Trial Outcomes & Findings for Instrument Precision Study for Validation of Philips Dx (NCT NCT02699970)
NCT ID: NCT02699970
Last Updated: 2019-11-01
Results Overview
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.
COMPLETED
399 participants
2 months
2019-11-01
Participant Flow
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.
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.
Unit of analysis: feature
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
399 420
|
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Overall Study
Intra-system
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399 420
|
|
Overall Study
Inter-system
|
399 420
|
|
Overall Study
COMPLETED
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399 420
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Instrument Precision Study for Validation of Philips Dx
Baseline characteristics by cohort
| Measure |
Precision
n=420 features
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.
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|---|---|
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Region of Enrollment
United States
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420 Study features
n=399 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: 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).
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.
Outcome measures
| Measure |
Intra-system Sub-study
n=418 features
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
n=417 features
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.
|
|---|---|---|
|
Agreement Rate
|
92.0 percentage of agreement
Interval 90.57 to 93.29
|
93.8 percentage of agreement
Interval 92.56 to 94.98
|
Adverse Events
Precision
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60