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Instrument Precision Study for Validation of Philips Dx

2019年10月9日 更新者:Philips Digital & Computational Pathology
The objective of this study is to evaluate precision of the Philips Dx system.

研究概览

地位

完全的

条件

详细说明

Slides were selected that contained clinically relevant histopathologic "features" that are generally encountered on surgical pathology slides. Twenty-one features, each selected from three different organs, were to be included to ensure that multiple tissue types were investigated. The study feature(s) as selected on each slide was defined as the "selected feature". In total 420 selected features were acquired and the slides holding these features composed the "slide set". The slideset consisted of 399 slides from 399 different participants.

  1. Intra-system study. The full slide set was then divided over three subsets. Each subset was then scanned three times on one systems, with each subset being scanned on a different scanner. This means that each feature was scanned three times. Each of three pathologists read all three scans of the entire slide set. Intra-system precision was thereby determined.
  2. Inter-system study. The full slide set was then scanned three times, each time on a different system, meaning that each feature was scanned three times. Each of three pathologists (different pathologists the ones used in the intra-system study) read all three scans of the entire slide set. Inter-system precision was thereby determined.

研究类型

观察性的

注册 (实际的)

399

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • MGH

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Cases will be selected from the LIS in consecutive order. Cases will be selected per feature and per organ. From these cases, slides will be selected containing the pre-specified study feature.

描述

Inclusion Criteria:

  • Left-over specimens from subjects who already received their diagnosis and have received their treatment in accordance with the standard of care
  • H&E glass coverslipped slides with human tissue obtained via surgical pathology
  • Selected slides fulfill the quality checks according to the Instructions for Use (lfU)
  • Selected slides must be between 1-5 years since accessioning
  • Selected slides and FOVs must contain a study feature that is: In it's natural environment (on slide and FOV); Readily observable (on slide and FOV); Not equivocal (on slide and FOV).

Exclusion Criteria:

  • Selected slides contain indelible markings
  • Selected slides contain damaged tissue
  • More than one slide was selected for a patient (only one slide may be enrolled per patient).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Selected features

No intervention is administered to the selected features. They only need to be observed by the pathologist.

The features are part of tissue that is present on a slide. This slide is fully scanned and the digital image is than viewed by the pathologist who indicates if he can see the feature. By repeating the scan three times and having the pathologist view three times, the consistency of the feedback can be monitored. The consistency is a measure on how repeatable and reproducible the scanner is. To be very clear: the scanner does not do anything to the tissue. It only takes a digital 'photo' of the tissue. It is no treatment or intervention. It just takes a picture.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Agreement Rate
大体时间:2 months
The agreement rate between reads calculated over all selected features and pathologists. Readings were considered in agreement when the selected feature was indicated as 'present' or 'absent' in both readings.
2 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Mischa Nelis、Philips DPS

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年2月1日

初级完成 (实际的)

2016年9月1日

研究完成 (实际的)

2016年10月1日

研究注册日期

首次提交

2016年3月1日

首先提交符合 QC 标准的

2016年3月1日

首次发布 (估计)

2016年3月7日

研究记录更新

最后更新发布 (实际的)

2019年11月1日

上次提交的符合 QC 标准的更新

2019年10月9日

最后验证

2019年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • DPS-CT-0009

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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