INTER-PATHOLOGIST READER STUDY

Nevi, Dysplastic Clinical Trial

Official title:

INTER-PATHOLOGIST READER STUDY

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06246903
• Other study ID #: SFI006
• Status: Enrolling by invitation
• Start date: June 15, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2024
• Source: Orlucent, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: August 1, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dysplastic Nevus Syndrome
• Nevi, Dysplastic

Locations

Country	Name	City	State
United States	University of Utah Hospital, Pathology	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Orlucent, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%).]	8 months