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Nevus Doctor Clinical Decision Support

Primary Purpose

Nevus, Melanoma

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Nevus doctor program
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nevus focused on measuring Computer-assisted diagnosis, General practice, Dermatoscopy, Melanoma, Nevus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pigmented skin lesion

Exclusion Criteria:

-

Sites / Locations

  • Kirkenes Legesenter

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nevus doctor program

Arm Description

Use of Nevus doctor program to assess the diagnostic category of pigmented skin lesions

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 4, 2013
Last Updated
October 27, 2016
Sponsor
University Hospital of North Norway
Collaborators
University of Tromso, The Research Council of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT02012751
Brief Title
Nevus Doctor Clinical Decision Support
Official Title
Nevus Doctor Clinical Decision Support Program for Pigmented Skin Lesions and Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
University of Tromso, The Research Council of Norway

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nevus, Melanoma
Keywords
Computer-assisted diagnosis, General practice, Dermatoscopy, Melanoma, Nevus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nevus doctor program
Arm Type
Experimental
Arm Description
Use of Nevus doctor program to assess the diagnostic category of pigmented skin lesions
Intervention Type
Device
Intervention Name(s)
Nevus doctor program
Intervention Description
The Nevus doctor program supplies a diagnostic category of pigmented skin lesions based on dermatoscopy images.
Primary Outcome Measure Information:
Title
Number of correct test results
Description
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
Secondary Outcome Measure Information:
Title
Patterns regarding false test results
Description
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
Other Pre-specified Outcome Measures:
Title
User-friendliness
Description
Participating GPs are invited to interviews
Time Frame
6-8 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pigmented skin lesion Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R Schopf, Ph.D.
Organizational Affiliation
University Hospital North-Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kirkenes Legesenter
City
Kirkenes
State/Province
Finnmark
ZIP/Postal Code
9915
Country
Norway

12. IPD Sharing Statement

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Nevus Doctor Clinical Decision Support

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