Nevi, DysplasticNCT06246903
INTER-PATHOLOGIST READER STUDY
An observational study of Nevi, Dysplastic, run by Orlucent, Inc at 1 site in United States.
Trial summary
This is a post study histology analysis from previously obtained pathology slides. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nevi, Dysplastic
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 1 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Previous consented subject\'s scans from the Orlucent OMS002, SFI001 or SFI003 Studies and
Who may be able to join
- Histology scans must have been obtained from previous consented subjects that allows post study ad hoc analyses.
- Histology scans must be available from the data collected from the Orlucent OMS002, SFI001 or SFI003 Studies and are of good quality.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Hospital, Pathology
Salt Lake City, Utah, 84132
About this study
This is a post study histology analysis from previously obtained pathology slides.
Read the detailed description
This is a post study histology analysis. Pathologists will use digital histology slide scans of suspicious nevus/nevi obtained from previously conducted studies to provide histopathology gradations of histological features as outlined in the Orlucent histology atlas (LBL0713 Histopathology Atlas for Grading of Dysplastic Nevi and DEF0713-1 Histopathology Definitions for LBL0713).
- Conditions
- Nevi, Dysplastic
- Medical subject headings
- Dysplastic Nevus Syndrome
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 |
|---|---|---|
| suspicious nevus/nevi | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Success
This is a data collection study. Study success is considered when the interpathology agreement is improved when compared to the agreement identified in Elmore et al. [5]. [(classes/agreement): class I (eg, nevus or mild atypia) / 92% (95% confidence interval 90% to 94); class II (eg, moderate atypia) / 25% (22% to 28%); III (eg, severe atypia or melanoma in situ) / 40% (37% to 44%); IV (eg, pathologic stage T1a (pT1a) early invasive melanoma) / 43% (39% to 46%); and V (eg, ≥pT1b invasive melanoma) / 72% (69% to 75%).]
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start15 Jun 2023
- Primary completion20 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nevi, DysplasticStudies 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orlucent, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cathy Shachaf, PhD, Study director, Founder and President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246903
- Sponsor's protocol ID
- SFI006
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTER-PATHOLOGIST READER STUDY
- ClinicalTrials.gov ID
- NCT06246903
- Acronym / sponsor ID
- SFI006
- Conditions
- Nevi, Dysplastic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Orlucent, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 7 Feb 2024 (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 is a post study histology analysis from previously obtained pathology slides.
Detailed description
This is a post study histology analysis. Pathologists will use digital histology slide scans of suspicious nevus/nevi obtained from previously conducted studies to provide histopathology gradations of histological features as outlined in the Orlucent histology atlas (LBL0713 Histopathology Atlas for Grading of Dysplastic Nevi and DEF0713-1 Histopathology Definitions for LBL0713).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suspicious nevus/nevi | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Previous consented subject\'s scans from the Orlucent OMS002, SFI001 or SFI003 Studies and
Key inclusion criteria (2 listed)
- Histology scans must have been obtained from previous consented subjects that allows post study ad hoc analyses.
- Histology scans must be available from the data collected from the Orlucent OMS002, SFI001 or SFI003 Studies and are of good quality.
Key exclusion criteria (1 listed)
- NA
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
Study Success
Time frame: 8 months
This is a data collection study. Study success is considered when the interpathology agreement is improved when compared to the agreement identified in Elmore et al. [5]. [(classes/agreement): class I (eg, nevus or mild atypia) / 92% (95% confidence interval 90% to 94); class II (eg, moderate atypia) / 25% (22% to 28%); III (eg, severe atypia or melanoma in situ) / 40% (37% to 44%); IV (eg, pathologic stage T1a (pT1a) early invasive melanoma) / 43% (39% to 46%); and V (eg, ≥pT1b invasive melanoma) / 72% (69% to 75%).]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Cathy Shachaf, PhD study director
Founder and President
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 Nevi, Dysplastic, run by Orlucent, Inc 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 2 inclusion and 1 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 7 Feb 2024. 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?
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?
Study Success (time frame: 8 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 7 Feb 2024.