Clinical trial NCT06720636: Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy
Official title: Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Barrett Esophagus
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Cyted Health Inc
name: University of Cambridge
First posted: 2024-12-06
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma
timeFrame: 3 years
Secondary outcomes:
measure: Patient rating of both the EndoSign procedure and upper endoscopy on an experience scale
timeFrame: 3 years
measure: Sensitivity & specificity
timeFrame: 3 years
measure: Additional value of p53 immunohistochemistry
timeFrame: 3 years
measure: Accuracy of a new risk stratification model for neoplastic progression
timeFrame: 3 years
measure: Accuracy of a new shallow Whole Genome Sequencing assay to predict neoplastic progression
timeFrame: 3 years
measure: Validation of the sensitivity of a current methylation-based sequencing approach to predict neoplastic progression
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Erasmus Medical Center
name: Judith Honing, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: