Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate precision of the Philips Dx system.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selected features | 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Cases will be selected from the LIS in consecutive order. Cases will be selected per feature and per organ. From these cases, slides will be selected containing the pre-specified study feature.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mischa Nelis | Philips DPS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH | Boston | Massachusetts | 02114 | United States |
Features were evenly distributed over three magnifications (10x, 20x or 40x). 21 different feature types were included. Each feature type was divided over three organs.
The study started enrollment in February 2016 and enrollment was completed in April 2016. The full set of 420 features were used for the intra-system study as well as for the inter-system sub-study.
| ID | Title | Description |
|---|---|---|
| FG000 | Precision | Intra-system: At one study site the slides with selected features were evenly distributed over three different systems. Each slide was scanned three times on the same system. All scans were read by all three pathologists. Inter-system: At one study site the full set of slides with selected features was scanned once on three different scanners. All three pathologists read all scans. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Features for intra-system sub-study were also used for inter-system sub-study. Baseline characteristics were not considered relevant and therefore not collected in this study.
| ID | Title | Description |
|---|---|---|
| BG000 | Precision | Intra-system: At one study site the slides with selected features were evenly distributed over three different systems. Each slide was scanned three times on the same system. All scans were read by all three pathologists. Inter-system: At one study site the full set of slides with selected features was scanned once on three different scanners. All three pathologists read all scans. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data were considered not relevant and therefore were not collected |
| 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 | 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. | For the intra-system sub-study 2 cases were not analyzed for possible reading bias due to an error in the EDC system. For the inter-system sub-study 3 cases were not analyzed for different reasons such as possible reading bias due to an error in the EDC system (2) and a short washout period (1). | Posted | Mean | 95% Confidence Interval | percentage of agreement | 2 months | features | features |
|
From study start to study closure (8 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Precision | Intra-system sub-study: At one study site the slides with selected features were evenly distributed over three different systems. Each slide was scanned three times on the same system. All scans were read by all three pathologists. Inter-system sub-study: At one study site the full set of slides with selected features was scanned once on three different scanners. All three pathologists read all scans. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mischa Nelis, Clinical Study Director | Philips Digital Pathology Solutions | dpsclinicaltrials@philips.com |
Not provided
Not provided
Not provided
Not provided
| features |
|
| Count of Participants |
| Participants |
| Participants |
|
|
| Sex: Female, Male | Data were considered not relevant and therefore were not collected | Count of Units | features | features |
|
|
| Region of Enrollment | Number | Study features | Participants |
|
|
| OG001 | Inter-system Sub-study | At one study site the full set of slides with selected features was scanned once on three different scanners. All three pathologists read all scans. |
|
|
| 0 |
| 399 |
| 0 |
| 399 |
| 0 |
| 399 |
Not provided