PathologyNCT04879056
Instrument Precision Study for Validation of PIPS 5.1
An observational study of Pathology, run by Philips Digital & Computational Pathology at 1 site in United States.
Trial summary
This study is designed to evaluate the instrument precision of the device for its proposed intended use in sub-studies: intra-system and inter-system. The precision within a system will be evaluated on three systems by three pathologists at one site. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Pathology
- What is being tested?
- PIPS 5.1
- How many people
- 399 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 20 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year and older
- All sexes
- Child, Adult, Older adult
Study population: Study features are selected on glass slides from consecutive cases from the laboratory information system.
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 IfU
- Selected slides must be at least one year since accessioning
- Selected slides and FOVs must contain a study feature that is:
- In it's natural environment (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.
United States1 site, 1 recruiting
- Recruiting
Capital Choice Pathology Laboratory
Silver Spring, Maryland, 20904
Cacciabeve, Dr.
About this study
This study is designed to evaluate the instrument precision of the device for its proposed intended use in sub-studies: intra-system and inter-system. The precision within a system will be evaluated on three systems by three pathologists at one site. Specific features will be selected on glass slides, which will then be scanned. On the whole slide images field of views will be created including the features. In the reading phase three pathologists will read the field of views and record which features they observe.
Read the detailed description
This study is designed to evaluate the instrument precision of the device for its proposed intended use in sub-studies: intra-system and inter-system. Each sub-study will have three phases: enrollment, preparation and reading.
Per sub-study the precision of the device will be based on three reading pathologists' assessments and identification of specific clinically relevant histopathologic "features" that are encountered in formalin-fixed, paraffin-embedded (FFPE) hematoxylin and eosin (H\&E) slides. Examples of these features are eosinophils, plasma cells, goblet cells, foreign body giant cells, etc. Three magnifications are used in this study: 10x, 20x and 40x. These magnifications represent the magnifications typically used in routine clinical practice. There will be seven different study features per magnification. In total twenty-one features will be selected, with each feature selected from at least three different organs, to ensure that multiple tissue types are investigated.
Precision will be assessed in sub-studies: intra-system and inter-system.
- In the intra-system study the precision within a system will be evaluated on three systems by three pathologists at one site;
- In the inter-system study the precision between systems will be evaluated on three systems by three pathologists at one site;
Enrollment:
The enrollment process (case selection, slide selection, feature selection, and field of view (FOV) selection) will be performed by an enrollment pathologist (EP), a validating enrollment pathologist (VEP) and a study technician.
Cases will be selected from the laboratory information system (LIS) by the EP. For each pre-specified study feature and organ, consecutive cases will be selected per feature. From these cases, slides will be selected containing the pre-specified study feature(s) for which the EP is searching at that moment. The study feature(s) on the chosen slide is/are then called the "selected feature(s)". The VEP confirms if the selected feature(s) is/are present on the glass slide. The validated slides are scanned by a study technician for enrollment. The EP reviews the whole slide image (WSI) of the slide and defines an area (bookmark) containing the selected feature(s) at the appropriate magnification. The sponsor will create a static full resolution extraction image of the bookmark, which will then be defined as the FOV. The VEP confirms if the feature(s) is/are present on the FOV. Note that the precise flow may be adapted according site preference with the pre-requisite that all slides and FOVs are selected and validated before enrolment. After confirmation, the FOV is considered enrolled.
Scanning and reading:
After enrollment the slides are scanned by the study technician for the reading sessions. The sponsor extracts the FOV(s) from each image, identical to the enrollment FOV. Scanning and reading will be different per sub-study, see below.
The reading pathologists in this study will be blinded to certain details in the protocol e.g. the study features.
The reading pathologist will review the FOV as a snapshot with no panning or zooming capabilities. The reading pathologist will assess the presence of each of the features on a feature checklist appropriate for that particular magnification.
Scanning and reading intra-system study:
The study slide set will be equally (n=133 slides per system) and randomly divided over three systems at one site. On each system the slides are scanned three times with at least six hours of system downtime (ensuring full cool down) between scanning iterations.
Three separate reading sessions will be performed by each of three reading pathologists, with a washout period of at least two weeks between individual sessions.
Each reading pathologist will read all study FOVs from all three iterations and all three systems in a randomized way.
Scanning and reading inter-system study:
The complete study slide set (n=399) will be scanned once on each of the three systems at one site. Three separate reading sessions will be performed by each of the three pathologists with a washout period of at least two weeks between individual sessions. Each reading pathologist will read all study FOVs in a randomized way.
- Conditions
- Pathology
- Being tested
- PIPS 5.1
- Keywords
- WSI, features
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPS 5.1Diagnostic test
Description: Scanning glass slides on PIPS 5.1. This intervention will be applied in the arm of intra-system and the arm of inter-system.
| Study group | Role | What they receive |
|---|---|---|
| intra-system | reviewing selected features on images from three iterations of the same scanner. Receives: Diagnostic Test: PIPS 5.1 | |
| inter-system | reviewing selected features on images from three different scanners. Receives: Diagnostic Test: PIPS 5.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of features
Each reading pathologist will record the presence of listed features on the checklist. The results will be used for deriving an agreement rate between repeated readings from the same reading pathologist over all enrolled (i.e. selected and validated) features.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start20 May 2021
- Primary completion20 Aug 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 399 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Digital & Computational Pathology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mischa Nelis, MsC, Study director, Philips Digital & Computational Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879056
- Sponsor's protocol ID
- 10254
- Status last verified
- May 2022
- First submitted
- 25 Jan 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrument Precision Study for Validation of PIPS 5.1
- ClinicalTrials.gov ID
- NCT04879056
- Acronym / sponsor ID
- 10254
- Conditions
- Pathology
- Keywords
- WSI, features
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 399 participants (estimated)
- Lead sponsor
- Philips Digital & Computational PathologyIndustry (pharma, biotech, devices)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 Aug 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the instrument precision of the device for its proposed intended use in sub-studies: intra-system and inter-system. The precision within a system will be evaluated on three systems by three pathologists at one site. Specific features will be selected on glass slides, which will then be scanned. On the whole slide images field of views will be created including the features. In the reading phase three pathologists will read the field of views and record which features they observe.
Detailed description
This study is designed to evaluate the instrument precision of the device for its proposed intended use in sub-studies: intra-system and inter-system. Each sub-study will have three phases: enrollment, preparation and reading.
Per sub-study the precision of the device will be based on three reading pathologists' assessments and identification of specific clinically relevant histopathologic "features" that are encountered in formalin-fixed, paraffin-embedded (FFPE) hematoxylin and eosin (H\&E) slides. Examples of these features are eosinophils, plasma cells, goblet cells, foreign body giant cells, etc. Three magnifications are used in this study: 10x, 20x and 40x. These magnifications represent the magnifications typically used in routine clinical practice. There will be seven different study features per magnification. In total twenty-one features will be selected, with each feature selected from at least three different organs, to ensure that multiple tissue types are investigated.
Precision will be assessed in sub-studies: intra-system and inter-system.
- In the intra-system study the precision within a system will be evaluated on three systems by three pathologists at one site;
- In the inter-system study the precision between systems will be evaluated on three systems by three pathologists at one site;
Enrollment:
The enrollment process (case selection, slide selection, feature selection, and field of view (FOV) selection) will be performed by an enrollment pathologist (EP), a validating enrollment pathologist (VEP) and a study technician.
Cases will be selected from the laboratory information system (LIS) by the EP. For each pre-specified study feature and organ, consecutive cases will be selected per feature. From these cases, slides will be selected containing the pre-specified study feature(s) for which the EP is searching at that moment. The study feature(s) on the chosen slide is/are then called the "selected feature(s)". The VEP confirms if the selected feature(s) is/are present on the glass slide. The validated slides are scanned by a study technician for enrollment. The EP reviews the whole slide image (WSI) of the slide and defines an area (bookmark) containing the selected feature(s) at the appropriate magnification. The sponsor will create a static full resolution extraction image of the bookmark, which will then be defined as the FOV. The VEP confirms if the feature(s) is/are present on the FOV. Note that the precise flow may be adapted according site preference with the pre-requisite that all slides and FOVs are selected and validated before enrolment. After confirmation, the FOV is considered enrolled.
Scanning and reading:
After enrollment the slides are scanned by the study technician for the reading sessions. The sponsor extracts the FOV(s) from each image, identical to the enrollment FOV. Scanning and reading will be different per sub-study, see below.
The reading pathologists in this study will be blinded to certain details in the protocol e.g. the study features.
The reading pathologist will review the FOV as a snapshot with no panning or zooming capabilities. The reading pathologist will assess the presence of each of the features on a feature checklist appropriate for that particular magnification.
Scanning and reading intra-system study:
The study slide set will be equally (n=133 slides per system) and randomly divided over three systems at one site. On each system the slides are scanned three times with at least six hours of system downtime (ensuring full cool down) between scanning iterations.
Three separate reading sessions will be performed by each of three reading pathologists, with a washout period of at least two weeks between individual sessions.
Each reading pathologist will read all study FOVs from all three iterations and all three systems in a randomized way.
Scanning and reading inter-system study:
The complete study slide set (n=399) will be scanned once on each of the three systems at one site. Three separate reading sessions will be performed by each of the three pathologists with a washout period of at least two weeks between individual sessions. Each reading pathologist will read all study FOVs in a randomized way.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intra-system | – | Diagnostic Test: PIPS 5.1reviewing selected features on images from three iterations of the same scanner. |
| inter-system | – | Diagnostic Test: PIPS 5.1reviewing selected features on images from three different scanners. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Study features are selected on glass slides from consecutive cases from the laboratory information system.
Key inclusion criteria (7 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 IfU
- Selected slides must be at least one year since accessioning
- Selected slides and FOVs must contain a study feature that is:
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIPS 5.1Description: Scanning glass slides on PIPS 5.1. This intervention will be applied in the arm of intra-system and the arm of inter-system. | Diagnostic test | inter-system, intra-system |
Primary outcome
Presence or absence of features
Time frame: 1 day
Each reading pathologist will record the presence of listed features on the checklist. The results will be used for deriving an agreement rate between repeated readings from the same reading pathologist over all enrolled (i.e. selected and validated) features.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
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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, MsC study director
Philips Digital & Computational Pathology
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 7 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: status not confirmed, as of the sponsor's last update on 19 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Desiree van Neerven, MsC (+31646410548, desiree.van.neerven@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of features (time frame: 1 day). 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 19 May 2022.