Nevi and Melanomas
Conditions
Keywords
Sun Exposure, UV Dosimetry, Biomarkers, Behaviors, Genetics
Brief summary
This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.
Interventions
BEHAVIORALUV 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.
OTHERUV 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.
OTHERBiological 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genetics Correlations | 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. |
| Sun Exposure Behaviors | 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, |
| UV Exposure Assessment | 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 |
| Visual Appearance Relationships: Melanoma, Questionnaire | 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 |
| Visual Appearance Relationships: Non-Melanoma , Questionnaire | 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 |
| Visual Appearance Relationships: Melanoma, Photography | 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 |
| Visual Appearance Relationships: Non-Melanoma, Photography | 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 |
| Visual Appearance Relationships: Melanoma, Casting | 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 |
| Visual Appearance Relationships: Non-Melanoma, Casting | 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 |
| Visual Appearance Relationships: Melanoma, SCINEXA | 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. |
| Visual Appearance Relationships: Non-Melanoma, SCINEXA | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Intervention and Immediate Follow Up | 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. |
| Benign Nevi, DNA | 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 |
| Benign Nevi, Mutations | 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 |
| Benign Nevi, Exposure | 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 |
| Benign Nevi, UV Camera | 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 |
| Primary Melanomas, DNA | 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 |
| Primary Melanomas, Mutations | 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 |
| Primary Melanomas, Exposure | 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 |
| Primary Melanomas, UV Camera | 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 |
| Self Reporting Behaviors | 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. |
Countries
United States
Outcome results
None listed