PathologyNCT02699970
Instrument Precision Study for Validation of Philips Dx
An observational study of Pathology, run by Philips Digital & Computational Pathology at 1 site in United States.
Trial summary
The objective of this study is to evaluate precision of the Philips Dx system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pathology
- How many people
- 399 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Left-over specimens from subjects who already received their diagnosis and have received their treatment in accordance with the standard of care
- H\&E glass coverslipped slides with human tissue obtained via surgical pathology
- Selected slides fulfill the quality checks according to the Instructions for Use (lfU)
- Selected slides must be between 1-5 years since accessioning
- Selected slides and FOVs must contain a study feature that is: In it's natural environment (on slide and FOV); Readily observable (on slide and FOV); Not equivocal (on slide and FOV).
Who cannot join
- Selected slides contain indelible markings
- Selected slides contain damaged tissue
- More than one slide was selected for a patient (only one slide may be enrolled per patient).
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate precision of the Philips Dx system.
Read the detailed description
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.
- Intra-system study. The full slide set was then divided over three subsets. Each subset was then scanned three times on one systems, with each subset being scanned on a different scanner. This means that each feature was scanned three times. Each of three pathologists read all three scans of the entire slide set. Intra-system precision was thereby determined.
- Inter-system study. The full slide set was then scanned three times, each time on a different system, meaning that each feature was scanned three times. Each of three pathologists (different pathologists the ones used in the intra-system study) read all three scans of the entire slide set. Inter-system precision was thereby determined.
- Conditions
- Pathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Digital & Computational Pathology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mischa Nelis, Study director, Philips DPS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699970
- Sponsor's protocol ID
- DPS-CT-0009
- Status last verified
- Oct 2019
- First submitted
- 1 Mar 2016
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrument Precision Study for Validation of Philips Dx
- ClinicalTrials.gov ID
- NCT02699970
- Acronym / sponsor ID
- DPS-CT-0009
- Conditions
- Pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Philips Digital & Computational PathologyIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Posted 1 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate precision of the Philips Dx system.
Detailed description
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.
- Intra-system study. The full slide set was then divided over three subsets. Each subset was then scanned three times on one systems, with each subset being scanned on a different scanner. This means that each feature was scanned three times. Each of three pathologists read all three scans of the entire slide set. Intra-system precision was thereby determined.
- Inter-system study. The full slide set was then scanned three times, each time on a different system, meaning that each feature was scanned three times. Each of three pathologists (different pathologists the ones used in the intra-system study) read all three scans of the entire slide set. Inter-system precision was thereby determined.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Left-over specimens from subjects who already received their diagnosis and have received their treatment in accordance with the standard of care
- H\&E glass coverslipped slides with human tissue obtained via surgical pathology
- Selected slides fulfill the quality checks according to the Instructions for Use (lfU)
- Selected slides must be between 1-5 years since accessioning
- Selected slides and FOVs must contain a study feature that is: In it's natural environment (on slide and FOV); Readily observable (on slide and FOV); Not equivocal (on slide and FOV).
Key exclusion criteria (3 listed)
- Selected slides contain indelible markings
- Selected slides contain damaged tissue
- More than one slide was selected for a patient (only one slide may be enrolled per patient).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement Rate
Time frame: 2 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mischa Nelis study director
Philips DPS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathology, run by Philips Digital & Computational Pathology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Rate (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019; AzTrials last refreshed its copy on 30 Oct 2026.