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Spots Global Cancer Trial Database for Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus

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Trial Identification

Brief Title: Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus

Official Title: Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus

Study ID: NCT00573911

Study Description

Brief Summary: Patients with Barrett's Esophagus are known to have excessive distal esophageal acid exposure comparable to patients with erosive esophagitis. A significant proportion of patients with BE who are not symptomatic on treatment continue to have persistent acid reflux. High dose esomeprazole is able to control acid reflux in patients with BE. The effect of acid reflux on Barrett's esophagus stroma is currently unknown. It is our hypothesis that stromal fibroblast activation in Barrett's esophagus is influenced by acid reflux. The specific aim of this proposal will be: To assess the association between acid reflux and subepithelial fibroblasts in Barrett's esophagus.

Detailed Description: We will conduct a prospective cohort study to assess the degree of stromal activation in patients with LSBE (without dysplasia) who have adequate and inadequate control of acid reflux in the distal esophagus. The study will be conducted in two phases. Phase 1 (Pilot): 20 patients with LSBE without dysplasia will undergo endoscopy with biopsies and a 24 hour pH study on treatment. Patients will then be divided into 2 groups: * Group A (GER): Those with ongoing acid reflux (characterized by either presence of esophagitis \[LA classification B,C or D1\] on endoscopy, and/or a positive pH study on treatment defined using standard criteria) * Group B (NGER): Those with controlled acid reflux (negative endoscopy and pH study on treatment). Stromal markers that will be assessed and compared between the 2 groups will include: presence of activated myofibroblasts (detected by immunohistochemistry for vimentin and smooth muscle actin).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic, Rochester, Minnesota, United States

Contact Details

Name: Prasad G Iyer, M.D.

Affiliation: Mayo Clinic

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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