MelaFind Evaluations for Patients With Multiple Nevi

• ClinicalTrials.gov Identifier: NCT01700101
• Recruitment Status: Completed
• First Posted: October 4, 2012
• Last Update Posted: August 26, 2014
• Sponsor: MELA Sciences, Inc.
• Information provided by (Responsible Party): MELA Sciences, Inc.

Study Description

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.

Condition or disease
Clinically Atypical Pigmented Skin Lesion

Study Design

• Study Type: Observational
• Actual Enrollment: 19 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: MelaFind Evaluations for Patients With Multiple Nevi
• Study Start Date: November 2012
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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

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:

Exclusion Criteria:

• 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)

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: MELA Sciences, Inc.
• ClinicalTrials.gov Identifier: NCT01700101
• Other Study ID Numbers: 20123
• First Posted: October 4, 2012
• Last Update Posted: August 26, 2014
• Last Verified: August 2014

Additional relevant MeSH terms:

Pigmentation Disorders; Skin Diseases; Pathologic Processes