Clinical trial · Observational
Does the Aid of MelaFind Affect Clinical Management Decisions
To Excise or Not?: Comparing Clinical Management Decisions for Melanoma Between Dermatologists With and Without the Aid of MelaFind
- 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)
The objective of this study is to determine and compare the performance of dermatologists (in Germany) on the excision decision against the performance of MelaFind, a non-invasive and objective multi-spectral computer vision system designed as a tool to aid dermatologists in the detection of early melanoma. The hypothesis is that MelaFind's sensitivity is superior to the average excisions sensitivity of dermatologists. Another objective is to determine and compare the performance of dermatologists (in Germany) with and without the aid of MelaFind. The hypothesis is that the average excision sensitivity of dermatologists with the aid of MelaFind is superior to the average excision sensitivity of dermatologists without the aid of MelaFind. A similar study was previously conducted with dermatologists in the US (NCT01011153). An exploratory objective is to compare the excision decisions of dermatologists from the previous study (in the US) to dermatologists in in this study (in Germany).
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Without MelaFind
- description
- Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
- label
- With MelaFind
- description
- Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
- label
- Experts Without MelaFind
- description
- PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
Primary outcomes (2)
- measure
- Sensitivity
- timeFrame
- Within 120 days of Data Lock
- description
- Dermatologist sensitivity is the percent of melanomas that dermatologists selected to biopsy. MelaFind sensitivity is the percent of melanomas that MelaFind called "Positive."
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: -Only board certified dermatologists Exclusion Criteria: -May not have previously participated in MELA Protocols 20061, 20081 or 20063
References
Publications (0)
Data not yet available