Endoscopic Characteristics of Colonic Tumours

Colon Cancer Clinical Trial

— C-LST  

Official title:

A Correlation of the Endoscopic Characteristics of Colonic LSTs With Their Somatic or Germline Mutations. A Prospective, Genome Wide Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01372696
• Other study ID #: LST-SGM
• Status: Withdrawn
• Phase: N/A
• Start date: November 2009
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Polyp
• Colonic Polyps

Intervention

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

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Professor Michael Bourke

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Samples will be looked at and stored for approx 15 years