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Trial Title: INTER-PATHOLOGIST READER STUDY

NCT ID: NCT06246903

Condition: Nevi, Dysplastic

Conditions: Official terms:
Dysplastic Nevus Syndrome

Study type: Observational

Overall status: Enrolling by invitation

Study design:

Time perspective: Retrospective

Summary: 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).

Criteria for eligibility:

Study pop:
Previous consented subject's scans from the Orlucent OMS002, SFI001 or SFI003 Studies and

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: 1. Histology scans must have been obtained from previous consented subjects that allows post study ad hoc analyses. 2. Histology scans must be available from the data collected from the Orlucent OMS002, SFI001 or SFI003 Studies and are of good quality. Exclusion Criteria: - NA

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Utah Hospital, Pathology

Address:
City: Salt Lake City
Zip: 84132
Country: United States

Start date: June 15, 2023

Completion date: August 1, 2024

Lead sponsor:
Agency: Orlucent, Inc
Agency class: Industry

Source: Orlucent, Inc

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06246903

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