NCT01011153|CompletedResults
Survey Study - Sensitivity Comparison Between MelaFind and Physician Group
Comparison of Diagnostic and Biopsy/Referral Sensitivity to Melanoma Between Three Groups of Physicians and MelaFind
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Comparison of Diagnostic and Biopsy/Referral Sensitivity to Melanoma Between Three Groups of Physicians and MelaFind
Sponsor study identifier
observational
241
0 countries
N/A
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2010
Actual (reported)Study Completion
February 2010
Actual (reported)This survey study purposes to determine and compare the biopsy/referral sensitivity and specificity of MelaFind to the average biopsy/referral sensitivity and specificity of dermatologists. 241 subjects logged into system but only 183 signed consents and completed the intake survey. Out of these 183, 155 were accounted for in the data analysis after exclusions were removed from the pool of subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2010
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 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 10, 2009
Actual (reported)November 11, 2009
Actual (reported)February 2010
Actual (reported)February 2010
Actual (reported)January 24, 2011
Actual (reported)Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists)
Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of all dermatologists to that of MelaFind. These metrics, for both the dermatologists and MelaFind, were calculated based on the same 130 lesions.
April 2010
Comparison of Biopsy/Referral Sensitivity and Specificity of MelaFind to the Average of Biopsy/Referral Sensitivity & Specificity in Each of the Three Groups of Physicians: Pigmented Skin Lesion Experts, General Dermatologists, and Primary Care Physicians
December 2009
Determine the Interobserver Variability in Each of the Above Metrics Within Each of the Caregiver Groups.
December 2009
To Compare Biopsy/Referral Performance and Diagnostic Performance Using Areas Under the Corresponding Receiver Operating Characteristic (ROC) Curves That Illustrate the Trade-offs Between Sensitivity and Specificity Between Three Groups of Physicians.
June 2010
Three groups of health care providers who commonly encounter the skin will participate in the study. The population will comprise ninety physicians of which thirty are pigmented skin lesions experts, thirty general dermatologists and thirty primary care physicians.
The only limitation to having complete data sets was the time a physician was willing to spend on completing the survey.
Suephy Chen, MD
Emory University
241 participants (actual enrollment reported by the registry).
First Submitted
November 10, 2009
First Posted
November 11, 2009
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016)
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Primary Completion
February 2010
Actual (reported)Study Completion
February 2010
Actual (reported)Last Updated
February 14, 2012
Results First Posted
January 24, 2011
Record last verified: 2012-02
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Source: ClinicalTrials.gov.
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