OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
NCT Number: NCT05027009
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.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Portland, Oregon, 97239, United States
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.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 3 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy.
GROUP II: Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 4 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy.
GROUP III: Patients undergo total body exam. The minimum dose of simulated sunlight required to cause mild sunburn is determined. One of the patient's moles is exposed to 6 times that minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are removed by punch biopsy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo total body exam
Other names: Assessment, General Examination, Physical, Physical Assessment, Physical Exam, physical_exam
Undergo exposures to simulated sunlight
Other names: Artificial Sunlight, Full-Spectrum Lighting, Solar Simulated Radiation, SSR
Time frame: 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.
Time frame: Up to 1 year
Will use IHC analysis of biopsies to examine the difference between the percentage of nuclei in 3 high-powered fields classified as positive or strong positive for cyclobutane pyrimidine dimers (CPDs) or 8-oxoguanine in irradiated nevi and unirradiated control nevi from each participant. Differences will be measured in percentage points ranging from 0 to 100 with no transformation prior to analysis.
Time frame: Up to 1 year
Will use immunohistochemical analysis of biopsies to examine the difference between the number of apoptotic keratinocytes (sunburn cells) in irradiated nevi and unirradiated control nevi from each participant. Differences will be measured in percentage points ranging from 0 to 100 with no transformation prior to analysis.
Time frame: Up to 1 year
Will use immunohistochemical analysis of biopsies to examine the difference between the area of the epidermis positive for Cd1a in irradiated and unirradiated control nevi. Differences will be measured in percentage points ranging from 0 to 100 with no transformation prior to analysis.
OHSU Knight Cancer Institute
Other
Effects of Simulated Solar Radiation on Human Skin
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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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