MelaFind Evaluations for Patients With Multiple Nevi

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01700101

Enrollment

Registered

2012-10-04

Start date

2012-11-30

Completion date

2014-06-30

Last updated

2014-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinically Atypical Pigmented Skin Lesion

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

Cutaneous lesions examined with MelaFind must satisfy all of the following inclusion criteria: Inclusion Criteria: * The lesion is pigmented (i.e., melanin, keratin, blood) * The diameter of the pigmented area is not \< 2 mm, and not \> 22 mm * The lesion is accessible to the MelaFind * The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form; Cutaneous lesions that meet any of the following

Exclusion criteria

will not be accepted:

Design outcomes

Primary

Measure	Time frame
Multiple values and standard deviations of MelaFind scores for pigmented skin lesions	1 month

Outcome results