Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus (CR20)
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|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|
|Actual Primary Completion Date :||June 2011|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281618
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|