Clinical trial NCT02699970: Instrument Precision Study for Validation of Philips Dx
Official title: Instrument Precision Study for Validation of Philips Dx
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pathology
Lead sponsor: Philips Digital & Computational Pathology
Sponsor class: INDUSTRY
First posted: 2016-03-07
Enrollment: 399
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Agreement Rate
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH
state: Massachusetts
Study officials:
affiliation: Philips DPS
name: Mischa Nelis
role: STUDY_DIRECTOR
References: