Nevus Doctor Clinical Decision Support

NCT02012751 | Completed

• 1 other identifier: 2013/1206
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Nevus; Melanoma

Keywords

Computer-assisted diagnosis; General practice; Dermatoscopy; Melanoma; Nevus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Patterns regarding false test results

  Up to 2 weeks from enrollment

Other Outcomes (1)

• User-friendliness

  6-8 months after enrollment

Study Arms (1)

Nevus doctor program

EXPERIMENTAL

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

Device: Nevus doctor program

Interventions

Nevus doctor program DEVICE

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

Nevus doctor program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pigmented skin lesion

Sponsors & Collaborators

• University Hospital of North Norway: lead
• University of Tromso: collaborator
• The Research Council of Norway: collaborator

Study Sites (1)

Kirkenes Legesenter

Kirkenes, Finnmark Fylke, 9915, Norway

Location

MeSH Terms

Conditions

Nevus; Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas R Schopf, Ph.D.

  University Hospital North-Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 16, 2013
• Study Start: October 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 28, 2016

Record last verified: 2016-06

Locations

NO (1)