Nevus Doctor Clinical Decision Support

Nevus Doctor Clinical Decision Support Program for Pigmented Skin Lesions and Melanoma

The "Nevus doctor" is a dermatoscopy based computer decision support tool to assist general practitioners (GPs) in the classification of pigmented skin lesions (PSLs). The aim of the program "Nevus doctor" is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious PSLs that need biopsy or referral to specialist health care for further assessment. The aim of this study is to investigate the diagnostic performance of the decision support tool in a primary care setting in Norway. We hypothesize that the diagnostic accuracy of the computer program "Nevus doctor" is better than the performance of the GPs.

Study Overview

• Status: Completed
• Conditions: Melanoma; Nevus
• Intervention / Treatment: Device: Nevus doctor program

Detailed Description

In the trial GPs examine patients who attend a primary health care center. A given PSL is first assessed clinically by the GP and afterwards photographed. A clinical photograph as well as a dermatoscopic photograph is taken, the latter using a dermatoscope attached to the lens of the camera. The dermatoscopic image is then processed by the computer program. The performance of "Nevus doctor" is compared with the GPs' assessment. A dermatologist reviews all cases based on the clinical and dermatoscopic photographs and this assessment serves as the reference standard.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Finnmark
    • Kirkenes, Finnmark, Norway, 9915
      • Kirkenes Legesenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pigmented skin lesion

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nevus doctor program; Use of Nevus doctor program to assess the diagnostic category of pigmented skin lesions	Device: Nevus doctor program; The Nevus doctor program supplies a diagnostic category of pigmented skin lesions based on dermatoscopy images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of correct test results	The computer program tests whether the appearance of a skin lesion is suggestive of skin cancer. There are two possible test outcomes: "suspicious" or "not suspicious". The reference standard is the assessment done by a dermatologist. The number (and percentage) of skin lesions correctly classified as "suspicious" or "not suspicious" is reported. Furthermore sensitivity, specificity, positive and negative predictive values are calculated.	Up to 2 weeks from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patterns regarding false test results	All cases with false test results are described in order to identify any pattern that can help to explain the false test result: correlation with specific types of skin lesions, poor image quality, gender and age of the patients.	Up to 2 weeks from enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
User-friendliness	Participating GPs are invited to interviews	6-8 months after enrollment

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: University of Tromso; The Research Council of Norway
• Investigators: Principal Investigator: Thomas R Schopf, Ph.D., University Hospital North-Norway

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): October 28, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Melanoma; General practice; Nevus; Computer-assisted diagnosis; Dermatoscopy
• 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; Nevus
• Other Study ID Numbers: 2013/1206