Endoscopic Characteristics of Colonic Tumours (Colonic LST)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Correlation of the Endoscopic Characteristics of Colonic LSTs With Their Somatic or Germline Mutations. A Prospective, Genome Wide Study|
- Significant differences in molecular abnormalities. [ Time Frame: Samples will be looked at and stored for approx 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.
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Patients who consent to participate in this study will have a small sample of their polyp and normal tissue sent for molecular testing.
Other: Sample of polyp
A small sample of the colonic polyp will be obtained for molecular testing. The remaining polyp will be sent for regular histological testing
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372696
|Contact: Michael Bourkeemail@example.com|
|Contact: Rebecca Sonson||0298459779 ext firstname.lastname@example.org|
|Australia, New South Wales|
|Westmead, New South Wales, Australia, 2145|
|Contact: Michael Bourke 0298459779 email@example.com|
|Contact: Rebecca Sonson 0298459779 firstname.lastname@example.org|
|Principal Investigator:||Michael Bourke||Westmead Hospital - Endoscopy Unit|