Instrument Precision Study for Validation of Philips Dx

Pathology Clinical Trial

Official title:

Instrument Precision Study for Validation of Philips Dx

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699970
• Other study ID #: DPS-CT-0009
• Status: Completed
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2019
• Source: Philips Digital & Computational Pathology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Pathology

Locations

Country	Name	City	State
United States	MGH	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Philips Digital & Computational Pathology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement Rate	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.	2 months