Nevus Doctor Clinical Decision Support

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012751
• Other study ID #: 2013/1206
• Status: Completed
• Phase: N/A
• First received: December 4, 2013
• Last updated: October 27, 2016
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: June 2016
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Directorate of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pigmented skin lesion

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Melanoma
• Nevus

Intervention

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

Locations

Country	Name	City	State
Norway	Kirkenes Legesenter	Kirkenes	Finnmark

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital of North Norway	The Research Council of Norway, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User-friendliness	Participating GPs are invited to interviews	6-8 months after enrollment	No
Primary	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	No
Secondary	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	No