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The role of miRNAs in the biology of Barrett*s esophagus

The role of miRNAs in the biology of Barrett*s esophagus - The role of miRNAs in the biology of Barrett*s esophagus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39347
Enrollment
70
Registered
2011-07-08
Start date
2012-05-13
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barret's esophagus

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)