Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
NCT ID: NCT03991468
Last Updated: 2022-12-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
2000 participants
INTERVENTIONAL
2019-03-15
2021-07-31
Brief Summary
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The 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
SINGLE
Study Groups
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NanoZoomer Whole Slide Imaging
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.
Whole Slide Imaging
Scanning of a glass slide to create a digital image that can be viewed on a monitor
Glass Slide Light Microscopy
All cases will be assessed via the use of traditional light microscopy to assess pathological characteristics of glass slides.
Light Microscopy
Use of traditional light microscopy per institutional standard practice
Interventions
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Whole Slide Imaging
Scanning of a glass slide to create a digital image that can be viewed on a monitor
Light Microscopy
Use of traditional light microscopy per institutional standard practice
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cases are available in the site's archive
* Cases are at least 1 year old since accessioning
* Cases are selected because their primary diagnosis is consistent with the assigned target categories
* Cases have a set of slides representative of the primary diagnosis for which it has been selected
Slide selection for a given case must meet the following criteria:
* Slide is obtained by surgical pathology and prepared from FFPE human tissue
* Slides must be stained with H\&E and accompanying special stains (histochemical and/or immunohistochemical)
* All special stains slides (histochemical and/or immunohistochemical) where the slide and stain is used for diagnosis, not prognosis.
* A chosen slide must demonstrate and be representative of the primary diagnosis; 1 slide selection may suffice for biopsy cases,
* 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
* 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
Exclusion Criteria
* Case is still active (less than 1 year old) at the local site
* Cases for which the control slides for immunohistochemistry and special stains are not available
* Two cases from same individual
* Gross-only cases that have no slides
* Cases that are frozen section, cytology or hematology or immunofluorescence specimens only
* 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.
Slides for a given case will be excluded if they meet the following criterion:
• 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.
ALL
No
Sponsors
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Hamamatsu Photonics K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Liron Pantanowitz
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center
Locations
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Washington University
St Louis, Missouri, United States
TriCore Reference Laboratories
Albuquerque, New Mexico, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HCT-P001
Identifier Type: -
Identifier Source: org_study_id