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Endoscopic Characteristics of Colonic Tumours (C-LST)

This study is currently recruiting participants.
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Verified December 2015 by Professor Michael Bourke, Western Sydney Local Health District
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District Identifier:
First received: June 9, 2011
Last updated: December 15, 2015
Last verified: December 2015
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.

Condition Intervention
Colonic Polyp Colon Cancer Other: Sample of polyp

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Professor Michael Bourke, Western Sydney Local Health District:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 350
Study Start Date: November 2009
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tissue sample
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

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01372696

Contact: Michael Bourke 0298459779
Contact: Rebecca Sonson 0298459779 ext 59779

Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Michael Bourke    0298459779   
Contact: Rebecca Sonson    0298459779   
Sponsors and Collaborators
Professor Michael Bourke
Principal Investigator: Michael Bourke Westmead Hospital - Endoscopy Unit
  More Information

Responsible Party: Professor Michael Bourke, Dr Michael Bourke, Western Sydney Local Health District Identifier: NCT01372696     History of Changes
Other Study ID Numbers: LST-SGM
Study First Received: June 9, 2011
Last Updated: December 15, 2015

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Pathological Conditions, Anatomical processed this record on September 21, 2017