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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01368289
Registration number
NCT01368289
Ethics application status
Date submitted
6/06/2011
Date registered
7/06/2011
Date last updated
3/07/2023
Titles & IDs
Public title
Australian Multicentre Colonic Endoscopic Mucosal Resection Study
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Scientific title
Australian Multicentre Colonic Endoscopic Mucosal Resection (ACE/EMR) Study
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Secondary ID [1]
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ACE/EMR
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Universal Trial Number (UTN)
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Trial acronym
ACEEMR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colonic Polyps
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - Endoscopic Mucosal Resection
Colonic Polyps - Patients who present with colonic polyps >20mm
Treatment: Surgery: Endoscopic Mucosal Resection
Endoscopic Mucosal Resection of large sessile colonic polyps.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Technical success for Endoscopic resection
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Assessment method [1]
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To determine the safety, efficacy and predictors of success for Endoscopic Mucosal Resection of large sessile colorectal polyps. The utility of endoscopic criteria to stratify for the risk of Submucosal Invasive Cancer was also assessed.
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Timepoint [1]
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6-60 months
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Eligibility
Key inclusion criteria
- Large sessile polyp (equal to or greater than 20mm)
- Intention to perform EMR
- Aged 18 years or older
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Colonic polyps less than 20mm
- Aged younger then 18 years.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
3072
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Funding & Sponsors
Primary sponsor type
Other
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Name
Professor Michael Bourke
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A prospective, multicentre, observational study of all patients referred for endoscopic
resection of sessile colorectal polyps sized =20 mm conducted with intention to treat
analysis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01368289
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael Bourke
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Address
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Westmead Hospital - Endoscopy Unit
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01368289
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