Clinical trial NCT01011153: Survey Study - Sensitivity Comparison Between MelaFind and Physician Group
Official title: Comparison of Diagnostic and Biopsy/Referral Sensitivity to Melanoma Between Three Groups of Physicians and MelaFind
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: MELA Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 241
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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).

Eligibility criteria: Inclusion Criteria:

* Board Certified physicians or equivalent

Exclusion Criteria:

* Did not participate in EOS Protocols 20061 or 20081

Primary outcomes:
measure: Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists)
timeFrame: April 2010
Secondary outcomes:
measure: 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
timeFrame: December 2009
measure: Determine the Interobserver Variability in Each of the Above Metrics Within Each of the Caregiver Groups.
timeFrame: December 2009
measure: 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.
timeFrame: June 2010
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: Suephy Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: