INTER-PATHOLOGIST READER STUDY

Orlucent, Inc500 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Nevi, Dysplastic

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

University of Utah Hospital, Pathology

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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. \[5\]. \[(classes/agreement): class I (eg, nevus or mild atypia) / 92% (95% confidence interval 90% to 94); class II (eg, moderate atypia) / 25% (22% to 28%); III (eg, severe atypia or melanoma in situ) / 40% (37% to 44%); IV (eg, pathologic stage T1a (pT1a) early invasive melanoma) / 43% (39% to 46%); and V (eg, ≥pT1b invasive melanoma) / 72% (69% to 75%).\]

Time frame: 8 months

Data from ClinicalTrials.gov

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