Clinical trial NCT03783325: Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma
Official title: Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nevi and Melanomas
Keywords: Sun Exposure
UV Dosimetry
Biomarkers
Behaviors
Genetics
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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).
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Sun Exposure Behaviors
timeFrame: Start of study, initial interaction with participants.
measure: UV Exposure Assessment
timeFrame: Start of study to end of study, up to 6 weeks
measure: Visual Appearance Relationships: Melanoma, Questionnaire
timeFrame: Start of study to end of study, up to 3 years
measure: Visual Appearance Relationships: Non-Melanoma , Questionnaire
timeFrame: Start of study to end of study, up to 3 years
measure: Visual Appearance Relationships: Melanoma, Photography
timeFrame: Start of study to end of study, up to 3 years
measure: Visual Appearance Relationships: Non-Melanoma, Photography
timeFrame: Start of study to end of study, up to 3 years
measure: Visual Appearance Relationships: Melanoma, Casting
timeFrame: Start of study to end of study, up to 3 years
measure: Visual Appearance Relationships: Non-Melanoma, Casting
timeFrame: Start of study to end of study, up to 3 years
measure: Visual Appearance Relationships: Melanoma, SCINEXA
timeFrame: Start of study to end of study, up to 3 years
measure: Visual Appearance Relationships: Non-Melanoma, SCINEXA
timeFrame: Start of study to end of study, up to 3 years
measure: Genetics Correlations
timeFrame: Start of study to end of study, up to 3 years
Secondary outcomes:
measure: Self Reporting Behaviors
timeFrame: Start of study to end of study, up to 3 years
measure: Behavioral Intervention and Immediate Follow Up
timeFrame: After wearing dosimetry for 3 weeks
measure: Benign Nevi, DNA
timeFrame: Start of study to end of study, up to 3 years
measure: Benign Nevi, Mutations
timeFrame: Start of study to end of study, up to 3 years
measure: Benign Nevi, Exposure
timeFrame: Start of study to end of study, up to 3 years
measure: Benign Nevi, UV Camera
timeFrame: Start of study to end of study, up to 3 years
measure: Primary Melanomas, DNA
timeFrame: Start of study to end of study, up to 3 years
measure: Primary Melanomas, Mutations
timeFrame: Start of study to end of study, up to 3 years
measure: Primary Melanomas, Exposure
timeFrame: Start of study to end of study, up to 3 years
measure: Primary Melanomas, UV Camera
timeFrame: Start of study to end of study, up to 3 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Neil Box, PhD
role: PRINCIPAL_INVESTIGATOR
References: