The Microenvironment in Barrett's Esophagus

NCT03060642 | Completed FDA Device

• 2 other identifiers: AAAQ8763NCI U54 CA163004-09
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 3

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.

Conditions

Barrett Esophagus; Esophageal Adenocarcinoma

Keywords

Microenvironment; Microbiome; Screening; Barrett Esophagus; Esophageal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Oral and esophageal 16S rRNA gene sequencing

  Oral and esophageal microbiome

  1 day

Secondary Outcomes (2)

• Esophageal tissue RNA-Seq

  1 day

• Gastric aspirate mass spectrometry

  1 day

Study Arms (2)

Barrett's esophagus

Barrett's esophagus, without or with dysplasia or adenocarcnoma

Device: Tethered capsule sponge; Device: Electronic nose device

Controls

Non-BE endoscopic controls

Device: Tethered capsule sponge; Device: Electronic nose device

Interventions

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Subjects swallow a tethered capsule sponge sampling device, which is then withdrawn through the mouth after an interval of 5 minutes.

Also known as: EsophaCap

Barrett's esophagus; Controls

Electronic nose device DEVICE

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

Also known as: Aeonose

Barrett's esophagus; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with or without Barrett's esophagus already scheduled for upper endoscopy.

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Mayo Clinic: collaborator
• University of Pennsylvania: collaborator

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 38513982 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Gastric Aspirate Tissue from the Esophagus

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Julian A. Abrams, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 23, 2017
• Study Start: February 1, 2018
• Primary Completion: April 30, 2021
• Study Completion: November 30, 2022
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

US (3)