The role of miRNAs in the biology of Barrett*s esophagus
- Conditions
- Barret's esophagus1001793410017991
- Registration Number
- NL-OMON39347
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
For the group with advanced esophageal adenocarcinoma > stage 1A :
• Patients older than 18 years with esophageal adenocarinoma with stage 1B or higher that are scheduled for esophagogastroduodenoscopy.
For the high-grade dysplasia or esophageal adenocarcinoma group:
• Patients older than 18 years with Barrett's esophagus and esophageal adenocarinoma until stage 1A (established on the basis of a histological biopsy) that are scheduled for esophagogastroduodenoscopy.
For the non-dysplastic Barrett's esophagus group:
• Patients older than 18 years with long-standing non-dysplastic Barrett's esophagus that are under surveillance and have not shown any signs of malignant progression.
For the gastro-esophgeal reflux disease group patients:
• Patients older than 18 years without Barrett's esophagus but with reflux disease, confirmed by an esophagogastroduodenoscopy
For the control group patients:
• Patients older than 18 years without Barrett's esophagus or reflux disease, confirmed by an esophagogastroduodenoscopy
• Patients younger than 18 years
• Patients unfit to undergo esophagogastroduodenoscopy.
• Patients in whom no samples of either squamous epithelium, Barrett's esophagus or esophageal adenocarcinoma epithelium could be obtained for different reasons, as judged by the endoscopist
• For the gastro-esophgeal reflux disease group patients: the presence of Barrett's esophagus
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The patient part of the study will be finished when sufficient sample series<br /><br>are collected for each group of patients. After this, the study will continue<br /><br>without patient involvement and will consist of analyzing data from patient<br /><br>material.<br /><br><br /><br>The primary objective is to generate genome-wide miRNA profiles of patient<br /><br>material (tissue samples and blood). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are to compare miRNA expression profiles to<br /><br>investigate what role differences in miRNA expression have in the development<br /><br>and malignant progression of Barrett's esophagus ( See research protocol p.<br /><br>13).</p><br>