Endoscopic Characteristics of Colonic Tumours

NCT ID: NCT01372696

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2019-06-03

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.

Conditions

Colonic Polyp; Colon Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Sample of polyp

Intervention Type: OTHER

A small sample of the colonic polyp will be obtained for molecular testing. The remaining polyp will be sent for regular histological testing

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Professor Michael Bourke

OTHER

Sponsor Role: lead

Responsible Party

Professor Michael Bourke

Dr Michael Bourke

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Bourke

Role: PRINCIPAL_INVESTIGATOR

Westmead Hospital - Endoscopy Unit

Locations

Westmead Hospital

Westmead, New South Wales, Australia

Countries

Australia

Other Identifiers

LST-SGM

Identifier Type: -

Identifier Source: org_study_id