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临床试验/NCT01556399
NCT01556399已完成不适用

A Correlation of the Endoscopic Characteristics of Duodenal and Ampullary Laterally Spreading Tumours With Their Somatic or Germline Mutations.

Professor Michael Bourke1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
350
试验地点
1
主要终点
Significant differences in molecular abnormalities.

研究概览

简要总结

The purpose is to investigate whether polyps that look different at endoscopy, have formed via different mutations and have different risks of turning into cancer.

详细描述

Laterally spreading tumours (LSTs), are polyps that have a lateral extension along the duodenal wall with minimal vertical growth. It has become evident over the last few years that rather than being a single entity requiring an accumulation of mutations, Duodenal and ampullary cancer is in fact a heterogenous disease forming via multiple distinct genetic pathways. It is therefore hypothesised that different polyp types have different genetic abnormalities, and potentially form via distinct genetic pathways, although this theory has not been widely examined.

This knowledge would be important in furthering our understanding of the development of cancer. There is accumulating evidence that genetic abnormalities may be a better predictor of cancer behaviour than histological grade. Additionally, guidelines for endoscopy surveillance are currently a one size fits all approach that do not reflect the genetic heterogeneity of the disease and the knowledge that only 5% of polyps progress to cancer. Genetic studies may assess future cancer risk to a person in polyps once removed and plan surveillance endoscopy frequency.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intention to perform Endoscopic Mucosal Resection
  • Adenoma equal to or greater than 20mm
  • over 18 years of age
  • Able to give informed consent to involvement in trial

排除标准

  • Pregnancy
  • Lactation: currently breastfeeding
  • Taken clopidogrel within 7 days
  • Taken warfarin within 5 days
  • Had full therapeutic dose unfractionated heparin within 6 hours
  • Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
  • Known clotting disorder

结局指标

主要结局

Significant differences in molecular abnormalities.

时间窗: Specimens will be stored and used for up to 15 years

The aim of this project is to look for statistically significant differences in molecular abnormalities from the three known genetic pathways, between the two different morphological types, granular and non-granular, to potentially demonstrate that these different polyps form via different genetic pathways.

次要结局

未报告次要终点

研究者

发起方
Professor Michael Bourke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Professor Michael Bourke

Director of Gastrointestinal Endoscopy

Western Sydney Local Health District

研究点 (1)

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