An interventional study of Physical Examination and Solar Simulated Light in Melanoma, sponsored by OHSU Knight Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-06-09.
Sponsored by OHSU Knight Cancer Institute · Not applicable, Interventional, and Basic science
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.
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 6 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
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Exclusion Criteria:
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.
Procedure: Physical Examination · Other: Solar Simulated Light
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.
Procedure: Physical Examination · Other: Solar Simulated Light
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.
Procedure: Physical Examination · Other: Solar Simulated Light
Undergo total body exam
Also known as: Assessment, General Examination, Physical, Physical Assessment, Physical Exam, physical_exam
Undergo exposures to simulated sunlight
Also known as: Artificial Sunlight, Full-Spectrum Lighting, Solar Simulated Radiation, SSR
Percentage of pixels positive for p53 by immunohistochemical analysis
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
Deoxyribonucleic acid (DNA) damage
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
Difference in the number of sunburn cells per high power field in irradiated and unirradiated control nevi
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
Percent of the area of the epidermis that is positive for Langerhans cells
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.
Time frame: Up to 1 year
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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OHSU Knight Cancer Institute