Survey Study - Sensitivity Comparison Between MelaFind and Physician Group

NCT01011153 | Completed Results

• 1 other identifier: 20063
• Study Type: observational
• Target: 241
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

All Dermatologists

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Board Certified physicians or equivalent

You may not qualify if:

• Did not participate in EOS Protocols 20061 or 20081

Sponsors & Collaborators

• MELA Sciences, Inc.: lead

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

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

• Title: Joanna Adrian, Director of Clinical Operatons and Medical Affairs
• Organization: MELA Sciences, Inc.

adrian@melasciences.com

914-591-3783

Study Officials

• Suephy Chen, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 14, 2012
• Results First Posted: January 24, 2011

Record last verified: 2012-02