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

Not Applicable

Not yet recruiting

• Conditions: Barrett Esophagus

• Registration Number: NCT06720636
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Study Start: 2025-01
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 137

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma	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 Outcome Measures

Name	Time	Method
Patient rating of both the EndoSign procedure and upper endoscopy on an experience scale	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.
Sensitivity & specificity	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.
Additional value of p53 immunohistochemistry	3 years	To determine the additional value of p53 immunohistochemistry in risk stratifying patients with ultralong-segment Barrett's esophagus.
Accuracy of a new risk stratification model for neoplastic progression	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.
Accuracy of a new shallow Whole Genome Sequencing assay to predict neoplastic progression	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.
Validation of the sensitivity of a current methylation-based sequencing approach to predict neoplastic progression	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.