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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01281618
Other study ID # 07-004899
Secondary ID
Status Completed
Phase N/A
First received January 20, 2011
Last updated May 3, 2013
Start date October 2008
Est. completion date June 2011

Study information

Verified date May 2013
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
24 hour pH study and upper endoscopy (EGD)
All subjects enrolled will undergo 24 hour pH followed by EGD.

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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