Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Skin Neoplasms

Skin Diseases

UV Dosimeter will measure participants' UV exposure for two separate 3-week periods.

Participants will self-report their knowledge and attitudes related to UV exposure. They will then wear a dosimeter for 3 weeks. After, the study team will counsel the participants on their UV levels and exposure, creating a personal plan and advice for avoiding sun exposure before letting the participants wear the dosimeter for an additional 3 weeks.

UV Counseling

Myles Cockburn, PhD

This study aims to characterize UV exposures among NMSC patients (those with a history of skin cancer) and to pilot an innovative behavioral intervention to decrease modifiable UV exposures. It will use UV dosimeters to objectively measure UV exposure and provide time and activity specific UV data on an individual level. These data will be used to develop a targeted and personalized behavioral feedback plan with counseling aimed at effective sun exposure behavior change

The study will focus on helping to prevent NMSC and its associated morbidity through learning when patients are unintentionally exposed to extreme UV radiation. It will then help to create manageable and realistic behavioral interventions to reduce exposure, while also educating patients of the dangers of abundant sun exposure.

Each participant will self-report skin protective behaviors and attitudes before wearing a UV dosimeter for 3 weeks. After the wear period, the study team provides feedback based on UV exposure. The participant will then wear the device again for 3 weeks.

UV Dosimetry Feedback in NMSC Patients

UV Dosimetry Feedback in Non-Melanoma Skin Cancer Patients

Measured using individual dosimeters and comparing it to what participants state they believe their level of sun exposure is

Compare specific sun exposure behaviors responsible for the level of exposure versus what could be done to lessen it

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.

Track the longitudinal change in sun exposure comparing baseline UV dosimetry measurements to 3 month follow up dosimetry measurements to determine if the changes observed in outcome 3 are maintained.

University of Colorado, Denver

Rare Diseases

Melanoma

Nevus, Pigmented

Nevus

Nevi and Melanomas

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma.

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.

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.

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.

UV Photo

Biological Sample

Neil Box, PhD

This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.

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).

Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma

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,

Identify the difference between self-reported sun exposure behavior and actual UV exposure by having patients wear individual dosimeters

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a sun exposure 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

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a UV photography

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a UV photography

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a silicone casts

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a silicone casts

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a SCINEXA exam.

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a SCINEXA exam.

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.

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.

Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of genomic DNA

Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of somatic mutations

Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV exposure history

Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV camera scores with the clinical presentation

Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of genomic DNA

Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of somatic mutations

Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV exposure history

Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV camera scores with the clinical presentation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
UV Dosimetry Feedback in NMSC Patients	NCT03757663	Non-Melanoma Sk...	UV Counseling	18 Years - 50 Years	University of Colorado, Denver
Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma	NCT03783325	Nevi and Melano...	UV Counseling UV Photo Biological Samp...	18 Years -	University of Colorado, Denver
Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma	NCT03783325	Nevi and Melano...	UV Counseling UV Photo Biological Samp...	18 Years -	University of Colorado, Denver

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