Microbiome Involvement With Barrett's Esophagus and Progr... | NCT03216135

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

NCT03216135

Sponsor

Ochsner Health System

Status

Unknown status

Last Update Posted

Jul 13, 2017Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Barrett Esophagus
Esophageal Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2017Estimated

Primary Completion Date

Nov 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Jul 10, 2017

First Submission Date that Met QC Criteria

Jul 11, 2017

First Posted Date

Jul 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2017

Last Update Posted Date

Jul 13, 2017Actual

Name	Class
The University of Queensland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
(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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Virendra Joshi, MD	Contact	504-842-7690		vjoshi@ochsner.org
April Wendt	Contact			awendt@ochsner.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ochsner Health System	Recruiting	Kenner	Louisiana	70065	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001471	Barrett Esophagus
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

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