BETRNet2: The Microenvironment in Barrett's Esophagus

Sponsor

Columbia University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03060642

Collaborator

Mayo Clinic (Other), University of Pennsylvania (Other)

155

Enrollment

Locations

50.9

Anticipated Duration (Months)

51.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Barrett Esophagus Esophageal Adenocarcinoma	Device: Tethered capsule sponge Device: Electronic nose device

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.

Study Design

Study Type:

Observational

Actual Enrollment :

155 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Apr 30, 2021

Anticipated Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Barrett's esophagus Barrett's esophagus, without or with dysplasia or adenocarcnoma	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. Other Names: EsophaCap Device: Electronic nose device Subjects breathe into the device, which then records an exhaled volatile organic compounds (VOC) signature. Other Names: Aeonose
Controls Non-BE endoscopic controls	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. Other Names: EsophaCap Device: Electronic nose device Subjects breathe into the device, which then records an exhaled volatile organic compounds (VOC) signature. Other Names: Aeonose

Arm

Intervention/Treatment

Barrett's esophagus

Barrett's esophagus, without or with dysplasia or adenocarcnoma

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.

Other Names:

EsophaCap

Device: Electronic nose device

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

Other Names:

Aeonose

Controls

Non-BE endoscopic controls

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.

Other Names:

EsophaCap

Device: Electronic nose device

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

Other Names:

Aeonose

Outcome Measures

Primary Outcome Measures

Oral and esophageal 16S rRNA gene sequencing [1 day]
Oral and esophageal microbiome

Secondary Outcome Measures

Esophageal tissue RNA-Seq [1 day]
Esophageal tissue transcriptome
Gastric aspirate mass spectrometry [1 day]
Gastric aspirate bile acid composition

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905
2	Columbia University Medical Center	New York	New York	United States	10032
3	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104