Endoscopic Characteristics of Colonic Tumours (C-LST)
Primary Purpose
Colonic Polyp, Colon Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Sample of polyp
Sponsored by

About this trial
This is an interventional other trial for Colonic Polyp
Eligibility 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
Sites / Locations
- Westmead Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Tissue sample
Arm Description
Patients who consent to participate in this study will have a small sample of their polyp and normal tissue sent for molecular testing.
Outcomes
Primary Outcome Measures
Significant differences in molecular abnormalities.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01372696
Brief Title
Endoscopic Characteristics of Colonic Tumours
Acronym
C-LST
Official Title
A Correlation of the Endoscopic Characteristics of Colonic LSTs With Their Somatic or Germline Mutations. A Prospective, Genome Wide Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Professor Michael Bourke
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp, Colon Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tissue sample
Arm Type
Other
Arm Description
Patients who consent to participate in this study will have a small sample of their polyp and normal tissue sent for molecular testing.
Intervention Type
Other
Intervention Name(s)
Sample of polyp
Intervention Description
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 Measure Information:
Title
Significant differences in molecular abnormalities.
Description
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.
Time Frame
Samples will be looked at and stored for approx 15 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bourke
Organizational Affiliation
Westmead Hospital - Endoscopy Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Characteristics of Colonic Tumours
We'll reach out to this number within 24 hrs