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

This study has been completed.
Sponsor:
Collaborator:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  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
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014