Effects of Simulated Solar Radiation on Human Skin in Preventing Skin Cancer

NCT05027009 | Completed

• 2 other identifiers: STUDY00022830NCI-2021-06210
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 year

Secondary Outcomes (3)

• Deoxyribonucleic acid (DNA) damage

  Up to 1 year

• 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

Study Arms (3)

Group I (low dose simulated sunlight)

EXPERIMENTAL

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

Group II (middle dose simulated sunlight)

EXPERIMENTAL

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

Group III (high dose simulated sunlight)

EXPERIMENTAL

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

Interventions

Physical Examination PROCEDURE

Undergo total body exam

Also known as: Assessment, General Examination, Physical, Physical Assessment, Physical Exam, physical_exam

Group I (low dose simulated sunlight); Group II (middle dose simulated sunlight); Group III (high dose simulated sunlight)

Solar Simulated Light OTHER

Undergo exposures to simulated sunlight

Also known as: Artificial Sunlight, Full-Spectrum Lighting, Solar Simulated Radiation, SSR

Group I (low dose simulated sunlight); Group II (middle dose simulated sunlight); Group III (high dose simulated sunlight)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Pamela Cassidy

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 30, 2021
• Study Start: November 18, 2021
• Primary Completion: November 21, 2021
• Study Completion: June 2, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

US (1)