The purpose of this trial is to measure the amount of ultraviolet (UV) radiation a person may receive. Invisible rays that are part of the energy that comes from the sun are called UV radiation. It is known that a form of skin cancer called melanoma is related to skin damage caused by UV exposure, but it is not fully understood which types of UV cause which types of skin damage. This trial also studies the gene-environment interactions in participants with or without melanoma or nevi. Measuring the amount of an individual’s ultraviolet (UV) exposure may help doctors to develop better strategies to protect the public from melanoma, understanding how different measures of sun exposure history may tell doctors more about this risk for melanoma, and studying the correlation between UV exposure and genetic risk factors may help doctors to know whether UV light might induce genetic changes related to cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03783325.
PRIMARY OBJECTIVES:
I. Understand the role of sun exposure behavior in individuals with and without melanoma.
II. Determine which biomarkers and physical characteristics of the skin best describe melanoma severity and progression.
III. Determine current sun exposure behaviors from melanoma patients using UV dosimetry and provide feedback on how they can best avoid sun exposure.
IV. Identify patients who are willing to be contacted for recruitment for other studies in future.
V. Identify the difference between self-reported sun exposure behavior and actual UV exposure by individual dosimeters and specific sun exposure behaviors responsible for that difference. (Sub-study A)
VI. Counsel patients on safe sun exposure behaviors from UV dosimeter readings at baseline. (Sub-study A)
VII. Assess changes in sun-exposure behaviors after personalized feedback. (Sub-study A)
VIII. To determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients and normal subjects. (Sub-study B)
IX. To 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. (Sub-study C)
X. To determine how UV exposure, somatic mutations, and genomic deoxyribonucleic acid (DNA) impact the clinical presentation of benign nevi. (Sub-study C)
XI. To determine how UV exposure, somatic mutations, and genomic DNA interact with one another and impact the presentation of melanomas. (Sub-study C)
OUTLINE: Participants are assigned to 1 of 3 sub-studies.
Sub-Study A: Participants wear UV dosimeter over two, 3-week periods for a total of 6 weeks.
Sub-Study B: Participants undergo UV photography and have a silicone mold taken of the back of the hand over 15-30 minutes.
Sub-Study C: Participants undergo collection of saliva/buccal sample and donate at least 1 mole via shave biopsy, punch biopsy, or excisional biopsy over 1-2 hours. Samples are analyzed via next generation sequencing.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorNeil Box
