Does the Aid of MelaFind Affect Clinical Management Decisions

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

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).

Study Overview

• Status: Completed
• Conditions: Melanoma

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.

• Study Type: Observational
• Enrollment (Actual): 227

Contacts and Locations

Study Locations

• United States
  • New York
    • Irvington, New York, United States, 10533
      • MELA Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

-Only board certified dermatologists

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: MELA Sciences, Inc.
• Investigators: Principal Investigator: Axel Hauschild, MD, Dermatologic Cooperative Oncology Group

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 28, 2011
• First Submitted That Met QC Criteria: July 1, 2011
• First Posted (Estimate): July 4, 2011

Study Record Updates

• Last Update Posted (Estimate): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 5, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 20101