<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/NCT03783325</url>
  </required_header>
  <id_info>
    <org_study_id>16-1603.cc</org_study_id>
    <nct_id>NCT03783325</nct_id>
  </id_info>
  <brief_title>Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma</brief_title>
  <official_title>Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This research study is designed to better understand the role of genetics, sun-exposure and&#xD;
      phenotypic factors in melanoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 17, 2017</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients will have the opportunity to participate in a questionnaire and then they are given the option to participate in substudy A (wear a UV dosimeter, complete questionnaires, and receive feedback based on the UV dosimeter results), subtstudy B (wear a skin patch, participate in a UV photo analysis, answer questionnaires), and/or substudy C (give biological samples via nevi).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sun Exposure Behaviors</measure>
    <time_frame>Start of study, initial interaction with participants.</time_frame>
    <description>A short questionnaire is administered during the clinic visit to assess sun exposure behaviors of melanoma patients. The data gathered from this questionnaire will help identify possible trends in sun exposure behaviors and provide a baseline dataset for future research,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>UV Exposure Assessment</measure>
    <time_frame>Start of study to end of study, up to 6 weeks</time_frame>
    <description>Identify the difference between self-reported sun exposure behavior and actual UV exposure by having patients wear individual dosimeters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Appearance Relationships: Melanoma, Questionnaire</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a sun exposure questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Appearance Relationships: Non-Melanoma , Questionnaire</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a sun exposure questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Appearance Relationships: Melanoma, Photography</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a UV photography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Appearance Relationships: Non-Melanoma, Photography</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a UV photography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Appearance Relationships: Melanoma, Casting</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a silicone casts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Appearance Relationships: Non-Melanoma, Casting</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a silicone casts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Appearance Relationships: Melanoma, SCINEXA</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a SCINEXA exam.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Appearance Relationships: Non-Melanoma, SCINEXA</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a SCINEXA exam.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genetics Correlations</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine whether UV exposure and camera scores correlates with UV signature (somatic) mutations and other tumor-related mutations in clinically benign nevi and primary melanomas using saliva samples, benign nevi, and primary melanomas. Next Generation Sequencing (NGS) will be used to obtain the genetic information from all samples.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self Reporting Behaviors</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine self-reported sun exposure behaviors through participant interviews. Questions are related to time spent outside, and what attempts to be sun-safe occurred while outside.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral Intervention and Immediate Follow Up</measure>
    <time_frame>After wearing dosimetry for 3 weeks</time_frame>
    <description>Participants will receive a personalized feedback plan and the success of the plan will be measured through individual dosimetry. We will track real time change in sun exposure based on repeat UV dosimetry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benign Nevi, DNA</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of genomic DNA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benign Nevi, Mutations</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of somatic mutations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benign Nevi, Exposure</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV exposure history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benign Nevi, UV Camera</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV camera scores with the clinical presentation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Melanomas, DNA</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of genomic DNA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Melanomas, Mutations</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of somatic mutations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Melanomas, Exposure</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV exposure history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Melanomas, UV Camera</measure>
    <time_frame>Start of study to end of study, up to 3 years</time_frame>
    <description>Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV camera scores with the clinical presentation</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Nevi and Melanomas</condition>
  <arm_group>
    <arm_group_label>UV Counseling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Visual Analysis - UV Photo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assess the relationships between UV camera score, silicone mold of a skin patch, phenotypic evaluation and sun-exposure behaviors. Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biological Sample</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Determine the relationship between measures of sun exposure and genomic characteristics of tumors in melanoma patients. Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>UV Counseling</intervention_name>
    <description>This is a sub-study that involves a behavioral intervention. Participants will wear a UV dosimetry for 3 weeks, return the device and receive feedback. After the feedback, they will re-wear the device for an additional 3 weeks.</description>
    <arm_group_label>UV Counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>UV Photo</intervention_name>
    <description>Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.</description>
    <arm_group_label>Visual Analysis - UV Photo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biological Sample</intervention_name>
    <description>Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.</description>
    <arm_group_label>Biological Sample</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt; or = 18 years of age&#xD;
&#xD;
          2. Patient at the University of Colorado Anschutz Medical Campus Cutaneous Oncology&#xD;
             Clinic or Dermatology Clinic OR attend the fundraising event of the Colorado Melanoma&#xD;
             Foundation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. No exclusion criteria listed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil Box, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sarah Roberts</last_name>
    <phone>303-724-3912</phone>
    <email>sarah.roberts@ucdenver.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Roberts</last_name>
      <phone>303-724-3912</phone>
      <email>sarah.roberts@ucdenver.edu</email>
    </contact>
    <investigator>
      <last_name>Neil Box, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sun Exposure</keyword>
  <keyword>UV Dosimetry</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Behaviors</keyword>
  <keyword>Genetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Nevus</mesh_term>
    <mesh_term>Nevi and Melanomas</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/NCT03783325
org study id: 16-1603.cc
nct id: NCT03783325
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research study is designed to better understand the role of genetics, sun-exposure and
      phenotypic factors in melanoma.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Patients will have the opportunity to participate in a questionnaire and then they are given the option to participate in substudy A (wear a UV dosimeter, complete questionnaires, and receive feedback based on the UV dosimeter results), subtstudy B (wear a skin patch, participate in a UV photo analysis, answer questionnaires), and/or substudy C (give biological samples via nevi).
