Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
Study NCT ID:
NCT03992768
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2019-06-18
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fujisaka@sys.hpk.co.jp', 'phone': '+81-53-435-1560', 'title': 'MCG Manager', 'organization': 'Hamamatsu Photonics, K.K.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Because there was no patient involvement in the study and no impact on patient diagnoses, there were no safety endpoints for the study', 'description': 'Because there was no patient involvement in the study and no impact on patient diagnoses, there were no safety endpoints for the study. Hence, there was no monitoring or assessment for adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'NanoZoomer Whole Slide Imaging', 'description': 'Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System\n\nHamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '540', 'groupId': 'OG000'}, {'value': '540', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}]}, {'units': 'Reads', 'counts': [{'value': '3402', 'groupId': 'OG000'}, {'value': '3402', 'groupId': 'OG001'}, {'value': '1134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NanoZoomer Whole Slide Imaging - Intra-scanner Precision', 'description': 'Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging'}, {'id': 'OG001', 'title': 'NanoZoomer Whole Slide Imaging - Inter-scanner Precision', 'description': 'Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging'}, {'id': 'OG002', 'title': 'NanoZoomer Whole Slide Imaging - Inter-site Precision', 'description': 'Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging'}], 'classes': [{'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000', 'lowerLimit': '93.7', 'upperLimit': '95.3'}, {'value': '92.4', 'groupId': 'OG001', 'lowerLimit': '90.7', 'upperLimit': '93.9'}, {'value': '93.4', 'groupId': 'OG002', 'lowerLimit': '91.9', 'upperLimit': '94.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Repeatability and reproducibility of WSI were evaluated using the Average Positive Agreement Rate. Using a comparison of two reads with four possible outcomes (a=both reads detect the feature; b=read 1 fails to detect the feature; c=read 2 fails to detect the feature; d=both reads fail to detect the feature), APA = 2a/(2a+b+c). APA was used to assess outcomes in the following substudies:\n\n1. Scans within scanner (Intra-scanner Precision): Scans are repeated within the scanner at the site.\n2. Scanners within site (Inter-scanner Precision): Scans are repeated among the scanners at the site\n3. Scans between Sites (Inter-site Precision): Scans are repeated within the scanner at the different sites.', 'unitOfMeasure': 'Average Positive Agreement Rate', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Reads', 'denomUnitsSelected': 'Reads', 'populationDescription': 'Intra-scanner Precision: 3 separate scans on 1 scanner of 378 features read by 3 reading pathologists in 3 sessions each Inter-scanner Precision: 1 scan each of 378 features on 3 scanners read by 3 reading pathologists in 3 sessions each Inter-site Precision: 378 FOVs scanned on 1 scanner read by 3 reading pathologists at 3 sites in 1 session each'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NanoZoomer Whole Slide Imaging', 'description': 'Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System\n\nHamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '540', 'numSubjects': '540'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '540', 'numSubjects': '540'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Features'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '540', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'NanoZoomer Whole Slide Imaging', 'description': 'Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System\n\nHamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'These data were not collected in this study.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Due to the fact that no subject-specific information was required for this study, no demographic information was collected.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'These data were not collected in this study.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Due to the fact that no subject-specific information was required for this study, no demographic information was collected.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '540', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '540', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-11', 'size': 3199893, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-27T17:25', 'hasProtocol': True}, {'date': '2021-10-08', 'size': 1779374, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-27T17:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 540}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-30', 'studyFirstSubmitDate': '2019-06-18', 'resultsFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2019-06-18', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-30', 'studyFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites.', 'timeFrame': '1 day', 'description': 'Repeatability and reproducibility of WSI were evaluated using the Average Positive Agreement Rate. Using a comparison of two reads with four possible outcomes (a=both reads detect the feature; b=read 1 fails to detect the feature; c=read 2 fails to detect the feature; d=both reads fail to detect the feature), APA = 2a/(2a+b+c). APA was used to assess outcomes in the following substudies:\n\n1. Scans within scanner (Intra-scanner Precision): Scans are repeated within the scanner at the site.\n2. Scanners within site (Inter-scanner Precision): Scans are repeated among the scanners at the site\n3. Scans between Sites (Inter-site Precision): Scans are repeated within the scanner at the different sites.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pathology']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging', 'detailedDescription': 'The study will be conducted under the following 3 sub-studies:\n\n1. Scans within Scanner (Intra-scanner precision substudy),\n2. Scanners within a site (Inter-scanner precision substudy),\n3. Scanners between sites (Inter-site precision substudy)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGlass slides are screened for the known features and will be considered eligible for the study only if all of the following criteria apply:\n\n* Slides are selected from cases in a consecutive manner starting with cases at least 1 year old since accessioning\n* Slide is a glass cover-slipped surgical pathology slide of human tissue\n* Slide is stained with hematoxylin and eosin (H\\&E) or other stains\n* Slide has the designated primary feature in the FOV, which is readily observable in its natural environment although the slide may also have one or more secondary features from the same magnification group in the FOV.\n* Slide is available in the archives for use, or purchased commercially, is not damaged, has tissue on the slide which is still in good condition, has a stain that is not faded and otherwise passes all quality checks\n\nExclusion Criteria:\n\nSlides are to be excluded from the study if any of the following criteria apply:\n\n* Slide is unable to be scanned, contains damaged tissue or has indelible markings\n* Slide comes from an active (less than 1 year old) case\n* Slide is from a patient who already has a slide enrolled in the study, only 1 slide per patient to be enrolled'}, 'identificationModule': {'nctId': 'NCT03992768', 'briefTitle': 'Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hamamatsu Photonics K.K.'}, 'officialTitle': 'Clinical Validation for Feature Detection Precision by WSI Using Hamamatsu NanoZoomer S360MD Digital Slide Scanner System', 'orgStudyIdInfo': {'id': 'HCT-P002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NanoZoomer Whole Slide Imaging', 'description': 'Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System', 'interventionNames': ['Device: Hamamatsu NanoZoomer S360MD Digital Slide Scanner System']}], 'interventions': [{'name': 'Hamamatsu NanoZoomer S360MD Digital Slide Scanner System', 'type': 'DEVICE', 'description': 'Detection of pathology features using whole slide imaging', 'armGroupLabels': ['NanoZoomer Whole Slide Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210-1063', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Anil Parwani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamamatsu Photonics K.K.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}