Does the Aid of MelaFind Affect Clinical Management Decisions
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Purpose
The objective of this study is to determine and compare the performance of dermatologists 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 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.
| Condition |
|---|
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Melanoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | To Excise or Not?: Comparing Clinical Management Decisions for Melanoma Between Dermatologists With and Without the Aid of MelaFind |
| Enrollment: | 228 |
| Study Start Date: | October 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Arm 1
Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
|
|
Arm 2
Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
|
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Arm 3
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.
|
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 without MelaFind output to the average excision sensitivity to melanoma and specificity of dermatologists 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
130 dermatologists will enter by way of general invitation and will be randomly placed in either Arm 1 or Arm 2. 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.
Inclusion Criteria:
-Only board certified dermatologists
Exclusion Criteria:
-May not have previously participated in MELA Protocols 20061, 20081 or 20063
Contacts and Locations| United States, New York | |
| MELA Sciences | |
| Irvington, New York, United States, 10533 | |
| Principal Investigator: | Axel Hauschild, MD | Dermatologic Cooperative Oncology Group |
More Information
No publications provided
| Responsible Party: | MELA Sciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT01387581 History of Changes |
| Other Study ID Numbers: | 20101 |
| Study First Received: | June 28, 2011 |
| Last Updated: | April 24, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on June 17, 2013