Clinical trial · Observational
INTER-PATHOLOGIST READER STUDY
NCT06246903CI-TRIAL-00073794unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a post study histology analysis from previously obtained pathology slides.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nevi, Dysplastic | Cutaneous Dysplastic Nevus | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- suspicious nevus/nevi
Primary outcomes (1)
- measure
- Study Success
- timeFrame
- 8 months
- description
- 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. \[5\]. \[(classes/agreement): class I (eg, nevus or mild atypia) / 92% (95% confidence interval 90% to 94); class II (eg, moderate atypia) / 25% (22% to 28%); III (eg, severe atypia or melanoma in situ) / 40% (37% to 44%); IV (eg, pathologic stage T1a (pT1a) early invasive melanoma) / 43% (39% to 46%); and V (eg, ≥pT1b invasive melanoma) / 72% (69% to 75%).\]
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.