MelaFind Evaluations for Patients With Multiple Nevi

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
MELA Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01700101
First received: October 2, 2012
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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
Clinically Atypical Pigmented Skin Lesion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MelaFind Evaluations for Patients With Multiple Nevi

Resource links provided by NLM:


Further study details as provided by MELA Sciences, Inc.:

Primary Outcome Measures:
  • Multiple values and standard deviations of MelaFind scores for pigmented skin lesions [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: MELA Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01700101     History of Changes
Other Study ID Numbers: 20123
Study First Received: October 2, 2012
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on April 22, 2014