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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical pathology cases | Cases will be selected from the sites Laboratory Information Systems using the in- and exclusion criteria. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria
Exclusion Criteria
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Both: surgical pathology slides of both female and male participants are being studied.
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| Name | Affiliation | Role |
|---|---|---|
| Mischa Nelis | Philips DPS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shady Grove Adventist | Silver Spring | Maryland | 20904 | United States | ||
| Cleveland Clinic |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Surgical pathology cases where diagnosis was already rendered for more than one year before start of study
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Units |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Number | 95% Confidence Interval | percentage of major discordance | 6 months | Readings | Readings |
|
From study start to study closure (11 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mischa Nelis, Clinical Study Director | Philips Digital Pathology Solutions | dpsclinicaltrials@philips.com |
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| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Cleveland |
| Ohio |
| 44195 |
| United States |
| Miraca Life Sciences | Irving | Texas | 75039 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| cases |
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| cases |
| cases |
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| Sex: Female, Male | Count of Units | cases | No | cases |
|
| Region of Enrollment | Number | cases | cases |
|
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.
| OG001 | Manual Digital (MD) | 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. |
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|
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| 0 |
| 2,000 |
| 0 |
| 2,000 |
| 0 |
| 2,000 |
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