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

NCT ID: NCT01281618

Last Updated: 2013-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Barrett's Esophagus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Those with barrett's esophagus

Those with barrett's esophagus: no dysplasia or low grade dysplasia

24 hour pH study and upper endoscopy (EGD)

Intervention Type PROCEDURE

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

Interventions

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24 hour pH study and upper endoscopy (EGD)

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment \>/= 1 cm
2. Absence of dysplasia or LGD on biopsies within the past 5 years
3. Ability to provide informed consent
4. Age between 18 years and 90 years at study entry.

Exclusion Criteria

1. Eastern Cooperative Oncology Group performance status 3 or 4
2. Inability to tolerate endoscopic procedures
3. Pregnancy: Females of child-bearing age will be screened with pregnancy test.
4. Prior esophageal surgery, or cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Prasad G. Iyer

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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07-004899

Identifier Type: -

Identifier Source: org_study_id

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