The Microenvironment in Barrett's Esophagus

NCT ID: NCT03060642

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 155 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2022-11-30

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Barrett's esophagus

Barrett's esophagus, without or with dysplasia or adenocarcnoma

Tethered capsule sponge

Intervention Type: DEVICE

Subjects swallow a tethered capsule sponge sampling device, which is then withdrawn through the mouth after an interval of 5 minutes.

Electronic nose device

Intervention Type: DEVICE

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

Controls

Non-BE endoscopic controls

Tethered capsule sponge

Intervention Type: DEVICE

Subjects swallow a tethered capsule sponge sampling device, which is then withdrawn through the mouth after an interval of 5 minutes.

Electronic nose device

Intervention Type: DEVICE

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

Interventions

Tethered capsule sponge

Subjects swallow a tethered capsule sponge sampling device, which is then withdrawn through the mouth after an interval of 5 minutes.

Intervention Type: DEVICE

Electronic nose device

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

Intervention Type: DEVICE

Other Intervention Names

EsophaCap; Aeonose

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Julian A Abrams, MD

Assistant Professor of Medicine and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julian A. Abrams, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Mayo Clinic

Rochester, Minnesota, United States

Columbia University Medical Center

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Iyer PG, Slettedahl SW, Mahoney DW, Giakoumopoulos M, Olson MC, Krockenberger M, Taylor WR, Foote P, Berger C, Leggett C, Wu TT, Antpack E, Falk GW, Ginsberg GG, Abrams JA, Lightdale CJ, Ramirez F, Kahn A, Wolfsen H, Konda V, Trindade AJ, Kisiel JB. Algorithm Training and Testing for a Nonendoscopic Barrett's Esophagus Detection Test in Prospective Multicenter Cohorts. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1596-1604.e4. doi: 10.1016/j.cgh.2024.03.003. Epub 2024 Mar 19.

Reference Type: DERIVED

PMID: 38513982 (View on PubMed)

Other Identifiers

NCI U54 CA163004-09

Identifier Type: OTHER

Identifier Source: secondary_id

AAAQ8763

Identifier Type: -

Identifier Source: org_study_id