Clinically Atypical Pigmented Skin Lesion Clinical Trial
Official title:
MelaFind Evaluations for Patients With Multiple Nevi
We have added objectives 4-6 to our updated study:
Study Objective 1: To determine whether the distribution of MelaFind scores is different for
different patients with multiple nevi, and whether such distributions can be utilized to
identify "signature" lesions for a given patient.
Study Objective 2: To investigate whether distributions of quantitative ABCD parameters
differ among patients and whether these qABCD parameters identify "signature" lesions.
Study Objective 3: To determine the feasibility of defining and using relative thresholds to
improve the specificity of MelaFind without sacrificing its high sensitivity.
Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for
different patient and lesion characteristics.
Study Objective 5: To identify patient and lesion characteristics that result in the highest
variability of MelaFind scores for a given lesion.
Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual
threshold for lesions to be considered for biopsy to rule out melanoma on patients with
multiple nevi.
n/a
Observational Model: Cohort, Time Perspective: Prospective