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

NCT03783325 | Completed DMC

• 1 other identifier: 16-1603.cc
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nevi and Melanomas

Keywords

Sun Exposure; UV Dosimetry; Biomarkers; Behaviors; Genetics

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (10)

• Self Reporting Behaviors

  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, DNA

  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

• Benign Nevi, Exposure

  Start of study to end of study, up to 3 years

Study Arms (3)

UV Counseling

OTHER

Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma.

Behavioral: UV Counseling

Visual Analysis - UV Photo

EXPERIMENTAL

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

Biological Sample

EXPERIMENTAL

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

Interventions

UV Counseling BEHAVIORAL

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.

UV Counseling

UV Photo OTHER

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.

Visual Analysis - UV Photo

Biological Sample OTHER

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 Sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Nevi and Melanomas; Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Officials

• Neil Box, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 21, 2018
• Study Start: February 17, 2017
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

US (1)