Does the Aid of MelaFind Affect Clinical Management Decisions

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).

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

MELA Sciences

Irvington, New York, 10533, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Only board certified dermatologists

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Sensitivity

Time frame: 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

Time frame: 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."

Sponsors and collaborators

Lead sponsor

MELA Sciences, Inc.

Industry

Registry information

Official study title

To Excise or Not?: Comparing Clinical Management Decisions for Melanoma Between Dermatologists With and Without the Aid of MelaFind

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jul 4, 2011
Registry last updated: Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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