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Completed

NCT Number: NCT02699970

Instrument Precision Study for Validation of Philips Dx

The objective of this study is to evaluate precision of the Philips Dx system.

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Key information

Conditions

Pathology

Sex eligibility

All sexes

Study type

Observational

Primary location

MGH

Boston, Massachusetts, 02114, United States

About this study

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.

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Agreement Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Philips Digital & Computational Pathology

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 7, 2016
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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