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Trial Title:
INTER-PATHOLOGIST READER STUDY
NCT ID:
NCT06246903
Condition:
Nevi, Dysplastic
Conditions: Official terms:
Dysplastic Nevus Syndrome
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Retrospective
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).
Criteria for eligibility:
Study pop:
Previous consented subject's scans from the Orlucent OMS002, SFI001 or SFI003 Studies
and
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Utah Hospital, Pathology
Address:
City:
Salt Lake City
Zip:
84132
Country:
United States
Start date:
June 15, 2023
Completion date:
August 1, 2024
Lead sponsor:
Agency:
Orlucent, Inc
Agency class:
Industry
Source:
Orlucent, Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06246903