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

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01281618
First received: January 20, 2011
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Barrett's Esophagus
 Procedure: 24 hour pH study and upper endoscopy (EGD)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions GERD
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • activated myofibroblasts [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Tissue specimens from Barrett's esophagus


Enrollment: 48
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281618

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
  More Information

No publications provided

Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01281618     History of Changes
Other Study ID Numbers: 07-004899
Study First Received: January 20, 2011
Last Updated: May 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's esophagus

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Digestive System Abnormalities
Digestive System Diseases
 Esophageal Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on May 19, 2013