Barrett's esophagus Barrett food pipe
Conditions
Interventions
The participants will be asked to swallow the Endosign test prior to their 
standard-of-care endoscopy on the same day, or during their outpatient clinic appointment soon after endoscopy. The capsule-sponge test is a pill 
on a string which the patient swallows under guidance of a dedicated nurse or 
doctor. Once the pill reaches the stomach, it dissolves and a mesh unfolds 
within approximately 7 minutes. After this period the nurse or doctor will pull 
back the sponge, and on the way out the sponge scrapes cells from the esophagus 
which can be analyzed in the laboratory. Using p53 and morphological features 
the sponge is able to identify high-risk features corresponding with dysplasia.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Any participant 18 years and above, with ULSBE and clinically fit for an endoscopy • Ability to provide informed consent
Exclusion criteria
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 within the last 2 years • 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 BE • Participants who are unable to provide informed consent • Participants under age 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to investigate the concordance of the Endosign test to predict any grade of dysplasia or EAC in ULSBE patients compared to surveillance endoscopy by a BE expert. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are: • To determine the acceptability of the Endosign test in a ULSBE surveillance cohort • To determine the sensitivity and specificity of the capsule-sponge to detect any form of dysplasia or EAC in a cohort of ULSBE patients • To determine the additional value of p53 IHC in risk stratifying patients with ULSBE • To develop a risk stratification model for ULSBE patients using clinical risk factors and p53 IHC • To investigate whether a newly developed sWGS panel could improve the diagnostic accuracy of the capsule-sponge test • To validate the sensitivity of the current sequencing approach using methylation and instability to detect neoplastic progression, and investigate it's prognostic sensitivity in NDBE patients.• Feasibility of microbiome sampling with EndoSign and subsequent analysis of microbiome differences in saliva, oral swabs and EndoSign samples between NDBE, and BE with dysplasia | — |
Countries
Netherlands
Contacts
Public ContactAC de Groen
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed