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

NCT01281618 | Completed

• 1 other identifier: 07-004899
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett's Esophagus

Keywords

Barrett's esophagus

Outcome Measures

Primary Outcomes (1)

• activated myofibroblasts

  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.

  6 months

Study Arms (1)

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)

Interventions

24 hour pH study and upper endoscopy (EGD) PROCEDURE

All subjects enrolled will undergo 24 hour pH followed by EGD.

Those with barrett's esophagus

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue specimens from Barrett's esophagus

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Gastroscopy; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 24, 2011
• Study Start: October 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 6, 2013

Record last verified: 2013-05

Locations

US (1)