Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus (CR20)
|ClinicalTrials.gov Identifier: NCT01281618|
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : May 6, 2013
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 or disease||Intervention/treatment|
|Barrett's Esophagus||Procedure: 24 hour pH study and upper endoscopy (EGD)|
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|Official Title:||Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus|
|Study Start Date :||October 2008|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2011|
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.
- 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281618
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|