Influence of Acid Reflux on Stromal Epithelial Interactio... | NCT01281618

Studies
Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus

NCT01281618

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

May 6, 2013Estimated

Enrollment

48Actual

Phase

Not provided

Conditions

Barrett's Esophagus

Interventions

24 hour pH study and upper endoscopy (EGD)

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

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jan 20, 2011

First Submission Date that Met QC Criteria

Jan 20, 2011

First Posted Date

Jan 24, 2011Estimated

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

May 3, 2013

Last Update Posted Date

May 6, 2013Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to determine the association between acid reflux and cell changes in Barrett's esophagus.

Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation.

Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive BE epithelial proliferation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Those with barrett's esophagus		Those with barrett's esophagus: no dysplasia or low grade dysplasia	Procedure: 24 hour pH study and upper endoscopy (EGD)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
24 hour pH study and upper endoscopy (EGD)	Procedure	All subjects enrolled will undergo 24 hour pH followed by EGD.	Those with barrett's esophagus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
activated myofibroblasts	The primary end point for the study will be the proportion of patients with activated myofibroblasts (defined as positive staining for SMA and vimentin with negative staining for Desmin, in > 50% of subepithelial myofibroblasts). This primary end point will be compared between the group with controlled acid reflux and the group without acid reflux.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment >/= 1 cm
Absence of dysplasia or LGD on biopsies within the past 5 years
Ability to provide informed consent
Age between 18 years and 90 years at study entry.

Exclusion criteria:

Eastern Cooperative Oncology Group performance status 3 or 4
Inability to tolerate endoscopic procedures
Pregnancy: Females of child-bearing age will be screened with pregnancy test.
Prior esophageal surgery, or cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Those diagnosed with barrett's esophagus confirmed by pathology with no dysplasia or low grade dysplasia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D001471	Barrett Esophagus

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005773	Gastroscopy
D016145	Endoscopy, Digestive System

Ancestor Terms

ID	Term
D016099	Endoscopy, Gastrointestinal
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided