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

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

Study Overview

• Status: Completed
• Conditions: Nevi and Melanomas
• Intervention / Treatment: Behavioral: UV Counseling; Other: UV Photo; Other: Biological Sample

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: UV Counseling; Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma.	Behavioral: UV Counseling; 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.
Experimental: Visual Analysis - UV Photo; 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; 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.
Experimental: Biological Sample; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,	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	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	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	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	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	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	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	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.	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.	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.	Start of study to end of study, up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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	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	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	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	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	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	Start of study to end of study, up to 3 years

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Neil Box, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2017
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): June 17, 2022

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Genetics; Biomarkers; Sun Exposure; UV Dosimetry; Behaviors
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Melanoma; Nevus; Nevi and Melanomas
• Other Study ID Numbers: 16-1603.cc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No