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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Endoscopic Characteristics of Colonic Tumours
Scientific title
A Correlation of the Endoscopic Characteristics of Colonic LSTs With Their Somatic or Germline Mutations. A Prospective, Genome Wide Study
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyp 0 0
Colon Cancer 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Study type
Description of intervention(s) / exposure
Other interventions - Sample of polyp

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 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Samples will be looked at and stored for approx 15 years

Key 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
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Professor Michael Bourke

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Michael Bourke
Address 0 0
Westmead Hospital - Endoscopy Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael Bourke
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see