Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma
- Conditions
- Nevi and Melanomas
- Interventions
- Other: UV PhotoBehavioral: UV CounselingOther: Biological Sample
- Registration Number
- NCT03783325
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- > 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
- No exclusion criteria listed
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Visual Analysis - UV Photo 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. UV Counseling UV Counseling Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma. Biological Sample 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.
- Primary Outcome Measures
Name Time Method 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: 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.
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,
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
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.
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: 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, 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: 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: 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.
- Secondary Outcome Measures
Name Time Method 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
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
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
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, 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
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.
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
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, 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
Trial Locations
- Locations (1)
University of Colorado
🇺🇸Aurora, Colorado, United States