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Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma

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ClinicalTrials.gov Identifier: NCT03783325
Recruitment Status : Completed
First Posted : December 21, 2018
Last Update Posted : October 23, 2023
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.

Condition or disease Intervention/treatment Phase
Nevi and Melanomas Behavioral: UV Counseling Other: UV Photo Other: Biological Sample Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
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).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma
Actual Study Start Date : February 17, 2017
Actual Primary Completion Date : June 17, 2022
Actual Study Completion Date : June 17, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
UV Counseling
Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma.
 Behavioral: UV Counseling
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.
Experimental: Visual Analysis - UV Photo
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.
 Other: UV Photo
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.
Experimental: Biological Sample
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.
 Other: Biological Sample
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.


Outcome Measures
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Primary Outcome Measures :
  1. Sun Exposure Behaviors [ Time Frame: Start of study, initial interaction with participants. ]
    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,

  2. UV Exposure Assessment [ Time Frame: Start of study to end of study, up to 6 weeks ]
    Identify the difference between self-reported sun exposure behavior and actual UV exposure by having patients wear individual dosimeters

  3. Visual Appearance Relationships: Melanoma, Questionnaire [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a sun exposure questionnaire

  4. Visual Appearance Relationships: Non-Melanoma , Questionnaire [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a sun exposure questionnaire

  5. Visual Appearance Relationships: Melanoma, Photography [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a UV photography

  6. Visual Appearance Relationships: Non-Melanoma, Photography [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a UV photography

  7. Visual Appearance Relationships: Melanoma, Casting [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a silicone casts

  8. Visual Appearance Relationships: Non-Melanoma, Casting [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a silicone casts

  9. Visual Appearance Relationships: Melanoma, SCINEXA [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a SCINEXA exam.

  10. Visual Appearance Relationships: Non-Melanoma, SCINEXA [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a SCINEXA exam.

  11. Genetics Correlations [ Time Frame: Start of study to end of study, up to 3 years ]
    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.


Secondary Outcome Measures :
  1. Self Reporting Behaviors [ Time Frame: Start of study to end of study, up to 3 years ]
    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.

  2. Behavioral Intervention and Immediate Follow Up [ Time Frame: After wearing dosimetry for 3 weeks ]
    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.

  3. Benign Nevi, DNA [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of genomic DNA

  4. Benign Nevi, Mutations [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of somatic mutations

  5. Benign Nevi, Exposure [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV exposure history

  6. Benign Nevi, UV Camera [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV camera scores with the clinical presentation

  7. Primary Melanomas, DNA [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of genomic DNA

  8. Primary Melanomas, Mutations [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of somatic mutations

  9. Primary Melanomas, Exposure [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV exposure history

  10. Primary Melanomas, UV Camera [ Time Frame: Start of study to end of study, up to 3 years ]
    Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV camera scores with the clinical presentation


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. > or = 18 years of age
  2. Patient at the University of Colorado Anschutz Medical Campus Cutaneous Oncology Clinic or Dermatology Clinic OR attend the fundraising event of the Colorado Melanoma Foundation

Exclusion Criteria:

1. No exclusion criteria listed

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783325


Locations
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United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Neil Box, PhD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03783325    
Other Study ID Numbers: 16-1603.cc
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: October 23, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Sun Exposure
UV Dosimetry
Biomarkers
Behaviors
Genetics
Additional relevant MeSH terms:
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Melanoma
Nevus
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Skin Neoplasms
Neoplasms by Site
Skin Diseases