Effects of Simulated Solar Radiation on Human Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Percentage of pixels positive for p53 by immunohistochemical analysis
研究概览
简要总结
This clinical trial examines the effects of simulated solar radiation on human skin in preventing skin cancer. Testing whether new drugs affect biomarkers in the skin is a good first test of whether the drug might prevent skin cancer. Some biomarkers in skin, and even in moles, are affected after a person is exposed to sunlight. This study may help doctors learn more about what happens to the skin and moles when the participants are exposed to the sun.
详细描述
PRIMARY OBJECTIVE:
I. To identify biomarkers of simulated solar radiation (SSR) treatment in human skin that can be used as surrogate endpoints in chemoprevention trials in humans.
SECONDARY OBJECTIVE:
I. Measure Langerhans cell (LC) and sunburn cell density in the epidermis, as well as deoxyribonucleic acid (DNA) damage.
EXPLORATORY OBJECTIVE I. To perform gene expression analysis on tissue frozen after biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-100 years. The investigators anticipate recruiting few if any patients over age 80 as nevi tend to disappear as people age. Both men and women of all races and ethnic groups will be included
- •Participants must have 2 clinically benign melanocytic nevi 3-5 mm in diameter confirmed by clinical dermatoscopic examination by a medically-qualified study team member and suitable for biopsy (i.e. not at a site that would be functionally or cosmetically damaged by the biopsy). The minimum size restriction arises from the need for collection of tissue sufficient for single nucleus ribonucleic acid sequencing (RNAseq) analysis. The maximum size is dictated by the requirement that the entire nevus be removed with a 6 mm punch biopsy, thereby eliminating any concerns that might arise from regrowth of the nevus that can happen after incomplete removal
- •All participants must be able to understand and be willing to sign a written informed consent document
排除标准
- •Undergoing systemic therapy for melanoma or any other cancer
- •Sensitivity to anesthetic agent
- •Photosensitivity
- •Currently taking supplements such as nicotinamide or antioxidants that might protect from skin cancer or alter the response of their skin to simulated solar radiation (SSR)
结局指标
主要结局
Percentage of pixels positive for p53 by immunohistochemical analysis
时间窗: Up to 1 year
Will use immunohistochemical (IHC) analysis of biopsies to determine the difference between the percentage of pixels classified as positive or strong positive for p53 in irradiated nevi (moles) and unirradiated control nevi from each participant. Difference will be measured in percentage points ranging from 0 to 100 with no transformation prior to analysis.
次要结局
- Difference in the number of sunburn cells per high power field in irradiated and unirradiated control nevi(Up to 1 year)
- Percent of the area of the epidermis that is positive for Langerhans cells(Up to 1 year)
- Deoxyribonucleic acid (DNA) damage(Up to 1 year)
研究者
Pamela Cassidy
Principal Investigator
OHSU Knight Cancer Institute