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Nevus Doctor Clinical Decision Support

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University Hospital of North Norway
Sponsor:
Collaborators:
University of Tromso
The Research Council of Norway
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT02012751
First received: December 4, 2013
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Nevus
Melanoma
Device: Nevus doctor program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Nevus Doctor Clinical Decision Support Program for Pigmented Skin Lesions and Melanoma

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Number of correct test results [ Time Frame: Up to 2 weeks from enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 2 weeks from enrollment ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • User-friendliness [ Time Frame: 6-8 months after enrollment ] [ Designated as safety issue: No ]
    Participating GPs are invited to interviews


Estimated Enrollment: 100
Study Start Date: April 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nevus doctor program
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pigmented skin lesion

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012751

Contacts
Contact: Thomas R Schopf, MD PhD 4791527503 thomas.roger.schopf@telemed.no

Locations
Norway
Kirkenes Legesenter Not yet recruiting
Kirkenes, Finnmark, Norway, 9915
Principal Investigator: Drude Bratlien, MD         
Sponsors and Collaborators
University Hospital of North Norway
University of Tromso
The Research Council of Norway
Investigators
Principal Investigator: Thomas R Schopf, Ph.D. University Hospital North-Norway
  More Information

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02012751     History of Changes
Other Study ID Numbers: 2013/1206
Study First Received: December 4, 2013
Last Updated: March 28, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health

Keywords provided by University Hospital of North Norway:
Computer-assisted diagnosis
General practice
Dermatoscopy
Melanoma
Nevus

Additional relevant MeSH terms:
Melanoma
Nevus
Nevus, Pigmented
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 29, 2014