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
Observational Model: Cohort, Time Perspective: Prospective
Relative sensitivity of enrolling dermatologists after MelaFind use and enrolling dermatologists if MelaFind were not available.
5 years
No
United States: Institutional Review Board
Protocol 20111
NCT01700114
November 2012
Name | Location |
---|---|
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 |