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
Last Update Posted : November 11, 2016
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

Study Type : Observational
Actual Enrollment : 420 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

Primary Outcome Measures :
  1. The agreement rate between reads calculated over all selected features and pathologists. [ Time Frame: one day ]

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.

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

United States, Massachusetts
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Philips Digital & Computational Pathology
Study Director: Mischa Nelis Philips DPS

Responsible Party: Philips Digital & Computational Pathology Identifier: NCT02699970     History of Changes
Other Study ID Numbers: DPS-CT-0009
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016