Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
19 participants
OBSERVATIONAL
2012-11-30
2014-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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;
Exclusion Criteria
* 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)
ALL
Yes
Sponsors
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MELA Sciences, Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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20123
Identifier Type: -
Identifier Source: org_study_id
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