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Trial record 19 of 57 for:    Recruiting, Not yet recruiting, Available Studies | "Colonic Polyps"

Endoscopic Characteristics of Colonic Tumours (C-LST)

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ClinicalTrials.gov Identifier: NCT01372696
Recruitment Status : Recruiting
First Posted : June 14, 2011
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

Brief Summary:
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 or disease Intervention/treatment Phase
Colonic Polyp Colon Cancer Other: Sample of polyp Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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

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

Information from the National Library of Medicine

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


Contacts
Contact: Michael Bourke 0298459779 westmeadendoscopyresearch@gmail.com
Contact: Rebecca Sonson 0298459779 ext 59779 bec2153@gmail.com

Locations
Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Michael Bourke    0298459779    westmeadendoscopyresearch@gmail.com   
Contact: Rebecca Sonson    0298459779    bec2153@gmail.com   
Sponsors and Collaborators
Professor Michael Bourke
Investigators
Principal Investigator: Michael Bourke Westmead Hospital - Endoscopy Unit

Responsible Party: Professor Michael Bourke, Dr Michael Bourke, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01372696     History of Changes
Other Study ID Numbers: LST-SGM
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical