Clinical Trial: MelaFind Evaluations for Patients With Multiple Nevi

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: MelaFind Evaluations for Patients With Multiple Nevi

Brief 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.

Detailed Summary:
Sponsor: MELA Sciences, Inc.

Current Primary Outcome: Multiple values and standard deviations of MelaFind scores for pigmented skin lesions [ Time Frame: 1 month ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: MELA Sciences, Inc.

Dates:
Date Received: October 2, 2012
Date Started: November 2012
Date Completion:
Last Updated: August 25, 2014
Last Verified: August 2014