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Instrument Precision Study for Validation of Philips Dx

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02699970
Recruitment Status : Completed
First Posted : March 7, 2016
Results First Posted : November 1, 2019
Last Update Posted : November 1, 2019
Information provided by (Responsible Party):
Philips Digital & Computational Pathology

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

Condition or disease

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 399 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Instrument Precision Study for Validation of Philips Dx
Study Start Date : February 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

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.

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02699970

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United States, Massachusetts
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Philips Digital & Computational Pathology
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Study Director: Mischa Nelis Philips DPS
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Responsible Party: Philips Digital & Computational Pathology Identifier: NCT02699970    
Other Study ID Numbers: DPS-CT-0009
First Posted: March 7, 2016    Key Record Dates
Results First Posted: November 1, 2019
Last Update Posted: November 1, 2019
Last Verified: October 2019