An interventional study of Nevus doctor program in Nevus and Melanoma, sponsored by University Hospital of North Norway. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-28.
Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Diagnostic
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.
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.
47 studies on the registry are indexed under Nevus; 9 are open to participants now.
This study's enrollment of 49 is below the median of 100 across 19 interventional studies indexed under Nevus.
Browse Nevus studies →University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
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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.
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.
Time frame: Up to 2 weeks from enrollment
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.
Time frame: Up to 2 weeks from enrollment
User-friendliness
Participating GPs are invited to interviews
Time frame: 6-8 months after enrollment
The record gives a start of Oct 2014, a primary completion of Sep 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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