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

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

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

Conditions
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Nevi and Melanomas

Intervention / Treatment
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* Behavioral: UV Counseling
* Other: UV Photo
* Other: Biological Sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > or = 18 years of age 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: UV Counseling<br>Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma. | Behavioral: UV Counseling<br>* 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.<br>|
| Experimental: Visual Analysis - UV Photo<br>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<br>* 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.<br>|
| Experimental: Biological Sample<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sun Exposure Behaviors | 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, | Start of study, initial interaction with participants. | 
| UV Exposure Assessment | Identify the difference between self-reported sun exposure behavior and actual UV exposure by having patients wear individual dosimeters | Start of study to end of study, up to 6 weeks | 
| Visual Appearance Relationships: Melanoma, Questionnaire | Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a sun exposure questionnaire | Start of study to end of study, up to 3 years | 
| Visual Appearance Relationships: Non-Melanoma , Questionnaire | Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a sun exposure questionnaire | Start of study to end of study, up to 3 years | 
| Visual Appearance Relationships: Melanoma, Photography | Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a UV photography | Start of study to end of study, up to 3 years | 
| Visual Appearance Relationships: Non-Melanoma, Photography | Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a UV photography | Start of study to end of study, up to 3 years | 
| Visual Appearance Relationships: Melanoma, Casting | Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a silicone casts | Start of study to end of study, up to 3 years | 
| Visual Appearance Relationships: Non-Melanoma, Casting | Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a silicone casts | Start of study to end of study, up to 3 years | 
| Visual Appearance Relationships: Melanoma, SCINEXA | Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a SCINEXA exam. | Start of study to end of study, up to 3 years | 
| Visual Appearance Relationships: Non-Melanoma, SCINEXA | Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a SCINEXA exam. | Start of study to end of study, up to 3 years | 
| Genetics Correlations | 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. | Start of study to end of study, up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Reporting Behaviors | 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. | Start of study to end of study, up to 3 years | 
| Behavioral Intervention and Immediate Follow Up | 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. | After wearing dosimetry for 3 weeks | 
| Benign Nevi, DNA | Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of genomic DNA | Start of study to end of study, up to 3 years | 
| Benign Nevi, Mutations | Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of somatic mutations | Start of study to end of study, up to 3 years | 
| Benign Nevi, Exposure | Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV exposure history | Start of study to end of study, up to 3 years | 
| Benign Nevi, UV Camera | Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV camera scores with the clinical presentation | Start of study to end of study, up to 3 years | 
| Primary Melanomas, DNA | Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of genomic DNA | Start of study to end of study, up to 3 years | 
| Primary Melanomas, Mutations | Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of somatic mutations | Start of study to end of study, up to 3 years | 
| Primary Melanomas, Exposure | Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV exposure history | Start of study to end of study, up to 3 years | 
| Primary Melanomas, UV Camera | Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV camera scores with the clinical presentation | Start of study to end of study, up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sun Exposure, UV Dosimetry, Biomarkers, Behaviors, Genetics