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Nevus Doctor Clinical Decision Support for GPs

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Nevus doctor clinical decision support
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Melanoma (Skin)

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of North-NorwayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nevus doctor clinical decision support

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Biopsies and excisions
Skin lesions biopsied or excised by the GP are counted.

Full Information

First Posted
August 8, 2017
Last Updated
August 6, 2018
Sponsor
University Hospital of North Norway
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1. Study Identification

Unique Protocol Identification Number
NCT03246412
Brief Title
Nevus Doctor Clinical Decision Support for GPs
Official Title
Nevus or Melanoma? Nevus Doctor - Computer Aided Clinical Decision Support in Primary Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin), Non-melanoma Skin Cancer, Actinic Keratoses

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nevus doctor clinical decision support
Arm Type
Experimental
Arm Description
The GPs have access to the clinical decision support tool "Nevus doctor".
Arm Title
Control
Arm Type
No Intervention
Arm Description
The GPs have no access to the clinical decision support tool "Nevus Doctor".
Intervention Type
Diagnostic Test
Intervention Name(s)
Nevus doctor clinical decision support
Intervention Description
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 Outcome Measure Information:
Title
Diagnostic classification of suspicious skin lesions
Description
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.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Skin lesions not classified by GPs
Description
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.
Time Frame
Up to 3 months
Title
Biopsies and excisions
Description
Skin lesions biopsied or excised by the GP are counted.
Time Frame
Up to 3 months
Other Pre-specified Outcome Measures:
Title
User experience
Description
The GPs are asked to answer a questionnaire to assess the user experiences of operating the clinical decision support tool.
Time Frame
Up to 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Schopf, PhD
Phone
+4791527503
Email
thomas.schopf@ehealthresearch.no
First Name & Middle Initial & Last Name or Official Title & Degree
Monika Johansen, PhD
Phone
+4790684407
Email
monika.johansen@ehealthresearch.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Schopf, PhD
Organizational Affiliation
University Hospital of North Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of North-Norway
City
Tromsø
State/Province
Troms
ZIP/Postal Code
9038
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Schopf, PhD
Email
thomas.schopf@ehealthresearch.no

12. IPD Sharing Statement

Plan to Share IPD
No

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Nevus Doctor Clinical Decision Support for GPs

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