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

N/ACompletedNCT03783325

University of Colorado, Denver71 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

71

Conditions

Nevi and Melanomas

Interventions

UV CounselingBEHAVIORAL

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.

Biological SampleOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. \> or = 18 years of age 2. 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 Exclusion Criteria: 1\. No exclusion criteria listed

Locations (1)

University of Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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Secondary Outcomes

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

NCT03783325 - Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma | Crick | Crick