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

Tracking Information
First Received Date ^ICMJE	January 20, 2011
Last Updated Date	May 3, 2013
Start Date ^ICMJE	October 2008
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 20, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01281618 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
Official Title ^ICMJE	Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Tissue specimens from Barrett's esophagus
Sampling Method	Non-Probability Sample
Study Population	Those diagnosed with barrett's esophagus confirmed by pathology with no dysplasia or low grade dysplasia
Condition ^ICMJE	Barrett's Esophagus
Intervention ^ICMJE	Procedure: 24 hour pH study and upper endoscopy (EGD) All subjects enrolled will undergo 24 hour pH followed by EGD.
Study Group/Cohort (s)	Those with barrett's esophagus Those with barrett's esophagus: no dysplasia or low grade dysplasia Intervention: Procedure: 24 hour pH study and upper endoscopy (EGD)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	48
Completion Date	June 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment >/= 1 cm Absence of dysplasia or LGD on biopsies within the past 5 years Ability to provide informed consent Age between 18 years and 90 years at study entry. Exclusion criteria: Eastern Cooperative Oncology Group performance status 3 or 4 Inability to tolerate endoscopic procedures Pregnancy: Females of child-bearing age will be screened with pregnancy test. Prior esophageal surgery, or cancer
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01281618
Other Study ID Numbers ^ICMJE	07-004899
Has Data Monitoring Committee	No
Responsible Party	Prasad G. Iyer, Mayo Clinic
Study Sponsor ^ICMJE	Mayo Clinic
Collaborators ^ICMJE	National Institutes of Health (NIH)
Investigators ^ICMJE	Not Provided
Information Provided By	Mayo Clinic
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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