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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colonic Polyp, Colon Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Significant differences in molecular abnormalities.

Outcome 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.

Outcome Time Frame:

Samples will be looked at and stored for approx 15 years

Safety Issue:

No

Principal Investigator

Michael Bourke

Investigator Role:

Principal Investigator

Investigator Affiliation:

Westmead Hospital - Endoscopy Unit

Authority:

Australia: National Health and Medical Research Council

Study ID:

LST-SGM

NCT ID:

NCT01372696

Start Date:

November 2009

Completion Date:

December 2016

Related Keywords:

  • Colonic Polyp
  • Colon Cancer
  • Colonic Neoplasms
  • Colonic Polyps

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