An interventional study of UV Counseling and UV Photo in Nevi and Melanomas, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Prevention
This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's enrollment of 71 is below the median of 120 across 1,197 interventional studies indexed under Behavior.
Browse Behavior studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma.
Behavioral: UV Counseling
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
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
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.
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.
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.
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,
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Start of study to end of study, up to 3 years
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Start of study to end of study, up to 3 years
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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