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CompletedNCT00909350Updated Feb 12, 2015

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

An observational study in Barrett's Esophagus and Esophageal Adenocarcinoma, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-12.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Barrett's Esophagus
  • Esophageal Adenocarcinoma

Keywords

  • Barrett's esophagus
  • BE
  • esophageal adenocarcinoma
  • Micro-RNA
  • miR expression
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 10 is below the median of 153 across 332 observational studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • contraindication to mucosal biopsy
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

07

Study locations

1 site
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00909350
Lead sponsor
Mayo Clinic
Responsible party
Kenneth R. DeVault, M.D. (Professor and Chair, Department of Medicine, Mayo Clinic, Jacksonville Florida, Mayo Clinic) — Principal investigator
First posted
May 28, 2009
Start date
Apr 2008
Primary completion
Nov 2008
Completion
Nov 2008
Last update
Feb 12, 2015

Study contacts

Kenneth R. DeVault,, M.D.
principal investigator · Mayo Clinic, Jacksonville, Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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