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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03216135

Enrollment

Registered

2017-07-13

Start date

2017-07-20

Completion date

2017-12-31

Last updated

2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett Esophagus, Esophageal Cancer

Keywords

Microbiome

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

Primary ContactVirendra Joshi, MD

vjoshi@ochsner.org504-842-7690

Backup ContactApril Wendt

awendt@ochsner.org

Outcome results