Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-02-11 @ 6:10 AM
Study NCT ID:
NCT03991468
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2019-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Primary Diagnosis 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'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D008853', 'term': 'Microscopy'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, '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. Therefore no adverse event assessment or monitoring took place.', 'eventGroups': [{'id': 'EG000', 'title': 'All Cases', 'description': 'All cases were assessed via Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides and traditional light microscopy using glass slides. The order in which each modality is used was randomly assigned.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Major Discordance Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'OG000'}, {'value': '2000', 'groupId': 'OG001'}]}, {'units': 'Reads', 'counts': [{'value': '7997', 'groupId': 'OG000'}, {'value': '7998', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NanoZoomer Whole Slide Imaging', 'description': 'Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides\n\nWhole Slide Imaging: Scanning of a glass slide to create a digital image that can be viewed on a monitor'}, {'id': 'OG001', 'title': 'Glass Slide Light Microscopy', 'description': 'Use of a traditional light microscope to assess pathological characteristics of glass slides\n\nLight Microscopy: Use of traditional light microscopy per institutional standard practice'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '4.7'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '4.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Dependent var = major discordance status (yes/no); independent var = modality (WSI/Glass) as a fixed effect \\& site, reader, \\& case as random effects.', 'nonInferiorityComment': 'A Mixed Model Repeated Measures logistic regression was used to prove WSI major discordance (MD) rate non-inferior to Glass MD rate. A two-sided 95% CI for the difference in MD rate was constructed. If the upper bound of the 95% CI was less than the non-inferiority margin of 4%, then WSI would be considered non-inferior to Glass, assuming power = 0.9 and alpha = 0.05 a sample size of 2000 was calculated to be sufficient to prove non-inferiority.'}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Indpendent reads by four Reading Pathologists (RPs) of both imaging modalitites (8 reads/case) were compared to the original diagnosis ("ground truth" or GT) by an independent adjudication process. This resulted in one of four adjudication outcomes for each read: "Match" (read = GT), "Minor" (minor discordance between read \\& GT), "Major" (major discordance between read \\& GT), or "Deferred" (read deferred by RP and excluded from the primary endpoint analysis). The outcome measure was the rate at which major discordances occurred for each modality.', 'unitOfMeasure': 'Percentage of Major Discordances', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Reads', 'denomUnitsSelected': 'Reads', 'populationDescription': 'Two modalities (glass \\& WSI) are read by 4 reading pathologists at each site for a total of 16,000 reads. Any reads deferred by a reading pathologist are excluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Cases', 'description': 'All cases will be assessed via Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides and traditional light microscopy using glass slides. The order in which each modality is used will be randomly assigned.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2000'}]}, {'type': 'Glass Slide Light Microscopy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2000'}]}, {'type': 'NanoZoomer Whole Slide Imaging', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2000'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2000'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Cases were assessed using both glass slide light microscopy and digital whole slide imaging in a random sequence. Therefore, each case had 2 primary diagnoses in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Cases', 'description': 'All cases were assessed via Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides and traditional light microscopy using glass slides. The order in which each modality is used was randomly assigned.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.6', 'spread': '14.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2000', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1046', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '954', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'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': '2000', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2000', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-09', 'size': 2790699, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-27T17:21', 'hasProtocol': True}, {'date': '2021-08-01', 'size': 775517, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-30T15:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Adjudicators are blinded to the imaging modality.