Pathologic Processes
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Philips Digital & Computational Pathology
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Discordance Rate | 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2,000 |
| 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. | 1,992 |
| Total | 3,992 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discontinuation for different reasons | 8 |
Baseline characteristics
| Characteristic | Surgical Pathology Cases |
|---|---|
| Age, Categorical <=18 years | NA cases |
| Age, Categorical >=65 years | NA cases |
| Age, Categorical Between 18 and 65 years | NA cases |
| Region of Enrollment United States | 1992 cases |
| Sex: Female, Male Female | NA cases |
| Sex: Female, Male Male | NA cases |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2,000 |
| other Total, other adverse events | 0 / 2,000 |
| serious Total, serious adverse events | 0 / 2,000 |
Outcome results
Primary
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Manual Optical (MO) | Major Discordance Rate | 4.4 percentage of major discordance |
| Manual Digital (MD) | Major Discordance Rate | 4.7 percentage of major discordance |
95% CI: [-0.3, 1.01]