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Completed

NCT Number: NCT03783325

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.

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Key information

Conditions

Nevi and Melanomas Behavior Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

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.

Primary outcomes

  1. 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,

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

Secondary outcomes

  1. Self Reporting Behaviors

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

    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.

  2. Behavioral Intervention and Immediate Follow Up

    Time frame: After wearing dosimetry for 3 weeks

    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.

  3. Benign Nevi, DNA

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

    Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of genomic DNA

  4. Benign Nevi, Mutations

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

    Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of somatic mutations

  5. Benign Nevi, Exposure

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

    Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV exposure history

  6. Benign Nevi, UV Camera

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

    Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV camera scores with the clinical presentation

  7. Primary Melanomas, DNA

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

    Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of genomic DNA

  8. Primary Melanomas, Mutations

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

    Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of somatic mutations

  9. Primary Melanomas, Exposure

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

    Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV exposure history

  10. Primary Melanomas, UV Camera

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

    Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV camera scores with the clinical presentation

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2018
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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