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WithdrawnNCT01372696C-LSTUpdated Mar 27, 2025

Endoscopic Characteristics of Colonic Tumours

An interventional study of Sample of polyp in Colonic Polyp and Colon Cancer, sponsored by Professor Michael Bourke. Withdrawn at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Professor Michael Bourke · Not applicable, Interventional, and Other

Why this study was withdrawn
study abandoned
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colonic Polyp
  • Colon Cancer

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03

In context

Colonic Polyps

318 studies on the registry are indexed under Colonic Polyps; 54 are open to participants now.

Browse Colonic Polyps studies →

Lead sponsor

Professor Michael Bourke is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    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.

    Other: Sample of polyp

Interventions

  • OtherSample 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Samples will be looked at and stored for approx 15 years

07

Study locations

1 site
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01372696
Lead sponsor
Professor Michael Bourke
Responsible party
Professor Michael Bourke (Dr Michael Bourke, Western Sydney Local Health District) — Sponsor-investigator
First posted
Jun 14, 2011
Start date
Jun 3, 2019
Primary completion
Jun 3, 2019
Completion
Jun 3, 2019
Last update
Mar 27, 2025

Study contacts

Michael Bourke
principal investigator · Westmead Hospital - Endoscopy Unit

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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