Endoscopic Characteristics of Duodenal and Ampullary Lesions (DUO/AMP-LST)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Correlation of the Endoscopic Characteristics of Duodenal and Ampullary Laterally Spreading Tumours With Their Somatic or Germline Mutations.|
- Significant differences in molecular abnormalities. [ Time Frame: Specimens will be stored and used for up to 15 years ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Adenoma tissue sample and control "regular" tissue sample
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Patients who consent to participate in this study will have a small sample of their adenoma and normal tissue sent for molecular testing.
Other: Tissue Sampling
A small sample of the duodenal adenoma will be obtained for molecular testing. The remaining adenoma will be sent for regular histological testing.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556399
|Contact: Michael Bourke, MBBS, FRACPfirstname.lastname@example.org|
|Contact: Rebecca Sonson, BMemail@example.com|
|Australia, New South Wales|
|Westmead, New South Wales, Australia, 2145|
|Contact: Michael Bourke, MBBS, FRACP 0409042019 firstname.lastname@example.org|
|Contact: Rebecca Sonson, BN 98459779 email@example.com|
|Principal Investigator:||Michael Bourke, MBBS, FRACP||Western Sydney Local Health District|