MelaFind Evaluations for Patients With Multiple Nevi

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MELA Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01700101
First received: October 2, 2012
Last updated: August 25, 2014
Last verified: August 2014

October 2, 2012
August 25, 2014
November 2012
June 2014   (final data collection date for primary outcome measure)
Multiple values and standard deviations of MelaFind scores for pigmented skin lesions [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01700101 on ClinicalTrials.gov Archive Site
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MelaFind Evaluations for Patients With Multiple Nevi
MelaFind Evaluations for Patients With Multiple Nevi

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Clinically Atypical Pigmented Skin Lesion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
June 2014
June 2014   (final data collection date for primary outcome measure)

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)
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01700101
20123
No
MELA Sciences, Inc.
MELA Sciences, Inc.
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MELA Sciences, Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP