Trial Review

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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/NCT02000141




Registration number
NCT02000141
Ethics application status
Date submitted
26/11/2013
Date registered
3/12/2013
Date last updated
29/06/2023

Titles & IDs
Public title
The Australian Colonic Advanced Mucosal Neoplasia and Endoscopic Resection Study
Scientific title
The Australian Colonic Advanced Mucosal Neoplasia and Endoscopic Resection Study - a Prospective Observational Cohort Study
Secondary ID [1] 0 0
AU RED HREC/13/WMEAD/233
Secondary ID [2] 0 0
HREC2013/8/4.5(3778)
Universal Trial Number (UTN)
Trial acronym
ACER/AMN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyps 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)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Endoscopic Mucosal Resection

Endoscopic Mucosal Resection - Endoscopic Mucosal Resection of Colonic Advanced Mucosal Lesions


Treatment: Surgery: Endoscopic Mucosal Resection
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence
Timepoint [1] 0 0
6-60 months
Secondary outcome [1] 0 0
Cancer prediction
Timepoint [1] 0 0
Initial procedure
Secondary outcome [2] 0 0
Improved Endoscopic Resection
Timepoint [2] 0 0
0-60 months

Eligibility
Key inclusion criteria
- Patients referred for endoscopic resection of a large sessile colonic polyp or
laterally spreading tumour =20mm in size.

- Age > 18 years

- Able to give informed consent to involvement in the clinical study
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to provide informed consent for involvement

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To enhance understanding of the risk factors for AMN, improve lesion assessment and
prediction of submucosal invasive cancer, improve endoscopic resection efficacy, reduce
complications of WF-EMR and improve the understanding of the progression of large lesions to
cancer
Trial website
https://clinicaltrials.gov/ct2/show/NCT02000141
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke, MBBS
Address 0 0
South West Sydney Area Health Service
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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 https://clinicaltrials.gov/ct2/show/NCT02000141