Survey Study - Sensitivity Comparison Between MelaFind and Physician Group

NCT ID: NCT01011153

Last Updated: 2012-02-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 241 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-02-28

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.

Detailed Description

Early detection of melanoma is critical for favorable prognosis, since patients with earlier stage melanomas have a much higher probability of survival than with later stages. The traditional method of early detection has been with serial total body skin exams where the health care provider examines all skin surfaces, including mucosa, for suspicious pigmented lesions. Studies have demonstrated that the diagnostic accuracy of physicians for melanoma depends on the level of dermatological training. More important than being able to make a diagnosis of melanoma on clinical impression is the ability to make an appropriate decision to biopsy the lesion. Primary care physicians (PCPs) are often expected to screen for melanoma and only refer to dermatologists when there is a high clinical suspicion of melanoma. However, if PCPs are not adept at diagnosing melanoma, then opportunities for early diagnosis and treatment could be missed. Conversely, the morphology of benign pigmented lesions can often mimic that of early melanomas, resulting in potentially unnecessary dermatology referrals, biopsies, and patient anxiety. Studies have indicated that there is great variability in the ability of PCPs to make a correct decision to biopsy/refer a pigmented lesion (1.5 times greater than dermatologists) as well as for diagnosing melanoma (over 2.5 times greater than dermatologists). To aid in detection of early melanomas, new technologies are being developed.

One such technology is MelaFind, an investigational device that has been developed to give a recommendation for biopsy (or not) of pigmented skin lesions to rule out melanoma. Our hypothesis is that MelaFind will have equal or better sensitivity than pigmented lesion experts in making an appropriate recommendation for biopsy (i.e., MelaFind will be at least as accurate as dermatologists in recommending biopsy for melanomas).

Conditions

Melanoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

All Dermatologists

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Board Certified physicians or equivalent

Exclusion Criteria

• Did not participate in EOS Protocols 20061 or 20081

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MELA Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suephy Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Other Identifiers

20063

Identifier Type: -

Identifier Source: org_study_id