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Does the Aid of MelaFind Affect Clinical Management Decisions

NCT ID: NCT01387581

Last Updated: 2014-11-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Melanoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Without MelaFind

Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.

No interventions assigned to this group

With MelaFind

Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

-Only board certified dermatologists

Exclusion Criteria

-May not have previously participated in MELA Protocols 20061, 20081 or 20063
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MELA Sciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Axel Hauschild, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatologic Cooperative Oncology Group

Locations

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MELA Sciences

Irvington, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20101

Identifier Type: -

Identifier Source: org_study_id