Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-04 @ 9:16 AM
Study NCT ID:
NCT02617992
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2015-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systematic Wide-Field EMR Scar Assessment and Therapy Audit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011127', 'term': 'Polyps'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2015-11-08', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of post-EMR recurrence', 'timeFrame': 'one year', 'description': 'Presence of post-EMR recurrence'}], 'secondaryOutcomes': [{'measure': 'Histological characteristics of post-EMR scar biopsies', 'timeFrame': 'one year'}, {'measure': 'Scar size', 'timeFrame': 'one year', 'description': 'Scar size (maximum dimension)'}, {'measure': 'Presence of post EMR scar with clip artifact', 'timeFrame': 'one year', 'description': 'Presence of post EMR scar with clip artifact, recognized as one or more nodule within the scar with a normal pit pattern'}, {'measure': 'Number of sites of recurrence', 'timeFrame': 'one year', 'description': 'Number of sites of recurrence (unifocal, 2 sites, 3 or more sites)'}, {'measure': 'Location of recurrence', 'timeFrame': 'one year', 'description': 'Location of recurrence (edge of the scar, within the scar or both)'}, {'measure': 'Morphology of recurrence', 'timeFrame': 'one year', 'description': 'Morphology of recurrence (flat or elevated)'}, {'measure': 'Kudo pit pattern assessment', 'timeFrame': 'one year', 'description': 'Kudo pit pattern and whether the pit pattern of recurrence is only seen with NBI'}, {'measure': 'NICE classification', 'timeFrame': 'one year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Polyps']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Removal of colonic polyps reduces colon cancer and although most polyps found are small, removal of large polyps can now be safely and effectively removed with wide field EMR. Residual polyp tissue is found at follow up colonoscopy in approximately 15% of cases however and remains a focus of attempts to improve EMR efficacy. All patients undergoing surveillance colonoscopy after EMR at Westmead Hospital Endoscopy unit will have steps of assessment and therapy of the scar recorded. Data will be entered into the large prospective audit database and also analysed separately. Data will be stored in coded format. The individual steps and the outcome of the scar interrogation and therapy will also be assessed and analysed. It is expected that these results will help guide the optimal approach to assessment and confirm the efficacy of therapy of recurrence further aiding the endoscopic approach to large colonic polyps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have had endoscopic mucosal resection of colonic polyps that are undergoing surveillance colonoscopy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing surveillance colonoscopy of a previously resected large sessile colonic polyp or laterally spreading tumour ≥20mm in size.\n* Age \\> 18 years\n* Able to give informed consent to involvement in the clinical study\n\nExclusion Criteria:\n\n* Unable to provide informed consent for involvement'}, 'identificationModule': {'nctId': 'NCT02617992', 'acronym': 'SANT', 'briefTitle': 'Systematic Wide-Field EMR Scar Assessment and Therapy Audit', 'organization': {'class': 'OTHER', 'fullName': 'Western Sydney Local Health District'}, 'officialTitle': 'Systematic Wide-Field EMR Scar Assessment and Therapy Audit', 'orgStudyIdInfo': {'id': 'HREC2013/8/6.5 (3796)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EMR Surveillance', 'description': 'Patients who are referred for Endoscopic Mucosal Resection of Upper Gastrointestinal Lesions undertaking a surveillance visit will be included in this cohort.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}], 'overallOfficials': [{'name': 'Michael Bourke, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Sydney Local Health District'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Sydney Local Health District', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Gastrointestinal Endoscopy', 'investigatorFullName': 'Professor Michael Bourke', 'investigatorAffiliation': 'Western Sydney Local Health District'}}}}