NCT01700101|Completed
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Sponsor study identifier
observational
19
0 countries
N/A
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2, 2012
Actual (reported)October 4, 2012
Actual (reported)November 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 2014
Actual (reported)June 2014
Actual (reported)Multiple values and standard deviations of MelaFind scores for pigmented skin lesions
1 month
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
19 participants (actual enrollment reported by the registry).
First Submitted
October 2, 2012
First Posted
October 4, 2012
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
August 26, 2014
Record last verified: 2014-08
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Source: ClinicalTrials.gov.
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