Pathological ProcessesNCT07881874
This Study is the Clinical Validation Study for Validation for the Digital Pathology System 'SGi 1.0 + EPW 1.0 + Compatible Clinical Displays'
An observational study of Pathological Processes, run by Philips Digital & Computational Pathology at 2 sites in United States.
Trial summary
The primary objective of this study is to show safety and effectiveness of the investigational device for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pathological Processes
- What is being tested?
- Digital pathology system
- How many people
- 470 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2026to 15 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Child, Adult, Older adult
Study population: Surgical Pathology cases are selected according pre-specified list consisting of consecutive cases from the archive with pre-specified organs and subtypes.
Who may be able to join
- All hematoxylin and eosin (H\&E), immunohistochemistry (IHC) and special stains glass coverslipped slide or slides, with human tissue obtained via surgical pathology of original case are available;
- Original sign-out diagnosis is available;
- Relevant clinical information that was available to the sign-out pathologist in the pathology request form is available;
- Cases are at least one year since accessioning;
Who cannot join
- Cases, including sent out cases, for which the selected (representative) H\&E, IHC or special stains slide used for the original sign-out diagnosis is no longer available at the site.
- Cases for which the control slides for IHC and special stains are not available.
- The selected slide or slides for the main diagnosis and the control slide(s) do not fulfill the quality checks according to general clinical practice.
- Selected (representative) slides contain indelible markings.
- Selected (representative) slides with damaged tissue.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UCSF
San Francisco, California, 94143
Laszik, +1 415-476-3961, zoltan.laszik@ucsf.edu
- Recruiting
CCPL
Silver Spring, Maryland, 20904
Beltaifa, +1-240-637-5170, SBeltaif@adventisthealthcare.com
About this study
Official title: Clinical Study Protocol SGi 1.0 + EPW 1.0 + Compatible Clinical Displays Clinical Validation Study
The primary objective of this study is to show safety and effectiveness of the investigational device for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.
- Conditions
- Pathological Processes
- Being tested
- Digital pathology system
- Medical subject headings
- Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital pathology systemDiagnostic test
Surgical pathology slides are scanned with a digital pathology scanner after which they are viewed by a pathologist on a digital pathology viewer.
It is the task of the pathologist to define a diagnosis based on these images.
| Study group | Role | What they receive |
|---|---|---|
| Surgical pathology cases | Cases will be selected from the sites Laboratory Information Systems using the in- and exclusion criteria. Receives: Diagnostic Test: Digital pathology system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 the digital pathology system. 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.
Measured: 6 months
Secondary outcomes (3)
MD major discordance rate
- Explore the MD major discordance rate for individual organs, subtypes and pathologists
Measured: 6 months
MO major discordance rate
Explore the MO major discordance rate for individual organs, subtypes and pathologists;
Measured: 6 months
inter-pathologist major discordance rate
Explore the inter-pathologist major discordance rate.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological ProcessesStudies 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
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Digital & Computational Pathology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881874
- Sponsor's protocol ID
- DPS-CT-0025
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol SGi 1.0 + EPW 1.0 + Compatible Clinical Displays Clinical Validation Study
- ClinicalTrials.gov ID
- NCT07881874
- Acronym / sponsor ID
- DPS-CT-0025
- Conditions
- Pathological Processes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Philips Digital & Computational PathologyIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 20 Oct 2026 (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.
The primary objective of this study is to show safety and effectiveness of the investigational device for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical pathology cases | – | Diagnostic Test: Digital pathology systemCases will be selected from the sites Laboratory Information Systems using the in- and exclusion criteria. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Surgical Pathology cases are selected according pre-specified list consisting of consecutive cases from the archive with pre-specified organs and subtypes.
Key inclusion criteria (4 listed)
- All hematoxylin and eosin (H\&E), immunohistochemistry (IHC) and special stains glass coverslipped slide or slides, with human tissue obtained via surgical pathology of original case are available;
- Original sign-out diagnosis is available;
- Relevant clinical information that was available to the sign-out pathologist in the pathology request form is available;
- Cases are at least one year since accessioning;
Key exclusion criteria (5 listed)
- Cases, including sent out cases, for which the selected (representative) H\&E, IHC or special stains slide used for the original sign-out diagnosis is no longer available at the site.
- Cases for which the control slides for IHC and special stains are not available.
- The selected slide or slides for the main diagnosis and the control slide(s) do not fulfill the quality checks according to general clinical practice.
- Selected (representative) slides contain indelible markings.
- Selected (representative) slides with damaged tissue.
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 |
|---|---|---|
| Digital pathology systemSurgical pathology slides are scanned with a digital pathology scanner after which they are viewed by a pathologist on a digital pathology viewer. It is the task of the pathologist to define a diagnosis based on these images. | Diagnostic test | Surgical pathology cases |
Primary outcome
Major Discordance Rate
Time frame: 6 months
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 the digital pathology system. 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.
3 secondary outcomes
MD major discordance rate
Time frame: 6 months
MO major discordance rate
Time frame: 6 months
inter-pathologist major discordance rate
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathological Processes, run by Philips Digital & Computational Pathology at 2 sites 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Discordance Rate (time frame: 6 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 22 Oct 2026.