Instrument Precision Study for Validation of Philips Dx

Philips

Status: Completed

Conditions: Pathology

Study type: Observational

Funder types: Industry

Identifiers

NCT02699970

DPS-CT-0009

Details and patient eligibility

About

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

Full 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.

Enrollment: 399 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

399 participants in 1 patient group

Selected features

Description:

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.