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Cases are assessed using both glass slide light microscopy and NanoZoomer digital whole slide imaging in a random order'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-07-31', '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': '2019-06-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Discordance Rate', 'timeFrame': '1 day', 'description': 'Indpendent reads by four Reading Pathologists (RPs) of both imaging modalitites (8 reads/case) were compared to the original diagnosis ("ground truth" or GT) by an independent adjudication process. This resulted in one of four adjudication outcomes for each read: "Match" (read = GT), "Minor" (minor discordance between read \\& GT), "Major" (major discordance between read \\& GT), or "Deferred" (read deferred by RP and excluded from the primary endpoint analysis). The outcome measure was the rate at which major discordances occurred for each modality.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pathology']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and accuracy of the Hamamatsu WSI compared to those of the reference method (conventional light microscope (Glass)) under clinical use conditions as an aid for pathologists to view, review and diagnose digital images of surgical pathology slides.\n\nThe primary endpoint is the indicator of major discordance in primary diagnosis between ground truth case diagnosis and case diagnosis by each modality, WSI and Glass, separately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cases originating from and that were diagnosed at that local site\n* Cases are available in the site's archive\n* Cases are at least 1 year old since accessioning\n* Cases are selected because their primary diagnosis is consistent with the assigned target categories\n* Cases have a set of slides representative of the primary diagnosis for which it has been selected\n\nSlide selection for a given case must meet the following criteria:\n\n* Slide is obtained by surgical pathology and prepared from FFPE human tissue\n* Slides must be stained with H\\&E and accompanying special stains (histochemical and/or immunohistochemical)\n* All special stains slides (histochemical and/or immunohistochemical) where the slide and stain is used for diagnosis, not prognosis.\n* A chosen slide must demonstrate and be representative of the primary diagnosis; 1 slide selection may suffice for biopsy cases,\n* For resection cases, a minimum of 5 slides must be selected, which represent the primary diagnosis. If represented with less than 5 slides, additional slides (primary, secondary, or benign slides) from same case may be used to fulfill minimum number\n* Slide is intact, has correct size/thickness, good edges, undamaged coverslip, without pen markings that can't be removed, no air bubbles, tidy labels, and fulfills the quality checks per the general clinical practice\n\nExclusion Criteria:\n\n* Case does not have relevant slides or if case information necessary for the study is missing\n* Case is still active (less than 1 year old) at the local site\n* Cases for which the control slides for immunohistochemistry and special stains are not available\n* Two cases from same individual\n* Gross-only cases that have no slides\n* Cases that are frozen section, cytology or hematology or immunofluorescence specimens only\n* Case where the only available set of slides have evidence only of secondary or no diagnoses and not the primary diagnosis for which the case is being screened.\n\nSlides for a given case will be excluded if they meet the following criterion:\n\n• Glass slide that is broken, has abnormal size/thickness, beveled edges, poor coverslip (cracks, waviness, scratches), is sticky, has many pen markings or dirt that cannot be removed, contains air bubbles and overhanging labels that can't be corrected, and if stain is severely faded."}, 'identificationModule': {'nctId': 'NCT03991468', 'briefTitle': 'Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hamamatsu Photonics K.K.'}, 'officialTitle': 'Clinical Validation for Non-Inferiority of Primary Diagnosis by WSI Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Compared to Conventional Determination by Light Microscope', 'orgStudyIdInfo': {'id': 'HCT-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NanoZoomer Whole Slide Imaging', 'description': 'All cases will be assessed via Whole Slide Imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System to assess pathological characteristics of scanned slides.', 'interventionNames': ['Diagnostic Test: Whole Slide Imaging']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glass Slide Light Microscopy', 'description': 'All cases will be assessed via the use of traditional light microscopy to assess pathological characteristics of glass slides.', 'interventionNames': ['Diagnostic Test: Light Microscopy']}], 'interventions': [{'name': 'Whole Slide Imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['NanoZoomer Scanning & Imaging'], 'description': 'Scanning of a glass slide to create a digital image that can be viewed on a monitor', 'armGroupLabels': ['NanoZoomer Whole Slide Imaging']}, {'name': 'Light Microscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Use of traditional light microscopy per institutional standard practice', 'armGroupLabels': ['Glass Slide Light Microscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'TriCore Reference Laboratories', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'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': 'Liron Pantanowitz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamamatsu Photonics K.K.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}