Clinical trial NCT03991468: Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
Official title: Clinical Validation for Non-Inferiority of Primary Diagnosis by WSI Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Compared to Conventional Determination by Light Microscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pathology
Lead sponsor: Hamamatsu Photonics K.K.
Sponsor class: INDUSTRY
First posted: 2019-06-19
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cases are assessed using both glass slide light microscopy and NanoZoomer digital whole slide imaging in a random order
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.


Eligibility criteria: Inclusion Criteria:

* Cases originating from and that were diagnosed at that local site
* 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 does not have relevant slides or if case information necessary for the study is missing
* 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.

Primary outcomes:
measure: Major Discordance Rate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Albuquerque
country: United States
facility: TriCore Reference Laboratories
state: New Mexico
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Liron Pantanowitz
role: PRINCIPAL_INVESTIGATOR
References: