Nevus Doctor Clinical Decision Support

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University Hospital of North Norway
University of Tromso
The Research Council of Norway
Information provided by (Responsible Party):
University Hospital of North Norway Identifier:
First received: December 4, 2013
Last updated: December 16, 2015
Last verified: December 2015
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.

Condition Intervention
Device: Nevus doctor program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Nevus Doctor Clinical Decision Support Program for Pigmented Skin Lesions and Melanoma

Resource links provided by NLM:

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Number of correct test results [ Time Frame: Up to 2 weeks from enrollment ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Patterns regarding false test results [ Time Frame: Up to 2 weeks from enrollment ] [ Designated as safety issue: No ]
    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.

Other Outcome Measures:
  • User-friendliness [ Time Frame: 6-8 months after enrollment ] [ Designated as safety issue: No ]
    Participating GPs are invited to interviews

Estimated Enrollment: 100
Study Start Date: October 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pigmented skin lesion

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02012751

Contact: Thomas R Schopf, MD PhD 4791527503

Kirkenes Legesenter Recruiting
Kirkenes, Finnmark, Norway, 9915
Principal Investigator: Drude Bratlien, MD         
Sponsors and Collaborators
University Hospital of North Norway
University of Tromso
The Research Council of Norway
Principal Investigator: Thomas R Schopf, Ph.D. University Hospital North-Norway
  More Information

Responsible Party: University Hospital of North Norway Identifier: NCT02012751     History of Changes
Other Study ID Numbers: 2013/1206 
Study First Received: December 4, 2013
Last Updated: December 16, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health

Keywords provided by University Hospital of North Norway:
Computer-assisted diagnosis
General practice

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas processed this record on May 26, 2016