MelaFind Evaluations for Patients With Multiple Nevi
NCT01700101 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19
Last updated 2014-08-26
Summary
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.
Conditions
- Clinically Atypical Pigmented Skin Lesion
Sponsors & Collaborators
-
MELA Sciences, Inc.
lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2014-06-30
- Completion
- 2014-06-30
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