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

July 11, 2017 updated by: Virendra Joshi, Ochsner Health System
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 Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Approximately 10 samples of 3 specific tissue types (specified as the 3 groups) will be collected as well as control samples. The number of patients enrolled may vary due to the variance of tissue type per patient. Patients will be informed that the number of patients enrolled will depend on the number of tissues needed for the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
(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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbial community profiling
Time Frame: 9 months
16S Ribosomal RNA (rRNA)gene sequencing
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generate a tissue microarray
Time Frame: 9 months
After retrieval of blocks, an experienced pathologist will mark the relevant tissue areas to process into microarray
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Collaborators

The University of Queensland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 20, 2017

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 10, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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