An observational study in Nevi, Dysplastic, sponsored by Orlucent, Inc. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Orlucent, Inc · Observational
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).
22 studies on the registry are indexed under Dysplastic Nevus Syndrome; 6 are open to participants now.
This study's planned enrollment of 500 is above the median of 300 across 15 observational studies indexed under Dysplastic Nevus Syndrome.
Browse Dysplastic Nevus Syndrome studies →Orlucent, Inc is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Previous consented subject\'s scans from the Orlucent OMS002, SFI001 or SFI003 Studies and
Exclusion Criteria:
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
Plan to share: Undecided
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Orlucent, Inc