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NCT Number: NCT06720636

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

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.

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus Medisch Centrum

Rotterdam, South Holland, 1315 GD, Netherlands

Location status: Recruiting

Location contact

Anne-Elise C de Groen, MSc in Medicine

CONTACT

[email protected]

+31 6 29 56 33 36

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endosign

Device

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.

Primary outcomes

  1. Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma

    Time frame: 3 years

    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.

Secondary outcomes

  1. Patient rating of both the EndoSign procedure and upper endoscopy on an experience scale

    Time frame: 3 years

    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.

  2. Sensitivity & specificity

    Time frame: 3 years

    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. Additional value of p53 immunohistochemistry

    Time frame: 3 years

    To determine the additional value of p53 immunohistochemistry in risk stratifying patients with ultralong-segment Barrett's esophagus.

  4. Accuracy of a new risk stratification model for neoplastic progression

    Time frame: 3 years

    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.

  5. Accuracy of a new shallow Whole Genome Sequencing assay to predict neoplastic progression

    Time frame: 3 years

    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.

  6. Validation of the sensitivity of a current methylation-based sequencing approach to predict neoplastic progression

    Time frame: 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Elise C de Groen, MSc

CONTACT

[email protected]

003110 703 16 93

Judith Honing, MSc, PhD

CONTACT

[email protected]

003110 703 16 93

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Cyted Health Inc
  • University of Cambridge

Registry information

Acronym: ULSBE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 6, 2024
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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