Clinical trial NCT03216135: Microbiome Involvement With Barrett's Esophagus and Progression to Esophageal Adenocarcinoma
Official title: Microbiome Involvement With Barrett's Esophagus and Progression to Esophageal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Barrett Esophagus
Esophageal Cancer
Keywords: Microbiome
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: The University of Queensland
First posted: 2017-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 10 samples of 3 specific tissue types (specified as the 3 groups) will be collected as well as control samples. The number of patients enrolled may vary due to the variance of tissue type per patient. Patients will be informed that the number of patients enrolled will depend on the number of tissues needed for the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbial community profiling
timeFrame: 9 months
Secondary outcomes:
measure: Generate a tissue microarray
timeFrame: 9 months
Other outcomes:
Locations:
city: Kenner
country: United States
facility: Ochsner Health System
state: Louisiana
Study officials:
References: