The primary objective is to generate genome-wide miRNA profiles of patient material (tissue samples and blood). The secondary objectives are to compare miRNA expression profiles to investigate what role differences in miRNA expression have in the…
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The patient part of the study will be finished when sufficient sample series
are collected for each group of patients. After this, the study will continue
without patient involvement and will consist of analyzing data from patient
material.
The primary objective is to generate genome-wide miRNA profiles of patient
material (tissue samples and blood).
Secondary outcome
The secondary objectives are to compare miRNA expression profiles to
investigate what role differences in miRNA expression have in the development
and malignant progression of Barrett's esophagus ( See research protocol p.
13).
Background summary
Barrett*s esophagus is a metaplastic response occurring in a minority of
patients with persistent gastro-esophageal reflux disease. Non-dysplastic
Barrett's esophagus can develop from inflamed squamous epithelium and progress
towards low-grade and subsequently high-grade dysplasia en eventually
esophageal adenocarcinoma, but only a small minority of Barrett's esophagus
patients will show malignant progression during their lifetime.
Efficient risk stratification methods to identify Barrett's esophagus patients
at risk for malignant progression are lacking due to an incomplete
understanding of the mechanisms underlying the development and malignant
progression of Barrett's esophagus. MicroRNAs (miRNAs), a class of small
regulatory RNA molecules, have been widely implicated in differentiation and
carcinogenesis. Currently, little is known regarding the role of miRNAs in
Barrett's esophagus, and this study is designed to study the biology of miRNAs
in Barrett's esophagus.
Study objective
The primary objective is to generate genome-wide miRNA profiles of patient
material (tissue samples and blood).
The secondary objectives are to compare miRNA expression profiles to
investigate what role differences in miRNA expression have in the development
and malignant progression of Barrett's esophagus.
Study design
The study is designed as a case control study, which will consist of five
patient groups.
Study burden and risks
The burden for the patient will consist of additional biopsies and one blood
sample taken during esophagogastroduodenoscopy sessions. The study does not
require additional esophagogastroduodenoscopy sessions, as an
esophagogastroduodenoscopy is performed for clinical reasons. The number of
site visits is thus unaltered by participation in the study. The number of
additional biopsies taken would approximately be six per patient (squamous
epithelium, non-dysplastic Barrett's esophagus and Barrett's esophagus with
high-grade dysplasia/early esophageal adenocarcinoma, all in twofold).
No significant risks are associated with the biopsy procedure itself; severe
bleeding or perforation of the esophagus are potential severe complications,
but occur very rarely. Taken the low risk of additional biopsies, the potential
knowledge that could be obtained by this study regarding prevention and
surveillance strategy outweighs the hazards associated with the study.
The collection of blood samples is a procedure that is routinely performed and
not associated with any serious complications in patients healthy enough to
undergo esophagogastroduodenoscopy. A hematoma may form at the puncture site,
but it will dissolve by itself within a few days.
Patients will be sent a short questionnaire along with the patient letter. The
questionnaire will consist of two questions, regarding smoking and medication
use.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
• 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36064.042.11 |