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Completed

NCT Number: NCT02012751

Nevus Doctor Clinical Decision Support

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kirkenes Legesenter

Kirkenes, Finnmark Fylke, 9915, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pigmented skin lesion

Exclusion criteria

-

Treatment and study plan

Nevus doctor program

Device

The Nevus doctor program supplies a diagnostic category of pigmented skin lesions based on dermatoscopy images.

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. User-friendliness

    Time frame: 6-8 months after enrollment

    Participating GPs are invited to interviews

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • The Research Council of Norway
  • University of Tromso

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2013
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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