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).

Study Timeline

• Study Start: 2023-06-15
• Status Verified: 2024-01
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-06-20
• Study Completion: 2024-08-01

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

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

Trial Locations

Locations (1)

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