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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without MelaFind | Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result. | ||
| With MelaFind | Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Dermatologist sensitivity is the percent of melanomas that dermatologists selected to biopsy. MelaFind sensitivity is the percent of melanomas that MelaFind called "Positive." | Within 120 days of Data Lock |
| 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." | Within 120 days of Data Lock |
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Inclusion Criteria:
-Only board certified dermatologists
Exclusion Criteria:
-May not have previously participated in MELA Protocols 20061, 20081 or 20063
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130 dermatologists will enter by way of general invitation and will be randomly placed in either Arm 1 (Without MelaFind) or Arm 2 (With MelaFind). Another group, up to 30 Pigmented Skin Lesion Experts, will be prospectively identified by the Principal Investigator of this study prior to any participant recruitment, and will be invited to participate in the study by the PI after the general recruitment is completed.
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| Name | Affiliation | Role |
|---|---|---|
| Axel Hauschild, MD | Dermatologic Cooperative Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MELA Sciences | Irvington | New York | 10533 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Without MelaFind | Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result. |
| FG001 | With MelaFind | Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Without MelaFind | Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result. |
| BG001 | With MelaFind | Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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." | Posted | Mean | 95% Confidence Interval | percent of true positives | Within 120 days of Data Lock |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Without MelaFind | Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result. |
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A limitation of this study is the reader study format. Lesions were presented to participating dermatologists as photographs via the online system. This presentation can only approximate an in-person clinical exam.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrinalini Roy | MelaSciences | 800-729-8849 | mishti@melasciences.com |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dermoscopy use | Number | participants |
|
| Years in Practice | Number | participants |
|
| OG002 |
| 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. |
|
|
| 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." | Posted | Mean | 95% Confidence Interval | percent of true negatives | Within 120 days of Data Lock |
|
|
|
| 0 |
| 108 |
| 0 |
| 108 |
| EG001 | With MelaFind | Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion | 0 | 107 | 0 | 107 |
| EG002 | 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. | 0 | 12 | 0 | 12 |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |