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

NCT00909350 | Completed

• 1 other identifier: 06-005272
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Barrett's Esophagus; Esophageal Adenocarcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• miR expression between tissue from Barrett's esophagus and that from normal tissues

  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 it takes to have standard of care biopsies during one routine Upper Endoscopy

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects identified from individuals referred for upper endoscopy at Mayo Clinic in Jacksonville, Florida

You may qualify if:

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

You may not qualify if:

• contraindication to mucosal biopsy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

biopsy tissue from proximal and distal esophagus, stomach and duodenum

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Kenneth R. DeVault,, M.D.

  Mayo Clinic, Jacksonville, Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Medicine, Mayo Clinic, Jacksonville Florida

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: May 28, 2009
• Study Start: April 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

US (1)