Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- UV Exposure Assessment
研究概览
简要总结
This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 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
排除标准
- •No exclusion criteria listed
研究组 & 干预措施
UV Counseling
Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma.
干预措施: UV Counseling (Behavioral)
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.
干预措施: UV Photo (Other)
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.
干预措施: Biological Sample (Other)
结局指标
主要结局
UV Exposure Assessment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)