<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/NCT02221843</url>
  </required_header>
  <id_info>
    <org_study_id>KEK2013-0283_Sunbit</org_study_id>
    <nct_id>NCT02221843</nct_id>
  </id_info>
  <brief_title>Sunbit UV Measuring Device to Track Sun Behavior</brief_title>
  <official_title>An Observational Single Center Pilot Study Using a Wearable UV Sensor (Sunbit) Measuring UV Exposure of Patients at High Risk for Skin Cancer - SUNBIT Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sunbit is a new wearable UV dosimeter to measure solar radiation in real time. The purpose of&#xD;
      this study is to track sun behavior of patients at high risk for skin cancer, to investigate&#xD;
      the feasibility of this prototype in daily life and to investigate the technical accuracy of&#xD;
      the Sunbit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 20 patients will be included to wear the Sunbit system during the time of 4 weeks.&#xD;
      After this 4 weeks Sunbit will be recollected and data in the form of UV Indices will be&#xD;
      extracted and analyzed.&#xD;
&#xD;
      Patients will be recruited in the Department of Dermatology of the University Hospital&#xD;
      Zürich. The target population comprises patients with a high risk of melanoma and&#xD;
      non-melanoma skin cancer, thus especially patients with an immunosuppressive therapy due to&#xD;
      organ transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Company dissolved, no study devices available anymore&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>number of days wearing the device</measure>
    <time_frame>after 4 weeks wearing the device</time_frame>
    <description>patient compliance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>difference between measured UV Indices and reference values</measure>
    <time_frame>after 4 weeks wearing the device</time_frame>
    <description>technical accuracy of the device</description>
  </secondary_outcome>
  <other_outcome>
    <measure>difference between the individual UV Indices</measure>
    <time_frame>after 4 weeks wearing the device</time_frame>
    <description>sun behavior</description>
  </other_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Immunosuppression</condition>
  <condition>Skin Neoplasms</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Department of Dermatology of the University Hospital Zurich&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  History of skin cancer (melanoma or NMSC) or patients with high risk of skin cancer&#xD;
             (e.g. immunosuppressive therapy)&#xD;
&#xD;
          -  Oral and written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical condition that renders the patient bedridden for the duration of 2 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Günther Hofbauer, Prof. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Dermatology of the University Hospital Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Dermatology of the University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.tik.ee.ethz.ch/file/0be29fd9c90eabb3b0772f37535ef29b/ubicomp11_237.pdf.</url>
    <description>Fahrni, T. Sundroid (renamed Sunbit): Solar Radiation Awareness with Smartphones. 2011</description>
  </link>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>July 11, 2016</last_update_submitted>
  <last_update_submitted_qc>July 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sun behavior</keyword>
  <keyword>immunosuppression</keyword>
  <keyword>skin neoplasms</keyword>
  <keyword>sunbit</keyword>
  <keyword>uv sensor</keyword>
  <keyword>uv dosimeter</keyword>
  <keyword>solar radiation</keyword>
  <keyword>uv exposition</keyword>
  <keyword>uv index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>none intended</ipd_description>
  </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/NCT02221843
org study id: KEK2013-0283_Sunbit
nct id: NCT02221843
lead sponsor: 
has dmc: No
Sunbit is a new wearable UV dosimeter to measure solar radiation in real time. The purpose of
      this study is to track sun behavior of patients at high risk for skin cancer, to investigate
      the feasibility of this prototype in daily life and to investigate the technical accuracy of
      the Sunbit.
A total of 20 patients will be included to wear the Sunbit system during the time of 4 weeks.
      After this 4 weeks Sunbit will be recollected and data in the form of UV Indices will be
      extracted and analyzed.

      Patients will be recruited in the Department of Dermatology of the University Hospital
      Zürich. The target population comprises patients with a high risk of melanoma and
      non-melanoma skin cancer, thus especially patients with an immunosuppressive therapy due to
      organ transplantation.
observational model: Cohort
time perspective: Prospective
measure: number of days wearing the device
time frame: after 4 weeks wearing the device
description: patient compliance
measure: difference between measured UV Indices and reference values
time frame: after 4 weeks wearing the device
description: technical accuracy of the device
measure: difference between the individual UV Indices
time frame: after 4 weeks wearing the device
description: sun behavior
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Günther Hofbauer, Prof. MD
role: Principal Investigator
affiliation: Department of Dermatology of the University Hospital Zurich
facility: 
country: Switzerland
url: http://www.tik.ee.ethz.ch/file/0be29fd9c90eabb3b0772f37535ef29b/ubicomp11_237.pdf.
description: Fahrni, T. Sundroid (renamed Sunbit): Solar Radiation Awareness with Smartphones. 2011
responsible party type: Sponsor
mesh term: Skin Neoplasms
sharing ipd: No
ipd description: none intended