MelanomaNCT05027009
Effects of Simulated Solar Radiation on Human Skin in Preventing Skin Cancer
A study testing Physical Examination and Solar Simulated Light in people with Melanoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Physical Examination and Solar Simulated Light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2021to 2 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Effects of Simulated Solar Radiation on Human Skin
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Melanoma
- Being tested
- Physical Examination, Solar Simulated Light
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExaminationProcedure or surgery
Also called Assessment, General Examination, Physical, Physical Assessment
Undergo total body exam
Solar Simulated LightOther
Also called Artificial Sunlight, Full-Spectrum Lighting, Solar Simulated Radiation, SSR
Undergo exposures to simulated sunlight
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Physical Examination; Other: Solar Simulated Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start18 Nov 2021
- Primary completion21 Nov 2021
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Pamela Cassidy, OHSU Knight Cancer Institute
- Investigators
- Pamela Cassidy, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027009
- Sponsor's protocol ID
- STUDY00022830
- Other IDs
- NCI-2021-06210, STUDY00022830
- Status last verified
- Jun 2022
- First submitted
- 25 Aug 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Simulated Solar Radiation on Human Skin
- ClinicalTrials.gov ID
- NCT05027009
- Acronym / sponsor ID
- STUDY00022830
- Conditions
- Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 21 Nov 2021 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (low dose simulated sunlight) | Experimental | Procedure: Physical Examination, Other: Solar Simulated LightPatients 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 (middle dose simulated sunlight) | Experimental | Procedure: Physical Examination, Other: Solar Simulated LightPatients 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 (high dose simulated sunlight) | Experimental | Procedure: Physical Examination, Other: Solar Simulated LightPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ExaminationAlso: Assessment, General Examination, Physical, Physical AssessmentUndergo total body exam | Procedure or surgery | Group I (low dose simulated sunlight), Group II (middle dose simulated sunlight), Group III (high dose simulated sunlight) |
| Solar Simulated LightAlso: Artificial Sunlight, Full-Spectrum Lighting, Solar Simulated Radiation, SSRUndergo exposures to simulated sunlight | Other | Group I (low dose simulated sunlight), Group II (middle dose simulated sunlight), Group III (high dose simulated sunlight) |
Primary outcome
Percentage of pixels positive for p53 by immunohistochemical analysis
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.
3 secondary outcomes
Deoxyribonucleic acid (DNA) damage
Time frame: Up to 1 year
Difference in the number of sunburn cells per high power field in irradiated and unirradiated control nevi
Time frame: Up to 1 year
Percent of the area of the epidermis that is positive for Langerhans cells
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Cassidy principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Examination and Solar Simulated Light in people with Melanoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of pixels positive for p53 by immunohistochemical analysis (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.