The Microenvironment in Barrett's Esophagus
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/22/2018 |
| Start Date: | February 1, 2018 |
| End Date: | July 1, 2021 |
Application of the Microbiome and Microenvironment to Novel Non-Endoscopic Screening and Surveillance in Barrett's Esophagus
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.
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.
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.
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.
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 EMR of focal lesions without subsequent ablative therapy is permitted
We found this trial at
3
sites
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Julian Abrams
Phone: 212-304-5595
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Gary Falk
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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