INTER-PATHOLOGIST READER STUDY

Orlucent

Status: Invitation-only

Conditions: Nevi, Dysplastic

Study type: Observational

Funder types: Industry

Identifiers

NCT06246903

SFI006

Details and patient eligibility

About

This is a post study histology analysis from previously obtained pathology slides.

Full 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).

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

suspicious nevus/nevi