Nevus Doctor Clinical Decision Support for GPs

NCT03246412 | Completed

• 1 other identifier: 2013/1793
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma (Skin); Non-melanoma Skin Cancer; Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Skin lesions not classified by GPs

  Up to 3 months

• Biopsies and excisions

  Up to 3 months

Other Outcomes (1)

• User experience

  Up to 12 months.

Study Arms (2)

Nevus doctor clinical decision support

EXPERIMENTAL

The GPs have access to the clinical decision support tool "Nevus doctor".

Diagnostic Test: Nevus doctor clinical decision support

Control

NO INTERVENTION

The GPs have no access to the clinical decision support tool "Nevus Doctor".

Interventions

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.

Nevus doctor clinical decision support

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients not able to give consent

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University Hospital of North-Norway

Tromsø, Troms, 9038, Norway

Location

MeSH Terms

Conditions

Melanoma; Keratosis, Actinic

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas Schopf, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 11, 2017
• Study Start: January 17, 2018
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)