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Nevus Doctor Clinical Decision Support

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02012751
First Posted: December 16, 2013
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Tromso
The Research Council of Norway
Information provided by (Responsible Party):
University Hospital of North Norway
  Purpose
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
Nevus Melanoma Device: Nevus doctor program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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 ]
    Participating GPs are invited to interviews


Enrollment: 49
Study Start Date: October 2014
Study Completion Date: September 2016
Primary Completion Date: September 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pigmented skin lesion

Exclusion Criteria:

  Contacts and Locations
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): NCT02012751


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

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02012751     History of Changes
Other Study ID Numbers: 2013/1206
First Submitted: December 4, 2013
First Posted: December 16, 2013
Last Update Posted: October 28, 2016
Last Verified: June 2016

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

Additional relevant MeSH terms:
Melanoma
Nevus
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas