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Completed

NCT Number: NCT03060642

The Microenvironment in Barrett's Esophagus

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(for BE patients)

  • History of histologically confirmed BE, defined as endoscopically-suspected BE with intestinal metaplasia with goblet cells on esophageal biopsies
  • BE length M≥2
  • Taking proton pump inhibitors at least once daily for 3 months prior to enrollment
  • Age ≥18

Exclusion criteria

  • History of gastric cancer or esophageal squamous cell cancer
  • History of gastric or esophageal surgery
  • Use of antibiotics or systemic immunosuppressants within three months prior to the date of endoscopy (intranasal and inhaled steroids are allowed)
  • Known untreated esophageal stricture or uninvestigated dysphagia
  • Inability to give informed consent
  • (BE patients only) History of prior endoscopic therapy for BE except a history of prior endoscopic mucosal resection (EMR) of focal lesions without subsequent ablative therapy is permitted

Treatment and study plan

Tethered capsule sponge

Device

Subjects swallow a tethered capsule sponge sampling device, which is then withdrawn through the mouth after an interval of 5 minutes.

Other names: EsophaCap

Electronic nose device

Device

Subjects breathe into the device, which then records an exhaled volatile organic compounds (VOC) signature.

Other names: Aeonose

Primary outcomes

  1. Oral and esophageal 16S rRNA gene sequencing

    Time frame: 1 day

    Oral and esophageal microbiome

Secondary outcomes

  1. Esophageal tissue RNA-Seq

    Time frame: 1 day

    Esophageal tissue transcriptome

  2. Gastric aspirate mass spectrometry

    Time frame: 1 day

    Gastric aspirate bile acid composition

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Mayo Clinic
  • University of Pennsylvania

Registry information

Official study title

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

Acronym: BETRNet2

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Feb 23, 2017
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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