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Recruiting NCT06720636

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

No phase Interventional Barrett Esophagus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EndoSign.
Who it may be relevant to
Registry conditions: Barrett Esophagus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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 sto

Primary outcome measures

  • Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma [Time frame: 3 years]
Secondary outcome measures (6)
  • Patient rating of both the EndoSign procedure and upper endoscopy on an experience scale [Time frame: 3 years]
  • Sensitivity & specificity [Time frame: 3 years]
  • Additional value of p53 immunohistochemistry [Time frame: 3 years]
  • Accuracy of a new risk stratification model for neoplastic progression [Time frame: 3 years]
  • Accuracy of a new shallow Whole Genome Sequencing assay to predict neoplastic progression [Time frame: 3 years]
  • Validation of the sensitivity of a current methylation-based sequencing approach to predict neoplastic progression [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 1 center
  • Erasmus Medisch Centrum — Rotterdam

Identifiers

NCT: NCT06720636 · NL87577.078.24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