Skip to main content
Clinical Trials/NCT03783325
NCT03783325
Completed
Not Applicable

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

University of Colorado, Denver1 site in 1 country71 target enrollmentFebruary 17, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nevi and Melanomas
Sponsor
University of Colorado, Denver
Enrollment
71
Locations
1
Primary Endpoint
UV Exposure Assessment
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 17, 2017
End Date
June 17, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

  • No exclusion criteria listed

Outcomes

Primary Outcomes

UV Exposure Assessment

Time Frame: Start of study to end of study, up to 6 weeks

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

Visual Appearance Relationships: Non-Melanoma, SCINEXA

Time Frame: Start of study to end of study, up to 3 years

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

Sun Exposure Behaviors

Time Frame: Start of study, initial interaction with participants.

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,

Visual Appearance Relationships: Non-Melanoma, Casting

Time Frame: Start of study to end of study, up to 3 years

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

Genetics Correlations

Time Frame: Start of study to end of study, up to 3 years

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.

Visual Appearance Relationships: Melanoma, Photography

Time Frame: Start of study to end of study, up to 3 years

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

Time Frame: Start of study to end of study, up to 3 years

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: Non-Melanoma , Questionnaire

Time Frame: Start of study to end of study, up to 3 years

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, Casting

Time Frame: Start of study to end of study, up to 3 years

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: Melanoma, Questionnaire

Time Frame: Start of study to end of study, up to 3 years

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: Melanoma, SCINEXA

Time Frame: Start of study to end of study, up to 3 years

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

Secondary Outcomes

  • Primary Melanomas, UV Camera(Start of study to end of study, up to 3 years)
  • Benign Nevi, Mutations(Start of study to end of study, up to 3 years)
  • Primary Melanomas, DNA(Start of study to end of study, up to 3 years)
  • Benign Nevi, DNA(Start of study to end of study, up to 3 years)
  • Benign Nevi, UV Camera(Start of study to end of study, up to 3 years)
  • Self Reporting Behaviors(Start of study to end of study, up to 3 years)
  • Primary Melanomas, Mutations(Start of study to end of study, up to 3 years)
  • Primary Melanomas, Exposure(Start of study to end of study, up to 3 years)
  • Behavioral Intervention and Immediate Follow Up(After wearing dosimetry for 3 weeks)
  • Benign Nevi, Exposure(Start of study to end of study, up to 3 years)

Study Sites (1)

Loading locations...

Similar Trials