search
Back to results

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

Primary Purpose

Nevi and Melanomas

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UV Counseling
UV Photo
Biological Sample
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nevi and Melanomas focused on measuring Sun Exposure, UV Dosimetry, Biomarkers, Behaviors, Genetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

UV Counseling

Visual Analysis - UV Photo

Biological Sample

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Benign Nevi, DNA
Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of genomic DNA
Benign Nevi, Mutations
Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of somatic mutations
Benign Nevi, Exposure
Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV exposure history
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
Primary Melanomas, DNA
Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of genomic DNA
Primary Melanomas, Mutations
Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of somatic mutations
Primary Melanomas, Exposure
Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV exposure history
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

Full Information

First Posted
December 13, 2018
Last Updated
October 19, 2023
Sponsor
University of Colorado, Denver
search

1. Study Identification

Unique Protocol Identification Number
NCT03783325
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
June 17, 2022 (Actual)
Study Completion Date
June 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nevi and Melanomas
Keywords
Sun Exposure, UV Dosimetry, Biomarkers, Behaviors, Genetics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UV Counseling
Arm Type
Other
Arm Description
Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma.
Arm Title
Visual Analysis - UV Photo
Arm Type
Experimental
Arm Description
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.
Arm Title
Biological Sample
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
UV Counseling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
UV Photo
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Biological Sample
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sun Exposure Behaviors
Description
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.
Title
UV Exposure Assessment
Description
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
Title
Visual Appearance Relationships: Melanoma, Questionnaire
Description
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
Title
Visual Appearance Relationships: Non-Melanoma , Questionnaire
Description
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
Title
Visual Appearance Relationships: Melanoma, Photography
Description
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
Title
Visual Appearance Relationships: Non-Melanoma, Photography
Description
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
Title
Visual Appearance Relationships: Melanoma, Casting
Description
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a silicone casts
Time Frame
Start of study to end of study, up to 3 years
Title
Visual Appearance Relationships: Non-Melanoma, Casting
Description
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a silicone casts
Time Frame
Start of study to end of study, up to 3 years
Title
Visual Appearance Relationships: Melanoma, SCINEXA
Description
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a SCINEXA exam.
Time Frame
Start of study to end of study, up to 3 years
Title
Visual Appearance Relationships: Non-Melanoma, SCINEXA
Description
Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a SCINEXA exam.
Time Frame
Start of study to end of study, up to 3 years
Title
Genetics Correlations
Description
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.
Time Frame
Start of study to end of study, up to 3 years
Secondary Outcome Measure Information:
Title
Self Reporting Behaviors
Description
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
Title
Behavioral Intervention and Immediate Follow Up
Description
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
Title
Benign Nevi, DNA
Description
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
Title
Benign Nevi, Mutations
Description
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
Title
Benign Nevi, Exposure
Description
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
Title
Benign Nevi, UV Camera
Description
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
Title
Primary Melanomas, DNA
Description
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
Title
Primary Melanomas, Mutations
Description
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
Title
Primary Melanomas, Exposure
Description
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
Title
Primary Melanomas, UV Camera
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: > or = 18 years of age 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Box, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs