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Completed

NCT Number: NCT03246412

Nevus Doctor Clinical Decision Support for GPs

The study investigates if a computer-based clinical decision support tool for skin cancer may improve the diagnostic accuracy of general practitioners (GPs). The aim of the program is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious skin lesions that need biopsy or referral to specialist health care for further assessment. Half of the physicians in the trial will have the clinical decision support tool available during consultations, while the other half has no such tool available. We hypothesize that general practitioners using the clinical decision support tool will have a higher number of correct classifications of skin lesions compared to doctors without the tool.

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Key information

Conditions

Melanoma (Skin) Actinic Keratoses Keratosis Keratosis, Actinic Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-Melanoma Skin Cancer Precancerous Conditions Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North-Norway

Tromsø, Troms, 9038, Norway

About this study

General practitioners (GPs) examine patients who attend a primary health care center. In the intervention group the computer-based clinical decision support tool "Nevus doctor" in a first step assists doctors in the process of selecting skin lesions that are suggestive of cancer. In the next step a given skin lesion is photographed using a dermatoscope attached to the lens of the camera. The dermatoscopic image is then processed by the computer program "Nevus doctor" and a preliminary result is presented. Finally the GP reviews the result and assesses the clinical significance of the output by using guidelines presented by "Nevus doctor". The patient is subsequently referred to a dermatologist and a complete skin examination is performed. The assessment of the dermatologist serves as the gold standard.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients concerned about one or several skin lesion(s)
  • Patients with any other condition if doctor has observed a skin lesion suspicious for skin cancer (incl. actinic keratosis)

Exclusion criteria

  • Patients not able to give consent

Treatment and study plan

Nevus doctor clinical decision support

Diagnostic Test

The computer program analyzes dermatoscopic images. The output is an estimate of the risk of the skin lesion representing skin cancer. The decision support tool helps the doctor to assess the significance of the computer output by taking into account clinical information.

Primary outcomes

  1. Diagnostic classification of suspicious skin lesions

    Time frame: Up to 3 months

    Skin lesions selected by the GP are classified into three classes: 1 Not suspicious for skin cancer, 2 Somewhat suspicious for skin cancer, 3 Very suspicious for skin cancer. The reference standard is the specialist's classification. The number of correct classifications are counted. Sensitivity and specificity scores are calculated.

Secondary outcomes

  1. Skin lesions not classified by GPs

    Time frame: Up to 3 months

    Skin lesions that were not selected by the GP but were later classified by the specialist to be suspicious for skin cancer or very suspicious for skin cancer are counted.

  2. Biopsies and excisions

    Time frame: Up to 3 months

    Skin lesions biopsied or excised by the GP are counted.

Other outcomes

  1. User experience

    Time frame: Up to 12 months.

    The GPs are asked to answer a questionnaire to assess the user experiences of operating the clinical decision support tool.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

Nevus or Melanoma? Nevus Doctor - Computer Aided Clinical Decision Support in Primary Health Care

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2017
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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