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Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus (CR20)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01281618
First received: January 20, 2011
Last updated: May 3, 2013
Last verified: May 2013

January 20, 2011
May 3, 2013
October 2008
June 2011   (final data collection date for primary outcome measure)
activated myofibroblasts [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01281618 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Tissue specimens from Barrett's esophagus

Non-Probability Sample

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

Barrett's Esophagus
Procedure: 24 hour pH study and upper endoscopy (EGD)
All subjects enrolled will undergo 24 hour pH followed by EGD.
Those with barrett's esophagus
Those with barrett's esophagus: no dysplasia or low grade dysplasia
Intervention: Procedure: 24 hour pH study and upper endoscopy (EGD)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01281618
07-004899
No
Prasad G. Iyer, Mayo Clinic
Mayo Clinic
National Institutes of Health (NIH)
Not Provided
Mayo Clinic
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP