MelaFind Evaluations for Patients With Multiple Nevi

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MELA Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01700101
First received: October 2, 2012
Last updated: June 20, 2014
Last verified: June 2014
  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: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014