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The Microenvironment in Barrett's Esophagus

NCT03060642 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 155

Last updated 2024-04-05

No results posted yet for this study

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

Interventions

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Subjects swallow a tethered capsule sponge sampling device, which is then withdrawn through the mouth after an interval of 5 minutes.

DEVICE

Electronic nose device

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

Sponsors & Collaborators

Principal Investigators

  • Julian A. Abrams, MD, MS · Columbia University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2021-04-30
Completion
2022-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03060642 on ClinicalTrials.gov