<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/NCT02196246</url>
  </required_header>
  <id_info>
    <org_study_id>Protocol-004</org_study_id>
    <nct_id>NCT02196246</nct_id>
  </id_info>
  <brief_title>Moletest Clinical Study in Scotland</brief_title>
  <official_title>A Clinical Study to Evaluate the Ability of an iPad Based Photographic Image Analysis System to Discriminate Benign Skin Lesions From Those Considered Suspect for Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moletest Scotland Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Digital Health &amp; Care Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NHS Lanarkshire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Moletest Scotland Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination&#xD;
      of benign from malignant suspicious skin lesions or moles. Specifically the objective is to&#xD;
      demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to&#xD;
      identify lesions which are benign&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2015</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">October 12, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical accuracy of Moletest application, the combined measured attributes of a suspect legion compared to the outcome of a biopsy performed on the legion</measure>
    <time_frame>6 weeks turnaround for each sample</time_frame>
    <description>The image and analysis by the application are performed within 10 minutes of the patient giving consent to be part of this study. The biopsy that will be used for comarison with the image analysis will be available to the Investigators approximatly 6 weeks later</description>
  </primary_outcome>
  <enrollment type="Actual">1120</enrollment>
  <condition>Melanoma</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Sample of suspect lesion taken for Biopsy, sample is only retained from initial inspection&#xD;
      until Biopsy, not other Biospecimen retention is required&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients referred to the Dermatology Department, Lanarkshire Hospitals for assessment&#xD;
        of suspicious skin lesions are eligible for inclusion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period&#xD;
        to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible&#xD;
        for inclusion in the study. There are no age limits but patients under the age of 18 years&#xD;
        will also have their inclusion subject to parental/guardian consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        There is no exclsion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Freedman</last_name>
    <role>Study Director</role>
    <affiliation>Royal College of Physicians</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NHS Lanarkshire R&amp;D</name>
      <address>
        <city>Airdrie</city>
        <zip>ML6 0JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://moletestuk.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>December 1, 2017</last_update_submitted>
  <last_update_submitted_qc>December 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Moletest Scotland Ltd</investigator_affiliation>
    <investigator_full_name>Girish Gupta</investigator_full_name>
    <investigator_title>Principal Investigator Scientic Advisory Board member</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT02196246
org study id: Protocol-004
nct id: NCT02196246
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination
      of benign from malignant suspicious skin lesions or moles. Specifically the objective is to
      demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to
      identify lesions which are benign
observational model: Case-Control
time perspective: Prospective
measure: Clinical accuracy of Moletest application, the combined measured attributes of a suspect legion compared to the outcome of a biopsy performed on the legion
time frame: 6 weeks turnaround for each sample
description: The image and analysis by the application are performed within 10 minutes of the patient giving consent to be part of this study. The biopsy that will be used for comarison with the image analysis will be available to the Investigators approximatly 6 weeks later
Sample of suspect lesion taken for Biopsy, sample is only retained from initial inspection
      until Biopsy, not other Biospecimen retention is required
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Freedman
role: Study Director
affiliation: Royal College of Physicians
facility: 
country: United Kingdom
url: http://moletestuk.com/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Moletest Scotland Ltd
investigator full name: Girish Gupta
investigator title: Principal Investigator Scientic Advisory Board member
mesh term: Melanoma