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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03216135
• Other study ID #: 2017113
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2017
• Last updated: July 11, 2017
• Start date: July 20, 2017
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Ochsner Health System
• Contact: Virendra Joshi, MD
• Phone: 504-842-7690
• Email: vjoshi[@]ochsner.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Esophageal Cancer
• Esophageal Neoplasms

Locations

Country	Name	City	State
United States	Ochsner Health System	Kenner	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Ochsner Health System	The University of Queensland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial community profiling	16S Ribosomal RNA (rRNA)gene sequencing	9 months
Secondary	Generate a tissue microarray	After retrieval of blocks, an experienced pathologist will mark the relevant tissue areas to process into microarray	9 months