primary purpose: Prevention
masking: None (Open Label)
measure: Sun Exposure Behaviors
time frame: Start of study, initial interaction with participants.
description: A short questionnaire is administered during the clinic visit to assess sun exposure behaviors of melanoma patients. The data gathered from this questionnaire will help identify possible trends in sun exposure behaviors and provide a baseline dataset for future research,
measure: UV Exposure Assessment
time frame: Start of study to end of study, up to 6 weeks
description: Identify the difference between self-reported sun exposure behavior and actual UV exposure by having patients wear individual dosimeters
measure: Visual Appearance Relationships: Melanoma, Questionnaire
time frame: Start of study to end of study, up to 3 years
description: Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a sun exposure questionnaire
measure: Visual Appearance Relationships: Non-Melanoma , Questionnaire
time frame: Start of study to end of study, up to 3 years
description: Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a sun exposure questionnaire
measure: Visual Appearance Relationships: Melanoma, Photography
time frame: Start of study to end of study, up to 3 years
description: Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a UV photography
measure: Visual Appearance Relationships: Non-Melanoma, Photography
time frame: Start of study to end of study, up to 3 years
description: Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a UV photography
measure: Visual Appearance Relationships: Melanoma, Casting
time frame: Start of study to end of study, up to 3 years
description: Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a silicone casts
measure: Visual Appearance Relationships: Non-Melanoma, Casting
time frame: Start of study to end of study, up to 3 years
description: Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a silicone casts
measure: Visual Appearance Relationships: Melanoma, SCINEXA
time frame: Start of study to end of study, up to 3 years
description: Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a SCINEXA exam.
measure: Visual Appearance Relationships: Non-Melanoma, SCINEXA
time frame: Start of study to end of study, up to 3 years
description: Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a SCINEXA exam.
measure: Genetics Correlations
time frame: Start of study to end of study, up to 3 years
description: Determine whether UV exposure and camera scores correlates with UV signature (somatic) mutations and other tumor-related mutations in clinically benign nevi and primary melanomas using saliva samples, benign nevi, and primary melanomas. Next Generation Sequencing (NGS) will be used to obtain the genetic information from all samples.
measure: Self Reporting Behaviors
time frame: Start of study to end of study, up to 3 years
description: Determine self-reported sun exposure behaviors through participant interviews. Questions are related to time spent outside, and what attempts to be sun-safe occurred while outside.
measure: Behavioral Intervention and Immediate Follow Up
time frame: After wearing dosimetry for 3 weeks
description: Participants will receive a personalized feedback plan and the success of the plan will be measured through individual dosimetry. We will track real time change in sun exposure based on repeat UV dosimetry.
measure: Benign Nevi, DNA
time frame: Start of study to end of study, up to 3 years
description: Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of genomic DNA
measure: Benign Nevi, Mutations
time frame: Start of study to end of study, up to 3 years
description: Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of somatic mutations
measure: Benign Nevi, Exposure
time frame: Start of study to end of study, up to 3 years
description: Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV exposure history
measure: Benign Nevi, UV Camera
time frame: Start of study to end of study, up to 3 years
description: Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV camera scores with the clinical presentation
measure: Primary Melanomas, DNA
time frame: Start of study to end of study, up to 3 years
description: Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of genomic DNA
measure: Primary Melanomas, Mutations
time frame: Start of study to end of study, up to 3 years
description: Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of somatic mutations
measure: Primary Melanomas, Exposure
time frame: Start of study to end of study, up to 3 years
description: Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV exposure history
measure: Primary Melanomas, UV Camera
time frame: Start of study to end of study, up to 3 years
description: Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV camera scores with the clinical presentation
arm group label: UV Counseling
arm group type: Other
description: Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma.
arm group label: Visual Analysis - UV Photo
arm group type: Experimental
description: Assess the relationships between UV camera score, silicone mold of a skin patch, phenotypic evaluation and sun-exposure behaviors. Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.
arm group label: Biological Sample
arm group type: Experimental
description: Determine the relationship between measures of sun exposure and genomic characteristics of tumors in melanoma patients. Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.
intervention type: Behavioral
intervention name: UV Counseling
description: This is a sub-study that involves a behavioral intervention. Participants will wear a UV dosimetry for 3 weeks, return the device and receive feedback. After the feedback, they will re-wear the device for an additional 3 weeks.
arm group label: UV Counseling
intervention type: Other
intervention name: UV Photo
description: Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.
arm group label: Visual Analysis - UV Photo
intervention type: Other
intervention name: Biological Sample
description: Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.
arm group label: Biological Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Neil Box, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Sarah Roberts
phone: 303-724-3912
email: sarah.roberts@ucdenver.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Nevus
mesh term: Nevi and Melanomas