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Does the Aid of MelaFind Affect Clinical Management Decisions

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ClinicalTrials.gov Identifier: NCT01387581
Recruitment Status : Completed
First Posted : July 4, 2011
Results First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
MELA Sciences, Inc.

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).


Condition or disease
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
Actual Enrollment : 227 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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."

  2. 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."



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

-Only board certified dermatologists

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387581


Locations
United States, New York
MELA Sciences
Irvington, New York, United States, 10533
Sponsors and Collaborators
MELA Sciences, Inc.
Investigators
Principal Investigator: Axel Hauschild, MD Dermatologic Cooperative Oncology Group

Responsible Party: MELA Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01387581     History of Changes
Other Study ID Numbers: 20101
First Posted: July 4, 2011    Key Record Dates
Results First Posted: November 14, 2014
Last Update Posted: November 14, 2014
Last Verified: November 2014

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