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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suspicious nevus/nevi |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Previous consented subject's scans from the Orlucent OMS002, SFI001 or SFI003 Studies and
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| Name | Affiliation | Role |
|---|---|---|
| Cathy Shachaf, PhD | Founder and President | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Hospital, Pathology | Salt Lake City | Utah | 84132 | United States |
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| ID | Term |
|---|---|
| D004416 | Dysplastic Nevus Syndrome |
| ID | Term |
|---|---|
| D009506 | Nevus |
| D018326 | Nevi and Melanomas |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D009386 |
| Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |