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Nevus Doctor Clinical Decision Support

NCT ID: NCT02012751

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Nevus Melanoma

Keywords

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Computer-assisted diagnosis General practice Dermatoscopy Melanoma Nevus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Nevus doctor program

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

Group Type EXPERIMENTAL

Nevus doctor program

Intervention Type DEVICE

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

Interventions

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Nevus doctor program

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pigmented skin lesion

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tromso

OTHER

Sponsor Role collaborator

The Research Council of Norway

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas R Schopf, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital North-Norway

Locations

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Kirkenes Legesenter

Kirkenes, Finnmark Fylke, Norway

Site Status

Countries

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Norway

Other Identifiers

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2013/1206

Identifier Type: -

Identifier Source: org_study_id