Clinical Validation for Feature Detection Precision by WSI Using Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 6
- 主要终点
- Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites.
研究概览
简要总结
The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging
详细描述
The study will be conducted under the following 3 sub-studies:
- Scans within Scanner (Intra-scanner precision substudy),
- Scanners within a site (Inter-scanner precision substudy),
- Scanners between sites (Inter-site precision substudy)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glass slides are screened for the known features and will be considered eligible for the study only if all of the following criteria apply:
- •Slides are selected from cases in a consecutive manner starting with cases at least 1 year old since accessioning
- •Slide is a glass cover-slipped surgical pathology slide of human tissue
- •Slide is stained with hematoxylin and eosin (H&E) or other stains
- •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.
- •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
排除标准
- •Slides are to be excluded from the study if any of the following criteria apply:
- •Slide is unable to be scanned, contains damaged tissue or has indelible markings
- •Slide comes from an active (less than 1 year old) case
- •Slide is from a patient who already has a slide enrolled in the study, only 1 slide per patient to be enrolled
结局指标
主要结局
Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites.
时间窗: 1 day
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. Scans within scanner (Intra-scanner Precision): Scans are repeated within the scanner at the site. 2. Scanners within site (Inter-scanner Precision): Scans are repeated among the scanners at the site 3. Scans between Sites (Inter-site Precision): Scans are repeated within the scanner at the different sites.
次要结局
未报告次要终点