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Survey Study - Sensitivity Comparison Between MelaFind and Physician Group

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MELA Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01011153
First received: November 10, 2009
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
Results First Received: May 26, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: Melanoma

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Physicians were selected from the membership list of the AAD and lists provided by SK&A Healthcare Information Solutions. A letter was then sent inviting them to participate. For each who replied positively,an access code was mailed with which to log on to the study. 241 subjects logged into system,183 signed consents & completed the Intake Survey.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were grouped according to responses to an Intake Survey, completed after Consent and before reading any study cases. A maximum of 130 cases were reviewed,each one consisting of 3 clinical images and a case history. MelaFind results were not provided as part of each case and were only used for sensitivity and specificity calculations.

Reporting Groups
  Description
General Dermatologists Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
Pigmented Skin Lesion Experts Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
Primary Care Physicians Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).

Participant Flow:   Overall Study
    General Dermatologists     Pigmented Skin Lesion Experts     Primary Care Physicians  
STARTED     54     75     54  
COMPLETED     46     64     45  
NOT COMPLETED     8     11     9  
Less than 78 cases completed                 8                 11                 9  



  Baseline Characteristics
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Reporting Groups
  Description
General Dermatologists Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
Pigmented Skin Lesion Experts Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
Primary Care Physicians Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
Total Total of all reporting groups

Baseline Measures
    General Dermatologists     Pigmented Skin Lesion Experts     Primary Care Physicians     Total  
Number of Participants  
[units: participants]
 		  54     75     54     183  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     54     75     54     183  
>=65 years     0     0     0     0  
Gender, Customized  
[units: participants]
 		       
Female     16     36     23     75  
Male     32     35     26     93  
Unknown     6     4     5     15  
Region of Enrollment  
[units: participants]
 		       
United States     54     75     54     183  



  Outcome Measures
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1.  Primary:   Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists)   [ Time Frame: April 2010 ]
  Show Outcome Measure 1

2.  Secondary:   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   [ Time Frame: December 2009 ]
  Show Outcome Measure 2

3.  Secondary:   Determine the Interobserver Variability in Each of the Above Metrics Within Each of the Caregiver Groups.   [ Time Frame: December 2009 ]
  Show Outcome Measure 3

4.  Secondary:   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.   [ Time Frame: June 2010 ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The only limitation to having complete data sets was the time a physician was willing to spend on completing the survey.  


Results Point of Contact:  
Name/Title: Joanna Adrian, Director of Clinical Operatons and Medical Affairs
Organization: MELA Sciences, Inc.
phone: 914-591-3783 ext 732
e-mail: adrian@melasciences.com


No publications provided


Responsible Party: MELA Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01011153     History of Changes
Other Study ID Numbers: 20063
Study First Received: November 10, 2009
Results First Received: May 26, 2010
Last Updated: February 10, 2012
Health Authority: United States: Institutional Review Board