Endoscopic Characteristics of Colonic Tumours

Not Applicable

Withdrawn

• Conditions: Colon Cancer; Colonic Polyp
• Interventions: Other: Sample of polyp

• Registration Number: NCT01372696
• Lead Sponsor: Professor Michael Bourke

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.

Study Timeline

• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Study Start: 2019-06-03
• Primary Completion: 2019-06-03
• Study Completion: 2019-06-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tissue sample	Sample of polyp	Patients who consent to participate in this study will have a small sample of their polyp and normal tissue sent for molecular testing.

Primary Outcome Measures

Name	Time	Method
Significant differences in molecular abnormalities.	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.

Trial Locations

Locations (1)

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia