MelaFind Evaluations for Patients With Multiple Nevi

NCT01700101 | Completed

• 1 other identifier: 20123
• Study Type: observational
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clinically Atypical Pigmented Skin Lesion

Outcome Measures

Primary Outcomes (1)

• Multiple values and standard deviations of MelaFind scores for pigmented skin lesions

  1 month

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have at least one lesion that meets the inclusion/exclusion criteria (see eligibility criteria below) AND each lesion enrolled must be clinically atypical (i.e., contain at least one of the following ABCDEPRU characteristics: Asymmetry, Border irregularity, Color variegation, Diameter \< 6 mm, Evolving, Patient's concern, Regression, Ugly duckling). Lesions should be selected to have characteristics that may affect the repeatability of lesion scores: anatomic site (often exposed to UV - sun or tanning beds - or not; sun-damage may affect the repeatability); lesion diameter (6 mm, e.g. \~5 mm or \> 6 mm, e.g., 10 mm); and melanin content relative to normal skin (dark pigmentation or light pigmentation). A maximum of 8 lesions may be enrolled per patient

You may qualify if:

• 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;

You may not qualify if:

• The patient has a known allergy to isopropyl alcohol
• The lesion has been previously biopsied, excised, or traumatized
• The skin is not intact (e.g., open sores, ulcers, bleeding)
• The lesion is within 1 cm of the eye
• The lesion is on mucosal surfaces (e.g., lips, genitals)
• The lesion is on palmar hands
• The lesion is on plantar feet
• The lesion is on or under nails
• The lesion is located on or in an area of visible scarring
• The lesion contains foreign matter (e.g., tattoo, splinter, marker)

Sponsors & Collaborators

• MELA Sciences, Inc.: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 4, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 26, 2014

Record last verified: 2014-08