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

O

Ochsner Health System

Status

Unknown

Conditions

Esophageal Cancer
Barrett Esophagus

Study type

Observational

Funder types

Other

Identifiers

NCT03216135
2017113

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

50 participants in 3 patient groups

(GERD) with no Barrett's Esophagus
Description:
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
Description:
BE/columnar epithelium from patient diagnosed with BE and a control sample (area with no disease).
Cancer Tissue
Description:
Cancer tissue, and a control squamous epithelium from the same patient.

Trial contacts and locations

1

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Central trial contact

April Wendt; Virendra Joshi, MD

Data sourced from clinicaltrials.gov

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