Recruiting

Observational Study

Sponsor:

Ochsner Health System

Code:

NCT03216135

Conditions

Barrett Esophagus

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Barrett Esophagus

Esophageal Cancer

Study ID

NCT03216135

Start date

Jul 20, 2017

Status verified date

Mar, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Nov, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

(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.

Primary outcome measure

  • Microbial community profiling [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Locations

Ochsner Health System

Recruiting

Kenner, Louisiana, United States, 70065

Contacts

More Information

Sponsor

Ochsner Health System

Last update posted

Jul 13, 2017

Last verified

Mar, 2017

Keywords

  • Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ochsner Health System on 2017-07-13.