Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2026-01-22 @ 8:28 AM
Study NCT ID:
NCT04032912
Status:
COMPLETED
Last Update Posted:
2021-03-24
First Post:
2019-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Non-Optical Resect and Discard Study (NORD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-20', 'studyFirstSubmitDate': '2019-07-04', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examine concordance with the pathology-based surveillance recommendation of two new resect and discard models', 'timeFrame': '24 months', 'description': 'Our aim is to examine and to make a comparison of these models with the currently endorsed resect and discard approach that is based on optical polyp diagnosis and we will also obtain histopathology for all polyps as a reference gold-standard to which all models are compared.'}], 'secondaryOutcomes': [{'measure': 'Assess for how many patients each model will theoretically reduce the need for histopathologic assessment and follow-up consultations to discuss pathology results and surveillance interval recommendations', 'timeFrame': '24 months', 'description': 'Assess for how many patients each model will theoretically reduce the need for histopathologic assessment and follow-up consultations to discuss pathology results and surveillance interval recommendations'}, {'measure': 'Re-evaluate classical optical biopsy criteria (NICE and SANO classifications)', 'timeFrame': '24 months', 'description': 'We will assess this in conjunction with different digital chromoendoscopy methods (NBI, iScan and Optivista) and assess concordance between these imaging methods and classification systems to differentiate neoplastic from non-neoplastic polyps.'}, {'measure': 'Assess which factors are associated with accuracy and negative predictive value (NPV) of optical polyp diagnosis', 'timeFrame': '24 months', 'description': 'Assess which factors are associated with accuracy and negative predictive value (NPV) of optical polyp diagnosis'}, {'measure': 'Evaluate Polyp-Based Resect and Discard model', 'timeFrame': '24 months', 'description': 'Surveillance interval agreement of the PBRD strategy compared with pathology-based management according to the 2020 USMSTF guidelines.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polyp resection', 'Colorectal cancer'], 'conditions': ['Polyp of Colon']}, 'referencesModule': {'references': [{'pmid': '34448185', 'type': 'DERIVED', 'citation': 'Taghiakbari M, Pohl H, Djinbachian R, Barkun A, Marques P, Bouin M, Deslandres E, Panzini B, Bouchard S, Weber A, von Renteln D. The location-based resect and discard strategy for diminutive colorectal polyps: a prospective clinical study. Endoscopy. 2022 Apr;54(4):354-363. doi: 10.1055/a-1546-9169. Epub 2021 Aug 26.'}]}, 'descriptionModule': {'briefSummary': 'Eliminating the need for conventional histopathological assessment of diminutive colon polyps - The Non-Optical Resect and Discard (NORD) study', 'detailedDescription': 'Implementation of this approach by community-based gastroenterologists has failed to reach the required quality benchmarks and studies evaluating optical biopsy have not shown diagnostic test performance results that meet standards set by society guidelines in order to promote its widespread clinical adoption. Optical polyp diagnosis and the current resect and discard approach are too complex for clinical adoption. Thus, clinical implementation of this valuable concept has not been achieved to date and its cost-saving potential has not been realized. In order to effectively operationalize a resect and discard strategy, one must find a different way to distinguish neoplastic from non-neoplastic polyps. There exist differences in the proportion of polyps found to be adenomatous in the left and right colon. One recent study reported that 30% of left-sided polyps and 76% of right-sided polyps were found to be adenomas on histology. Since polyps located in the proximal colon are more likely to be adenomas and polyps in the recto-sigmoid colon are more likely hyperplastic we hypothesized that a model based on polyp location might be able to replace optical biopsy and histopathology. Such an approach would be very simple to adopt by every clinician and would allow for easy adoption into clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All 45-80 year old patients scheduled for an elective colonoscopy with the potential of a polyp removal will be considered for the study. This includes patients hospitalized that do not require an emergency colonoscopy (defined as colonoscopy in the emergency or intensive care unit or patients with active upper or lower gastrointestinal bleeding). Potential study subjects are approached to participate: 1) during an outpatient clinic; 2) at their arrival at the endoscopy clinic on the day of the colonoscopy; or 3) on the hospital ward (for patients hospitalized).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form\n* Age 45 to 80 years\n* Indication for full colonoscopy\n\nExclusion Criteria:\n\n* Known inflammatory bowel disease\n* Active colitis\n* Coagulopathy\n* Familial polyposis syndrome\n* Poor general health defined as an ASA class \\> 3\n* Emergency colonoscopies.'}, 'identificationModule': {'nctId': 'NCT04032912', 'acronym': 'NORD', 'briefTitle': 'The Non-Optical Resect and Discard Study (NORD)', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Eliminating the Need for Conventional Histopathological Assessment of Diminutive Colon Polyps - The Non-Optical Resect and Discard Study (NORD)', 'orgStudyIdInfo': {'id': '16.367'}}, 'armsInterventionsModule': {'interventions': [{'name': 'iScan', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Optivista'], 'description': 'this instrument provides extra confidence for in vivo diagnosis through improved vessel and mucosal pattern characterization.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Montréal (CHUM)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Daniel von Renteln, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}