Nevus Doctor Clinical Decision Support for GPs

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246412
• Other study ID #: 2013/1793
• Status: Completed
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: December 12, 2019

Study information

• Verified date: March 2024
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic
• Melanoma
• Melanoma (Skin)
• Non-melanoma Skin Cancer

Intervention

Diagnostic Test:
• Nevus doctor clinical decision support
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.

Locations

Country	Name	City	State
Norway	University Hospital of North-Norway	Tromsø	Troms

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User experience	The GPs are asked to answer a questionnaire to assess the user experiences of operating the clinical decision support tool.	Up to 12 months.
Primary	Diagnostic classification of suspicious skin lesions	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.	Up to 3 months
Secondary	Skin lesions not classified by GPs	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.	Up to 3 months
Secondary	Biopsies and excisions	Skin lesions biopsied or excised by the GP are counted.	Up to 3 months