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

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.

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

24 hour pH study and upper endoscopy (EGD)

Procedure

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Acronym: CR20

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Jan 24, 2011
Registry last updated: May 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed