Microbiome Involvement With Barrett's Esophagus and Progression to Esophageal Adenocarcinoma

• Conditions: Esophageal Cancer; Barrett Esophagus

• Registration Number: NCT03216135
• Lead Sponsor: Ochsner Health System

Brief Summary

This study will examine the hypothesis that altered esophageal microbiome leads to the development of esophageal adenocarcinoma (EAC). The aims of the project are, firstly the confirmation of relational data on the study cohort, using the methods developed and applied at the laboratory at University of Queensland Diamantina Institute (UQDI). Second, to generate a tissue microarray resource future tissue in-situ validation of microbes. And finally, to develop a biobank of clinical isolates of relevant esophageal microbes for future functional studies.

Detailed Description

Gastroesophageal reflux disease, GERD, can lead to a change of the esophagus lining to a protective cell type, termed Barrett's esophagus (BE). A diagnosis of BE greatly increases the risk of developing esophageal adenocarcinoma (EAC). The incidence of EAC has been rapidly rising in the last 30 years, and the cancer has a high mortality rate. Understanding the involvement of the esophageal microbiota could lead to prevention strategies to this increasing health concern.

This study will examine the hypothesis that altered esophageal microbiome leads to the development of esophageal adenocarcinoma (EAC). The aims of the project are, firstly the confirmation of relational data on the study cohort, using the methods developed and applied at the laboratory at University of Queensland Diamantina Institute (UQDI). Second, to generate a tissue microarray resource future tissue in-situ validation of microbes. And finally, to develop a biobank of clinical isolates of relevant esophageal microbes for future functional studies.

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-11
• Last Update Submitted: 2017-07-11
• Study First Posted: 2017-07-13
• Last Update Posted: 2017-07-13
• Study Start: 2017-07-20
• Primary Completion: 2017-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Male or females >18 years of age with known or suspected GERD, Barrett's Esophagus and or esophageal adenocarcinoma or from patients who have a history of either condition.

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbial community profiling	9 months	16S Ribosomal RNA (rRNA)gene sequencing

Secondary Outcome Measures

Name	Time	Method
Generate a tissue microarray	9 months	After retrieval of blocks, an experienced pathologist will mark the relevant tissue areas to process into microarray

Trial Locations

Locations (1)

Ochsner Health System; 🇺🇸 Kenner, Louisiana, United States