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This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UV Counseling | Other | Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma. |
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| Visual Analysis - UV Photo | Experimental | 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. |
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| Biological Sample | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UV Counseling | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. No exclusion criteria listed
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| Name | Affiliation | Role |
|---|---|---|
| Neil Box, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D018326 | Nevi and Melanomas |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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).
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| UV Photo | Other | 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. |
|
| Biological Sample | Other | 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. |
|
| 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 |
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 |