Endoscopic Characteristics of Colonic Tumours (C-LST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01372696|
Recruitment Status : Recruiting
First Posted : June 14, 2011
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colonic Polyp Colon Cancer||Other: Sample of polyp||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Correlation of the Endoscopic Characteristics of Colonic LSTs With Their Somatic or Germline Mutations. A Prospective, Genome Wide Study|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
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
- Significant differences in molecular abnormalities. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|