Pathologic ProcessesNCT02529137

Pivotal Study for Validation of Philips Dx (PDx)

An observational study of Pathologic Processes, run by Philips Digital & Computational Pathology at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to show safety and effectiveness of the PDx 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: Pathologic Processes
How many people: 2,000 participants
Where: 4 sitesUnited States
Study dates: Jul 2015to Sep 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: Both: surgical pathology slides of both female and male participants are being studied.

Who may be able to join

All relevant coverslipped slide or slides, with human tissue obtained via surgical pathology of original case are available.
Original sign-out diagnosis is available.
The selected slide or slides fulfill the quality checks according to general clinical practice.
Target enrollment of organs and subtypes according pre-specified list.

Who cannot join

Cases, including sent out cases, for which any of the relevant slides used for the original sign-out diagnosis is no longer available at the site.
The selected slide or slides do not match any subtype of the organ for which the case was selected.
Relevant Clinical Information that was available to the sign-out pathologist in the pathology request form cannot be obtained.
Selected slides contain indelible markings.
Selected slides with damaged tissue.
More than one case was selected for a patient (only one case may be enrolled per patient).
Case consists of frozen section(s) only.
Case consists of gross specimens only.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University of Virginia
Charlottesville, Virginia, 22908
Cleveland Clinic
Cleveland, Ohio, 44195
Miraca Life Sciences
Irving, Texas, 75039
Shady Grove Adventist
Silver Spring, Maryland, 20904

Other trials in United States

About this study

Official title: Pivotal Study for Validation of Philips Dx for Diagnosis in Surgical Pathology

Conditions: Pathologic Processes
Medical subject headings: Pathologic Processes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02529137
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.

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 PIPS. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Sep 2016

First posted20 Aug 2015 (estimated)
Study startJul 2015
Primary completionMay 2016
Study completionSep 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 Pathologic 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: 2,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02529137
Sponsor's protocol ID: DPS-CT-0007
Status last verified: May 2021
First submitted: 18 Aug 2015
Last updated: 28 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pivotal Study for Validation of Philips Dx for Diagnosis in Surgical Pathology
ClinicalTrials.gov ID: NCT02529137
Acronym / sponsor ID: DPS-CT-0007
Conditions: Pathologic Processes
Study type: Observational
Recruitment status: Completed
Enrolment: 2,000 participants (actual)
Lead sponsor: Philips Digital & Computational PathologyIndustry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: May 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 20 Aug 2015 (estimated)
Results: Posted 12 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Surgical pathology cases	–	–Cases will be selected from the sites Laboratory Information Systems using the in- and exclusion criteria.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Both: surgical pathology slides of both female and male participants are being studied.

Key inclusion criteria (4 listed)

All relevant coverslipped slide or slides, with human tissue obtained via surgical pathology of original case are available.
Original sign-out diagnosis is available.
The selected slide or slides fulfill the quality checks according to general clinical practice.
Target enrollment of organs and subtypes according pre-specified list.

Key exclusion criteria (8 listed)

Cases, including sent out cases, for which any of the relevant slides used for the original sign-out diagnosis is no longer available at the site.
The selected slide or slides do not match any subtype of the organ for which the case was selected.
Relevant Clinical Information that was available to the sign-out pathologist in the pathology request form cannot be obtained.
Selected slides contain indelible markings.
Selected 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.

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 PIPS. 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.

Results and safety

Results posted to the registry on 12 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Surgical Pathology Cases	2,000	1,992

Primary outcome: Major Discordance Rate

Time frame: 6 months. Number (95% Confidence Interval). Unit: percentage of major discordance

Measure	Manual Optical (MO) n = 1992	Manual Digital (MD) n = 1992
Value	4.4 (3.02 to 6.33)	4.7 (3.27 to 6.82)

Manual Optical (MO) vs Manual Digital (MD): difference: 0.4 (95% CI -0.30 to 1.01)

Population analysed: 8 cases were discontinued for reasons such as broken/damaged slide (1), slide size did not meet the scanner specifications (4), no tissue detected by the scanner (2) and more than one case was selected for the patient (1).

Adverse events

Time frame: From study start to study closure (11 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Surgical Pathology Cases	0 of 2,000 (0%)	0 of 2,000 (0%)	0 of 2,000

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
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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

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pathologic Processes, run by Philips Digital & Computational Pathology at 4 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 8 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 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Yes. Results are posted in the registry (first posted 12 Feb 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?

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?

On the ClinicalTrials.gov record for NCT02529137.

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 28 May 2021.