

Experimental: Study group; Subjects will receive the EndoSign test prior to their scheduled clinically indicated upper endoscopy by an expert endoscopist, per routine standard of care. Additional biopsies will be taken and 10cc of blood will be collected from the cannula used for sedation. Subjects will also receive three questionnaires regarding baseline characteristics, gastrointestinal symptoms and acceptability.

Device: EndoSign; The EndoSign cell collection device is a non-endoscopic capsule sponge device used to collect pan-esophageal samples. The Endosign procedure consists of an expandable, spherical mesh, which is attached to a string and contained within a soluble capsule. Seven minutes after swallowing (once the capsule has dissolved), the spherical mesh, which measures around 3cm in diameter is retrieved by pulling on the string. Upon retrieval the capsule-sponge scrapes against the surface of the top of the stomach and esophagus and collects epithelial cells. The capsule-sponge sample is then placed into a preservative fluid and the specimen is processed for molecular tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma	We will determine the concordance between the EndoSign test and upper endoscopy by an expert endoscopist to detect dysplasia and/or esophageal adenocarcinoma in patients with an ultralong-segment Barrett's esophagus.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient rating of both the EndoSign procedure and upper endoscopy on an experience scale	Patients with an ultralong Barrett esophagus will rate their experience with both the Endosign procedure and endoscopy on a scale from 1 - 10, with 1 being the worst experience ever and 10 the best experience ever. These results will be compared to assess which procedure is generally more acceptable to patients.	3 years
Sensitivity & specificity	To determine the sensitivity and specificity of the EndoSign to detect any form of dysplasia or esophageal adenocarcinoma in a cohort of ultralong-segment Barrett's esophagus patients.	3 years
Additional value of p53 immunohistochemistry	To determine the additional value of p53 immunohistochemistry in risk stratifying patients with ultralong-segment Barrett's esophagus.	3 years
Accuracy of a new risk stratification model for neoplastic progression	We will determine the accuracy of a newly developed risk stratification model that predicts which patients with an ultralong-segment Barrett's esophagus have the highest chance of neoplastic progression. We will use both clinical risk factors and p53 immunohistochemistry.	3 years
Accuracy of a new shallow Whole Genome Sequencing assay to predict neoplastic progression	We will determine the accuracy of a new shallow Whole Genome Sequencing (sWGS) assay for predicting neoplastic progression in patients with an ultralong Barrett's esophagus.	3 years
Validation of the sensitivity of a current methylation-based sequencing approach to predict neoplastic progression	We aim to validate the sensitivity of a current sequencing approach using both methylation and genome instability to detect neoplastic progression in patients with an ultralong Barrett's esophagus.	3 years

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: University of Cambridge; Cyted Health Inc
• Investigators: Principal Investigator: Judith Honing, MSc, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: NL87577.078.24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No