The primary objective of this study to test the hypothesis that, among eligible and
evaluable lesions with central histological reference standard status melanoma or high-grade
lesion, the relative sensitivity ρ comparing enrolling dermatologists after MelaFind use
with enrolling dermatologists if MelaFind were not available is greater than 110%. This
represents a clinically meaningful increase in sensitivity.
The secondary objectives of this study are to evaluate real-world use and safety and
effectiveness of MelaFind in a clinical setting.
Observational Model: Cohort, Time Perspective: Prospective
Relative sensitivity of enrolling dermatologists after MelaFind use and enrolling dermatologists if MelaFind were not available.
United States: Institutional Review Board
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|The Johns Hopkins University||Baltimore, Maryland 21287|
|University Hospitals Case Medical Center||Cleveland, Ohio 44106|
|Dermatology Associates of Tallahassee||1707 Riggins Road, Tallahassee, Florida 32308|
|The Dermatology Group, P.C.||Verona, New Jersey 07044|