Clinical trial NCT01700101: MelaFind Evaluations for Patients With Multiple Nevi
Official title: MelaFind Evaluations for Patients With Multiple Nevi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinically Atypical Pigmented Skin Lesion
Lead sponsor: MELA Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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)

Primary outcomes:
measure: Multiple values and standard deviations of MelaFind scores for pigmented skin lesions
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: