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Comparison of Diagnostic and Biopsy/Referral Sensitivity to Melanoma Between Three Groups of Physicians and MelaFind

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Trial Information

Comparison of Diagnostic and Biopsy/Referral Sensitivity to Melanoma Between Three Groups of Physicians and MelaFind

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).

Inclusion Criteria:

- Board Certified physicians or equivalent

Exclusion Criteria:

- Did not participate in EOS Protocols 20061 or 20081

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists)

Outcome Description:

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.

Outcome Time Frame:

April 2010

Safety Issue:


Principal Investigator

Suephy Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University


United States: Institutional Review Board

Study ID:




Start Date:

October 2009

Completion Date:

February 2010

Related Keywords:

  • Melanoma
  • Melanoma