Trial Outcomes & Findings for Pivotal Study for Validation of Philips Dx (PDx) (NCT NCT02529137)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

2000 participants

Primary outcome timeframe

6 months

Results posted on

2021-05-28

Participant Flow

Case enrollment started in October 2015 and enrollment was completed in December 2015. A total of 2000 cases was enrolled. Eight cases were discontinued before reading, resulting in a total of 1992 cases for reading.

In total 2000 cases were planned to be enrolled, divided over the clinical study sites. A total of 2000 cases were enrolled, between 390 and 600 cases per site over four sites.

Participant milestones

Participant milestones
Measure	Surgical Pathology Cases Cases were selected from the sites Laboratory Information Systems using the in- and exclusion criteria. Each pathologist read the cases per block of 20 cases, alternating between Manual Optical and Manual Digital per block, i.e. all cases were evaluated by both modalities. At each site two pathologists were randomly assigned to the reading sequence starting with MO and two pathologists to the reading sequence starting with MD. There was no intervention in this study.
Overall Study STARTED	2000
Overall Study COMPLETED	1992
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Surgical Pathology Cases Cases were selected from the sites Laboratory Information Systems using the in- and exclusion criteria. Each pathologist read the cases per block of 20 cases, alternating between Manual Optical and Manual Digital per block, i.e. all cases were evaluated by both modalities. At each site two pathologists were randomly assigned to the reading sequence starting with MO and two pathologists to the reading sequence starting with MD. There was no intervention in this study.
Overall Study Discontinuation for different reasons	8

Baseline Characteristics

Pivotal Study for Validation of Philips Dx (PDx)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgical Pathology Cases n=1992 cases Cases were selected from the sites Laboratory Information Systems using the in- and exclusion criteria. Each pathologist read the cases per block of 20 cases, alternating between Manual Optical and Manual Digital per block, i.e. all cases were evaluated by both modalities. At each site two pathologists were randomly assigned to the reading sequence starting with MO and two pathologists to the reading sequence starting with MD. There was no intervention in this study.
Age, Categorical <=18 years	NA cases n=1992 cases
Age, Categorical Between 18 and 65 years	NA cases n=1992 cases
Age, Categorical >=65 years	NA cases n=1992 cases
Sex: Female, Male Female	NA cases n=1992 cases
Sex: Female, Male Male	NA cases n=1992 cases
Region of Enrollment United States	1992 cases n=1992 cases

PRIMARY outcome

Timeframe: 6 months

Population: 8 cases were discontinued for reasons such as broken/damaged slide (1), slide size did not meet the scanner specifications (4), no tissue detected by the scanner (2) and more than one case was selected for the patient (1).

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.

Outcome measures

Outcome measures
Measure	Manual Optical (MO) n=7961 Readings MO is defined as reading by using optical microscope. Reading results in a diagnosis. This diagnosis is later compared to the main diagnosis resulting in either concordance, minor discordance or major discordance.	Manual Digital (MD) n=7964 Readings MD is defined as reading by using PIPS. Reading results in a diagnosis. This diagnosis is later compared to the main diagnosis resulting in either concordance, minor discordance or major discordance.
Major Discordance Rate	4.4 percentage of major discordance Interval 3.02 to 6.33	4.7 percentage of major discordance Interval 3.27 to 6.82

Adverse Events

Surgical Pathology Cases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mischa Nelis, Clinical Study Director

Philips Digital Pathology Solutions

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60