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临床试验/NCT01372696
NCT01372696撤回不适用

A Correlation of the Endoscopic Characteristics of Colonic LSTs With Their Somatic or Germline Mutations. A Prospective, Genome Wide Study

Professor Michael Bourke2 个研究点 分布在 1 个国家开始时间: 2019年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
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 colonoscopy, 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 colon 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, colon cancer is in fact a heterogenous disease forming via multiple distinct genetic pathways. Additionally, with improved endoscopic characterization, it has been noted from experience at Westmead hospital that two macroscopically distinct types of LSTs, "granular" and "non granular", have different natural histories and risks of invasive cancer. 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 colonoscopy 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 colonoscopy frequency. This is an area with interest currently due to the national bowel cancer screening programme, with obvious cost implications for decision makers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Intention to perform Endoscopic Mucosal Resection
  • Polyp 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: Samples will be looked at and stored for approx 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

Dr Michael Bourke

Western Sydney Local Health District

研究点 (2)

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