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Micro-RNA (miR) Expression in Upper Gastrointestinal Mucosal Tissue

This study has been completed.
Information provided by (Responsible Party):
Kenneth R. DeVault, M.D., Mayo Clinic Identifier:
First received: May 27, 2009
Last updated: February 11, 2015
Last verified: February 2015
This is a laboratory-based, exploratory study using tissue obtained from our clinical practice. The purpose of this study is to confirm our ability to characterize miR expression in various tissues (proximal and distal esophagus, stomach and duodenum) obtained from the upper gastrointestinal tract in preparation for the study of MiR in patients with Barrett's esophagus and other inflammatory conditions of the upper gastrointestinal tract.

Barrett's Esophagus
Esophageal Adenocarcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Micro-RNA (miR) Expression in Upper Gastrointestinal Mucosal Tissue: A Potential Target for Understanding and Preventing the Progression of Barrett's Esophagus

Resource links provided by NLM:

Further study details as provided by Kenneth R. DeVault, M.D., Mayo Clinic:

Primary Outcome Measures:
  • miR expression between tissue from Barrett's esophagus and that from normal tissues [ Time Frame: time it takes to have standard of care biopsies taken during one routine Upper Endoscopy ]

Secondary Outcome Measures:
  • expression of miR in Barrett's esophagus patients with cancer in comparison to those who do not progress to cancer [ Time Frame: time it takes to have standard of care biopsies during one routine Upper Endoscopy ]

Biospecimen Retention:   Samples With DNA
biopsy tissue from proximal and distal esophagus, stomach and duodenum

Enrollment: 10
Study Start Date: April 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
No treatment
genetic research project; to meet inclusion criteria, participants must have normal upper GI tract upon upper endoscopy, for study biopsies to be taken

Detailed Description:

The incidence of esophageal adenocarcinoma has increased dramatically over the past three decades. These adenocarcinomas usually arise from columnar lined epithelium of the esophagus known as Barrett's esophagus (BE). There is an established association between gastroesophageal reflux disease (GERD) and the development of BE and esophageal adenocarcinoma. In an attempt to diagnose esophageal adenocarcinoma at an earlier and more treatable stage, efforts have been directed at identifying patients with BE and enrolling them in surveillance protocols. Several authors have challenged this strategy since it has not yet been proven to save lives and is very expensive. A major unresolved problem is the fact that the clinical factors considered to be somewhat predictive of the presence or absence of BE are neither sufficiently sensitive nor specific. In addition, once BE is identified, predicting who may or may not progress to cancer is far from perfect. A molecular understanding of why certain patients develop BE and why certain of those progress to cancer is of obvious importance.

The molecular pathway from normal esophageal mucosa to Barrett's esophagus and on to adenocarcinoma is not well understood. Micro-RNA (miR) RNAs have recently emerged as important regulators of carcinogenesis and have not been studied in BE. We seek to confirm our ability to characterize miR expression in various tissues (esophagus, stomach and duodenum) obtained from the upper gastrointestinal tract in preparation for the study of MiR in patients with Barrett's esophagus and other inflammatory conditions of the upper gastrointestinal tract.

This study will involve collection of tissue via endoscopic biopsy in 10 patients with normal endoscopic appearance from the esophagus, stomach and duodenum. Ambion miR oligonucleotide arrays will be utilized to profile miRs that are specifically expressed in epithelial biopsies from the duodenum, stomach, and esophagus. Total RNA will be extracted from independent biopsy samples using the mirVana(R) micro RNA isolation kit from Ambion. The Ambion Flash PAGE(R) electrophoresis system will be used to resolve mature miRs from the larger pre-miR species. Mature miRs will be labeled and hybridized to Ambion mirVana miR(R)arrays, which will be scanned to identify miRs that are regulated under these circumstances. Signals from the microarrays will be processed using the R functions of Bioconductor for normalization and background correction and RMA for summarization. Statistical significance will be determined using Insightful S+ functions and assuming a least pooled error model. Potential targets will be confirmed by northern blotting. The routine histology sample will be reviewed simply to exclude other, unexpected microscopic pathology. Benign histologic findings such as minor inflammation, will not exclude the patient from inclusion. If there is a wide variation in miR expression, then the histology might be needed to help explain such variation.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study subjects identified from individuals referred for upper endoscopy at Mayo Clinic in Jacksonville, Florida

Inclusion Criteria:

  • willingness to give consent
  • normal gross appearance of the esophagus, stomach and duodenum

Exclusion Criteria:

  • contraindication to mucosal biopsy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00909350

United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Kenneth R. DeVault,, M.D. Mayo Clinic, Jacksonville, Florida
  More Information

Responsible Party: Kenneth R. DeVault, M.D., Professor and Chair, Department of Medicine, Mayo Clinic, Jacksonville Florida, Mayo Clinic Identifier: NCT00909350     History of Changes
Other Study ID Numbers: 06-005272
Study First Received: May 27, 2009
Last Updated: February 11, 2015

Keywords provided by Kenneth R. DeVault, M.D., Mayo Clinic:
Barrett's esophagus
esophageal adenocarcinoma
miR expression

Additional relevant MeSH terms:
Barrett Esophagus
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms processed this record on May 25, 2017