Does the Aid of MelaFind Affect Clinical Management Decisions

NCT01387581 | Completed Results

• 1 other identifier: 20101
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Only board certified dermatologists

You may not qualify if:

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

Sponsors & Collaborators

• MELA Sciences, Inc.: lead

Study Sites (1)

MELA Sciences

Irvington, New York, 10533, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

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.

Results Point of Contact

• Title: Mrinalini Roy
• Organization: MelaSciences

mishti@melasciences.com

800-729-8849

Study Officials

• Axel Hauschild, MD

  Dermatologic Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: July 4, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 14, 2014
• Results First Posted: November 14, 2014

Record last verified: 2014-11

Locations

US (1)