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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02617992
Registration number
NCT02617992
Ethics application status
Date submitted
8/11/2015
Date registered
1/12/2015
Date last updated
23/03/2021
Titles & IDs
Public title
Systematic Wide-Field EMR Scar Assessment and Therapy Audit
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Scientific title
Systematic Wide-Field EMR Scar Assessment and Therapy Audit
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Secondary ID [1]
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HREC2013/8/6.5 (3796)
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Universal Trial Number (UTN)
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Trial acronym
SANT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Polyps
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Condition category
Condition code
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
EMR Surveillance - Patients who are referred for Endoscopic Mucosal Resection of Upper Gastrointestinal Lesions undertaking a surveillance visit will be included in this cohort.
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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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Presence of post-EMR recurrence
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Assessment method [1]
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Presence of post-EMR recurrence
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Timepoint [1]
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one year
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Secondary outcome [1]
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Histological characteristics of post-EMR scar biopsies
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Assessment method [1]
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0
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Timepoint [1]
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one year
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Secondary outcome [2]
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Scar size
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Assessment method [2]
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Scar size (maximum dimension)
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Timepoint [2]
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one year
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Secondary outcome [3]
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Presence of post EMR scar with clip artifact
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Assessment method [3]
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Presence of post EMR scar with clip artifact, recognized as one or more nodule within the scar with a normal pit pattern
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Timepoint [3]
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one year
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Secondary outcome [4]
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Number of sites of recurrence
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Assessment method [4]
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Number of sites of recurrence (unifocal, 2 sites, 3 or more sites)
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Timepoint [4]
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one year
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Secondary outcome [5]
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Location of recurrence
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Assessment method [5]
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Location of recurrence (edge of the scar, within the scar or both)
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Timepoint [5]
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one year
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Secondary outcome [6]
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Morphology of recurrence
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Assessment method [6]
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Morphology of recurrence (flat or elevated)
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Timepoint [6]
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one year
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Secondary outcome [7]
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Kudo pit pattern assessment
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Assessment method [7]
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Kudo pit pattern and whether the pit pattern of recurrence is only seen with NBI
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Timepoint [7]
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one year
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Secondary outcome [8]
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NICE classification
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Assessment method [8]
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As recurrence is diminutive the NICE classification is also applied and so the NBI appearance of recurrence (darker or lighter than the scar) is noted.
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Timepoint [8]
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one year
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Eligibility
Key inclusion criteria
* Patients undergoing surveillance colonoscopy of a previously resected 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
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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
* Unable to provide informed consent for involvement
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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
Completed
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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
1/09/2013
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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
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Actual
1/09/2015
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Sample size
Target
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Accrual to date
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Final
200
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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
Western Sydney Local Health District
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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
The development of a standardised imaging protocol to detect post endoscopic mucosal resection (EMR) recurrence or residual adenoma through the comparison of biopsies of the post EMR scar with endoscopic findings.
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Trial website
https://clinicaltrials.gov/study/NCT02617992
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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, MBBS
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Address
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Western Sydney Local Health District
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02617992
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