NCT01387581|CompletedResults
Does the Aid of MelaFind Affect Clinical Management Decisions
To Excise or Not?: Comparing Clinical Management Decisions for Melanoma Between Dermatologists With and Without the Aid of MelaFind
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To Excise or Not?: Comparing Clinical Management Decisions for Melanoma Between Dermatologists With and Without the Aid of MelaFind
Sponsor study identifier
observational
227
1 country
1
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)The objective of this study is to determine and compare the performance of dermatologists (in Germany) on the excision decision against the performance of MelaFind, a non-invasive and objective multi-spectral computer vision system designed as a tool to aid dermatologists in the detection of early melanoma. The hypothesis is that MelaFind's sensitivity is superior to the average excisions sensitivity of dermatologists. Another objective is to determine and compare the performance of dermatologists (in Germany) with and without the aid of MelaFind. The hypothesis is that the average excision sensitivity of dermatologists with the aid of MelaFind is superior to the average excision sensitivity of dermatologists without the aid of MelaFind. A similar study was previously conducted with dermatologists in the US (NCT01011153). An exploratory objective is to compare the excision decisions of dermatologists from the previous study (in the US) to dermatologists in in this study (in Germany).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2012
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.
June 28, 2011
Actual (reported)July 4, 2011
Actual (reported)October 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 2012
Actual (reported)March 2012
Actual (reported)November 14, 2014
Actual (reported)Sensitivity
Dermatologist sensitivity is the percent of melanomas that dermatologists selected to biopsy. MelaFind sensitivity is the percent of melanomas that MelaFind called "Positive."
Within 120 days of Data Lock
Specificity
Dermatologist specificity is the percent of non-melanomas that dermatologists selected not to biopsy. MelaFind specificity is the percent of non-melanomas that MelaFind called "Negative."
Within 120 days of Data Lock
Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
130 dermatologists will enter by way of general invitation and will be randomly placed in either Arm 1 (Without MelaFind) or Arm 2 (With MelaFind). Another group, up to 30 Pigmented Skin Lesion Experts, will be prospectively identified by the Principal Investigator of this study prior to any participant recruitment, and will be invited to participate in the study by the PI after the general recruitment is completed.
MELA Sciences
Irvington, New York, 10533, United States
A limitation of this study is the reader study format. Lesions were presented to participating dermatologists as photographs via the online system. This presentation can only approximate an in-person clinical exam.
Axel Hauschild, MD
Dermatologic Cooperative Oncology Group
227 participants (actual enrollment reported by the registry).
First Submitted
June 28, 2011
First Posted
July 4, 2011
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Use of Fiber-optic Probe for Non-invasive Diagnosis of Melanoma and Assessment of Impact of Ultraviolet (UV) Exposure on Skin
Contact the study team to confirm eligibility.
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)Last Updated
November 14, 2014
Results First Posted
November 14, 2014
Record last verified: 2014-11
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Source: ClinicalTrials.gov.
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