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

NCT ID: NCT03216135

Last Updated: 2017-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-20

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Barrett Esophagus Esophageal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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(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).

No interventions assigned to this group

Barrett's Esophagus

BE/columnar epithelium from patient diagnosed with BE and a control sample (area with no disease).

No interventions assigned to this group

Cancer Tissue

Cancer tissue, and a control squamous epithelium from the same patient.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Queensland

OTHER

Sponsor Role collaborator

Ochsner Health System

OTHER

Sponsor Role lead

Responsible Party

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Virendra Joshi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ochsner Health System

Kenner, Louisiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Virendra Joshi, MD

Role: CONTACT

504-842-7690

April Wendt

Role: CONTACT

Facility Contacts

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Cris Molina

Role: primary

504-464-8314

April Wendt, RN

Role: backup

504-464-8499

Other Identifiers

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2017113

Identifier Type: -

Identifier Source: org_study_id

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