NCT03060642

The Microenvironment in Barrett's Esophagus

Application of the Microbiome and Microenvironment to Novel Non-Endoscopic Screening and Surveillance in Barrett's Esophagus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to elucidate the relationship between the microbiome, inflammation, and the microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the end goal of developing a non-endoscopic testing strategy based on pathogenic factors to identify patients at highest risk for EAC. To accomplish this the investigators will enroll 100 patients with known BE (50 with dysplasia or EAC) and 50 subjects without BE undergoing upper endoscopy. Prior to endoscopy each subject will undergo three minimally invasive potential screening and surveillance tests: saliva (oral microbiome), breath test (exhaled volatile organic compounds), and tethered capsule sponge sampling (methylated DNA markers). The study will evaluate these novel tests in combination with clinical and anthropometric factors to describe an optimal strategy for BE screening and monitoring.

Detailed description

The investigators will perform a multi-center cross-sectional study of patients with Barrett's esophagus, with and without associated dysplasia or cancer, and controls without BE. Enrollment of controls will be stratified based on use of proton pump inhibitors (PPIs). The investigators plan to enroll an approximate total of 150 subjects: 100 BE patients (with or without associated dysplasia or cancer) * 50 subjects with non-dysplastic BE * 50 subjects with BE and dysplasia or EAC 50 controls * 25 controls on PPIs (at least once daily) * 25 controls not taking PPIs Various tests will be performed and samples collected on the day of endoscopy. These tests include: saliva samples, electronic nose device testing, tethered capsule sponge testing, dietary questionnaires, and collection of blood and gastrointestinal biosamples. Analyses of this data and samples will then be performed to address the specific aims above.

Conditions

• Barrett Esophagus
• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	Tethered capsule sponge	Subjects swallow a tethered capsule sponge sampling device, which is then withdrawn through the mouth after an interval of 5 minutes.
DEVICE	Electronic nose device	Subjects breathe into the device, which then records an exhaled volatile organic compounds (VOC) signature.

Timeline

• Start date: 2018-02-01
• Primary completion: 2021-04-30
• Completion: 2022-11-30
• First posted: 2017-02-23
• Last updated: 2024-04-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study