The Microenvironment in Barrett's Esophagus

Barrett Esophagus Clinical Trial

— BETRNet2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060642
• Other study ID #: AAAQ8763
• Secondary ID: NCI U54 CA163004
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: November 30, 2022

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: November 30, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Esophageal Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Mayo Clinic, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral and esophageal 16S rRNA gene sequencing	Oral and esophageal microbiome	1 day
Secondary	Esophageal tissue RNA-Seq	Esophageal tissue transcriptome	1 day
Secondary	Gastric aspirate mass spectrometry	Gastric aspirate bile acid composition	1 day