Melanoma
Conditions
Brief summary
The objective of this study is to determine and compare the performance of dermatologists (in Germany) on the excision decision against the performance of MelaFind, a non-invasive and objective multi-spectral computer vision system designed as a tool to aid dermatologists in the detection of early melanoma. The hypothesis is that MelaFind's sensitivity is superior to the average excisions sensitivity of dermatologists. Another objective is to determine and compare the performance of dermatologists (in Germany) with and without the aid of MelaFind. The hypothesis is that the average excision sensitivity of dermatologists with the aid of MelaFind is superior to the average excision sensitivity of dermatologists without the aid of MelaFind. A similar study was previously conducted with dermatologists in the US (NCT01011153). An exploratory objective is to compare the excision decisions of dermatologists from the previous study (in the US) to dermatologists in in this study (in Germany).
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. The diagnostic performance of dermatologists 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 excise the lesion. To aid dermatologists in the detection of early melanoma, MelaFind was developed, a non-invasive and objective multi-spectral computer vision system technology. It was designed to generate output - MelaFind Positive or MelaFind Negative- for consideration in the lesion management decisions. This survey study will determine and compare the average excision sensitivity to melanoma and specificity of dermatologists (in Germany) without MelaFind output to the average excision sensitivity to melanoma and specificity of dermatologists (in Germany) with MelaFind output. Another purpose is to determine and compare the sensitivity to melanoma and specificity of MelaFind to the average excision sensitivity to melanoma and specificity of dermatologists without MelaFind output.
Interventions
None listed
Sponsors
MELA Sciences, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
-Only board certified dermatologists
Exclusion criteria
-May not have previously participated in MELA Protocols 20061, 20081 or 20063
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | Within 120 days of Data Lock | Dermatologist sensitivity is the percent of melanomas that dermatologists selected to biopsy. MelaFind sensitivity is the percent of melanomas that MelaFind called Positive. |
| Specificity | Within 120 days of Data Lock | Dermatologist specificity is the percent of non-melanomas that dermatologists selected not to biopsy. MelaFind specificity is the percent of non-melanomas that MelaFind called Negative. |
Countries
United States
Participant flow
Recruitment details
Dermatologists were selected at random from Germany's public dermatology membership list and were invited to participate by letter. Those interested in participating were asked to register online. Eligible dermatologists were selected to participate on a first-come basis and were divided by random placement into one of two study arms.
Pre-assignment details
Dermatologists interested in participating were asked to register online by responding to an Intake Survey. The survey included questions about dermatology training, medical licensure, board certification, and comfort with and frequency of screening for melanoma. Only board certified dermatologists were permitted to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Without MelaFind Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result. | 101 |
| With MelaFind Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion | 101 |
| Experts Without MelaFind PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result. | 9 |
| Total | 211 |
Baseline characteristics
| Characteristic | Without MelaFind | With MelaFind | Experts Without MelaFind | Total |
|---|---|---|---|---|
| Age, Customized 31-40 years | 18 participants | 22 participants | 2 participants | 42 participants |
| Age, Customized 41-50 years | 48 participants | 44 participants | 5 participants | 97 participants |
| Age, Customized 51-60 years | 29 participants | 30 participants | 2 participants | 61 participants |
| Age, Customized > 60 years | 6 participants | 5 participants | 0 participants | 11 participants |
| Dermoscopy use Almost all | 28 participants | 31 participants | 1 participants | 60 participants |
| Dermoscopy use Always | 52 participants | 38 participants | 3 participants | 93 participants |
| Dermoscopy use < half of pigmented skin lesions | 4 participants | 16 participants | 3 participants | 23 participants |
| Dermoscopy use > half of pigmented skin lesions | 17 participants | 16 participants | 2 participants | 35 participants |
| Dermoscopy use Never | 0 participants | 0 participants | 0 participants | 0 participants |
| Dermoscopy use Rarely | 0 participants | 0 participants | 0 participants | 0 participants |
| Region of Enrollment Germany | 101 participants | 101 participants | 9 participants | 211 participants |
| Sex: Female, Male Female | 41 Participants | 43 Participants | 1 Participants | 85 Participants |
| Sex: Female, Male Male | 60 Participants | 58 Participants | 8 Participants | 126 Participants |
| Years in Practice 11 - 15 years | 26 participants | 23 participants | 2 participants | 51 participants |
| Years in Practice 16 - 20 years | 27 participants | 25 participants | 4 participants | 56 participants |
| Years in Practice 5 - 10 years | 8 participants | 17 participants | 1 participants | 26 participants |
| Years in Practice < 5 years | 1 participants | 0 participants | 0 participants | 1 participants |
| Years in Practice > 60 years | 39 participants | 36 participants | 2 participants | 77 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 108 | 0 / 107 | 0 / 12 |
| serious Total, serious adverse events | 0 / 108 | 0 / 107 | 0 / 12 |
Outcome results
Primary
Sensitivity
Dermatologist sensitivity is the percent of melanomas that dermatologists selected to biopsy. MelaFind sensitivity is the percent of melanomas that MelaFind called Positive.
Time frame: Within 120 days of Data Lock
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Without MelaFind | Sensitivity | 69.5 percent of true positives |
| With MelaFind | Sensitivity | 78.0 percent of true positives |
| Experts Without MelaFind | Sensitivity | 71.8 percent of true positives |
Primary
Specificity
Dermatologist specificity is the percent of non-melanomas that dermatologists selected not to biopsy. MelaFind specificity is the percent of non-melanomas that MelaFind called Negative.
Time frame: Within 120 days of Data Lock
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Without MelaFind | Specificity | 55.9 percent of true negatives |
| With MelaFind | Specificity | 45.8 percent of true negatives |
| Experts Without MelaFind | Specificity | 54.6 percent of true negatives |