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The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging
The study will be conducted under the following 3 sub-studies:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoZoomer Whole Slide Imaging | Experimental | Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hamamatsu NanoZoomer S360MD Digital Slide Scanner System | Device | Detection of pathology features using whole slide imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites. | 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:
| 1 day |
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Inclusion Criteria:
Glass slides are screened for the known features and will be considered eligible for the study only if all of the following criteria apply:
Exclusion Criteria:
Slides are to be excluded from the study if any of the following criteria apply:
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| Name | Affiliation | Role |
|---|---|---|
| Anil Parwani, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States | ||
| The Cleveland Clinic Foundation |
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| ID | Title | Description |
|---|---|---|
| FG000 | NanoZoomer Whole Slide Imaging | Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NanoZoomer Whole Slide Imaging | Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | These data were not collected in this study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites. | 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:
| 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 | Posted | Number | 95% Confidence Interval | Average Positive Agreement Rate | 1 day | Reads | Reads |
Because there was no patient involvement in the study and no impact on patient diagnoses, there were no safety endpoints for the study
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NanoZoomer Whole Slide Imaging | Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MCG Manager | Hamamatsu Photonics, K.K. | +81-53-435-1560 | fujisaka@sys.hpk.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2020 | Oct 27, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 8, 2021 | Oct 27, 2022 | SAP_001.pdf |
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| Cleveland |
| Ohio |
| 44195 |
| United States |
| The Ohio State University | Columbus | Ohio | 43210-1063 | United States |
Due to the fact that no subject-specific information was required for this study, no demographic information was collected.
| Count of Participants |
| Participants |
| No |
|
| Sex: Female, Male | These data were not collected in this study. | Due to the fact that no subject-specific information was required for this study, no demographic information was collected. | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | NanoZoomer Whole Slide Imaging - Intra-scanner Precision | Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging |
| OG001 | NanoZoomer Whole Slide Imaging - Inter-scanner Precision | Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging |
| OG002 | NanoZoomer Whole Slide Imaging - Inter-site Precision | Hamamatsu NanoZoomer S360MD Digital Slide Scanner System: Detection of pathology features using whole slide imaging |
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