A Correlation of the Endoscopic Characteristics of Duodenal and Ampullary Laterally Spreading Tumours With Their Somatic or Germline Mutations.
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
- 否
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
Professor Michael Bourke
Director of Gastrointestinal Endoscopy
Western Sydney Local Health District
