<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03246412</url>
  </required_header>
  <id_info>
    <org_study_id>2013/1793</org_study_id>
    <nct_id>NCT03246412</nct_id>
  </id_info>
  <brief_title>Nevus Doctor Clinical Decision Support for GPs</brief_title>
  <official_title>Nevus or Melanoma? Nevus Doctor - Computer Aided Clinical Decision Support in Primary Health Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital of North Norway</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study investigates if a computer-based clinical decision support tool for skin cancer may&#xD;
      improve the diagnostic accuracy of general practitioners (GPs). The aim of the program is to&#xD;
      help GPs increase their diagnostic accuracy, in particular regarding the selection of&#xD;
      suspicious skin lesions that need biopsy or referral to specialist health care for further&#xD;
      assessment. Half of the physicians in the trial will have the clinical decision support tool&#xD;
      available during consultations, while the other half has no such tool available. We&#xD;
      hypothesize that general practitioners using the clinical decision support tool will have a&#xD;
      higher number of correct classifications of skin lesions compared to doctors without the&#xD;
      tool.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      General practitioners (GPs) examine patients who attend a primary health care center. In the&#xD;
      intervention group the computer-based clinical decision support tool &quot;Nevus doctor&quot; in a&#xD;
      first step assists doctors in the process of selecting skin lesions that are suggestive of&#xD;
      cancer. In the next step a given skin lesion is photographed using a dermatoscope attached to&#xD;
      the lens of the camera. The dermatoscopic image is then processed by the computer program&#xD;
      &quot;Nevus doctor&quot; and a preliminary result is presented. Finally the GP reviews the result and&#xD;
      assesses the clinical significance of the output by using guidelines presented by &quot;Nevus&#xD;
      doctor&quot;. The patient is subsequently referred to a dermatologist and a complete skin&#xD;
      examination is performed. The assessment of the dermatologist serves as the gold standard.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 17, 2018</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic classification of suspicious skin lesions</measure>
    <time_frame>Up to 3 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin lesions not classified by GPs</measure>
    <time_frame>Up to 3 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biopsies and excisions</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Skin lesions biopsied or excised by the GP are counted.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>User experience</measure>
    <time_frame>Up to 12 months.</time_frame>
    <description>The GPs are asked to answer a questionnaire to assess the user experiences of operating the clinical decision support tool.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">390</enrollment>
  <condition>Melanoma (Skin)</condition>
  <condition>Non-melanoma Skin Cancer</condition>
  <condition>Actinic Keratoses</condition>
  <arm_group>
    <arm_group_label>Nevus doctor clinical decision support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The GPs have access to the clinical decision support tool &quot;Nevus doctor&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The GPs have no access to the clinical decision support tool &quot;Nevus Doctor&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Nevus doctor clinical decision support</intervention_name>
    <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.</description>
    <arm_group_label>Nevus doctor clinical decision support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients concerned about one or several skin lesion(s)&#xD;
&#xD;
          -  Patients with any other condition if doctor has observed a skin lesion suspicious for&#xD;
             skin cancer (incl. actinic keratosis)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not able to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Schopf, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of North Norway</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Schopf, PhD</last_name>
    <phone>+4791527503</phone>
    <email>thomas.schopf@ehealthresearch.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Monika Johansen, PhD</last_name>
    <phone>+4790684407</phone>
    <email>monika.johansen@ehealthresearch.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital of North-Norway</name>
      <address>
        <city>Tromsø</city>
        <state>Troms</state>
        <zip>9038</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Schopf, PhD</last_name>
      <email>thomas.schopf@ehealthresearch.no</email>
    </contact>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 6, 2018</last_update_submitted>
  <last_update_submitted_qc>August 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Keratosis, Actinic</mesh_term>
    <mesh_term>Keratosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03246412
org study id: 2013/1793
nct id: NCT03246412
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic classification of suspicious skin lesions
time frame: Up to 3 months
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.
measure: Skin lesions not classified by GPs
time frame: Up to 3 months
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.
measure: Biopsies and excisions
time frame: Up to 3 months
description: Skin lesions biopsied or excised by the GP are counted.
measure: User experience
time frame: Up to 12 months.
description: The GPs are asked to answer a questionnaire to assess the user experiences of operating the clinical decision support tool.
arm group label: Nevus doctor clinical decision support
arm group type: Experimental
description: The GPs have access to the clinical decision support tool "Nevus doctor".
arm group label: Control
arm group type: No Intervention
description: The GPs have no access to the clinical decision support tool "Nevus Doctor".
intervention type: Diagnostic Test
intervention name: Nevus doctor clinical decision support
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.
arm group label: Nevus doctor clinical decision support
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: Thomas Schopf, PhD
role: Principal Investigator
affiliation: University Hospital of North Norway
last name: Thomas Schopf, PhD
phone: +4791527503
email: thomas.schopf@ehealthresearch.no
last name: Monika Johansen, PhD
phone: +4790684407
email: monika.johansen@ehealthresearch.no
facility: 
status: Recruiting
contact: 
country: Norway
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Keratosis, Actinic
mesh term: Keratosis
sharing ipd: No