Pivotal Study for Validation of Philips Dx (PDx)

Pivotal Study for Validation of Philips Dx for Diagnosis in Surgical Pathology

The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.

Study Overview

• Status: Completed
• Conditions: Pathologic Processes

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Silver Spring, Maryland, United States, 20904
      • Shady Grove Adventist
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Texas
    • Irving, Texas, United States, 75039
      • Miraca Life Sciences
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Both: surgical pathology slides of both female and male participants are being studied.

Description

Inclusion Criteria

• All relevant coverslipped slide or slides, with human tissue obtained via surgical pathology of original case are available.
• Original sign-out diagnosis is available.
• The selected slide or slides fulfill the quality checks according to general clinical practice.
• Target enrollment of organs and subtypes according pre-specified list.

Exclusion Criteria

• Cases, including sent out cases, for which any of the relevant slides used for the original sign-out diagnosis is no longer available at the site.
• The selected slide or slides do not match any subtype of the organ for which the case was selected.
• Relevant Clinical Information that was available to the sign-out pathologist in the pathology request form cannot be obtained.
• Selected slides contain indelible markings.
• Selected slides with damaged tissue.
• More than one case was selected for a patient (only one case may be enrolled per patient).
• Case consists of frozen section(s) only.
• Case consists of gross specimens only.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Surgical pathology cases; Cases will be selected from the sites Laboratory Information Systems using the in- and exclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Discordance Rate	The primary endpoint was the difference in major discordance rates between Manual Optical (MO) and Manual Digital (MD). MO is defined as reading by using optical microscope whereas MD is defined as reading by using PIPS. MO major discordance rate is defined as the proportion of major discordances between the MO diagnosis and the main diagnosis from the total number of readings. MD major discordance rate is defined as the proportion of major discordances between the MD diagnosis and the main diagnosis from the total number of readings.	6 months

Collaborators and Investigators

• Sponsor: Philips Digital & Computational Pathology
• Investigators: Study Director: Mischa Nelis, Philips DPS

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 20, 2015

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes
• Other Study ID Numbers: DPS-CT-0007