MedPath

INTER-PATHOLOGIST READER STUDY

Conditions
Nevi, Dysplastic
Registration Number
NCT06246903
Lead Sponsor
Orlucent, Inc
Brief 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).

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
500
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Study Success8 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. \[5\]. \[(classes/agreement): class I (eg, nevus or mild atypia) / 92% (95% confidence interval 90% to 94); class II (eg, moderate atypia) / 25% (22% to 28%); III (eg, severe atypia or melanoma in situ) / 40% (37% to 44%); IV (eg, pathologic stage T1a (pT1a) early invasive melanoma) / 43% (39% to 46%); and V (eg, ≥pT1b invasive melanoma) / 72% (69% to 75%).\]

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Utah Hospital, Pathology

🇺🇸

Salt Lake City, Utah, United States

University of Utah Hospital, Pathology
🇺🇸Salt Lake City, Utah, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.