Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus (CR20)

May 3, 2013 updated by: Prasad G. Iyer, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
All subjects enrolled will undergo 24 hour pH followed by EGD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
activated myofibroblasts
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 20, 2011

First Submitted That Met QC Criteria

January 20, 2011

First Posted (Estimate)

January 24, 2011

Study Record Updates

Last Update Posted (Estimate)

May 6, 2013

Last Update Submitted That Met QC Criteria

May 3, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-004899

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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