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

2015年2月11日 更新者:Kenneth R. DeVault, M.D.、Mayo Clinic

Micro-RNA (miR) Expression in Upper Gastrointestinal Mucosal Tissue: A Potential Target for Understanding and Preventing the Progression of Barrett's Esophagus

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.

研究概览

地位

完全的

详细说明

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.

研究类型

观察性的

注册 (实际的)

10

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Florida
      • Jacksonville、Florida、美国、32224
        • Mayo Clinic

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindication to mucosal biopsy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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

研究衡量的是什么?

主要结果指标

结果测量
大体时间
miR expression between tissue from Barrett's esophagus and that from normal tissues
大体时间:time it takes to have standard of care biopsies taken during one routine Upper Endoscopy
time it takes to have standard of care biopsies taken during one routine Upper Endoscopy

次要结果测量

结果测量
大体时间
expression of miR in Barrett's esophagus patients with cancer in comparison to those who do not progress to cancer
大体时间:time it takes to have standard of care biopsies during one routine Upper Endoscopy
time it takes to have standard of care biopsies during one routine Upper Endoscopy

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Kenneth R. DeVault,, M.D.、Mayo Clinic, Jacksonville, Florida

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年4月1日

初级完成 (实际的)

2008年11月1日

研究完成 (实际的)

2008年11月1日

研究注册日期

首次提交

2009年5月27日

首先提交符合 QC 标准的

2009年5月27日

首次发布 (估计)

2009年5月28日

研究记录更新

最后更新发布 (估计)

2015年2月12日

上次提交的符合 QC 标准的更新

2015年2月11日

最后验证

2015年2月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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