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

Sponsor

Ochsner Health System (Other)

Overall Status

Unknown status

CT.gov ID

NCT03216135

Collaborator

The University of Queensland (Other)

Enrollment

Location

4.4

Anticipated Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Barrett Esophagus Esophageal Cancer

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 20, 2017

Anticipated Primary Completion Date :

Nov 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
(GERD) with no Barrett's Esophagus Squamous epithelium from patient with gastroesophageal reflux disease (GERD) with no BE or EAC diagnosed will be collected and a control sample (area with no disease).
Barrett's Esophagus BE/columnar epithelium from patient diagnosed with BE and a control sample (area with no disease).
Cancer Tissue Cancer tissue, and a control squamous epithelium from the same patient.

Outcome Measures

Primary Outcome Measures

Microbial community profiling [9 months]
16S Ribosomal RNA (rRNA)gene sequencing

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ochsner Health System	Kenner	Louisiana	United States	70065

Sponsors and Collaborators

Ochsner Health System
The University of Queensland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Virendra Joshi, MD, Ochsner Health System

ClinicalTrials.gov Identifier:

NCT03216135

Other Study ID Numbers:

2017113

First Posted:

Jul 13, 2017

Last Update Posted:

Jul 13, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Virendra Joshi, MD, Ochsner Health System

Microbiome

Additional relevant MeSH terms:

Adenocarcinoma

Barrett Esophagus

Study Results

No Results Posted as of Jul 13, 2017