Non-melanomatous Skin CancerNCT00099112
Effect of Solar-Simulated Ultraviolet Radiation on Gene Expression in Unprotected and Sunscreen-Protected Skin of Healthy Adults With Fitzpatrick Skin Type II
An observational study of Non-melanomatous Skin Cancer and Precancerous Condition, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
RATIONALE: Testing of skin that has been exposed to artificial sunlight may help in understanding the genetic processes involved in the development of skin cancer. PURPOSE: This trial is studying the effect of solar-simulated ultraviolet radiation on skin with or without sunscreen in healthy adults with skin that… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-melanomatous Skin Cancer, Precancerous Condition
- What is being tested?
- microarray analysis, biopsy and evaluation of cancer risk factors
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to not given
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
DISEASE CHARACTERISTICS:
- Healthy, fair-skinned adults
- Fitzpatrick skin type II by history and physical exam
- Skin easily burns, and tans only slightly, after sun exposure
- Test site for solar-simulated ultraviolet radiation exposure (buttocks) devoid of sunburn, suntan, scars, active dermal lesions, and uneven skin tones
- Nevi allowed at physician discretion
- Excess hair must be clipped or shaved
- No prior nonmelanoma skin cancer, melanoma, or dysplastic nevi
PATIENT CHARACTERISTICS:
Age
- 18 to 45
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No prior malignancy
- No prior phototoxic, photoallergic, or other abnormal responses to sunlight
- No prior allergic reaction to sunscreen or lidocaine
- No underlying disease that is known to cause immunosuppression (e.g., HIV, cancer, or post-organ transplantation)
- No situation that would preclude study compliance
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 6 months since prior topical or systemic medication producing abnormal sunlight responses
- No concurrent medications with > 1% incidence of sun-related toxic effects
- No concurrent medications associated with abnormal light response
- No concurrent immunosuppressants
- No other concurrent ultraviolet radiation (e.g., sunlight or tanning bed) to the epidermal test site
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: Transcriptional Profiling of the Epidermal Response to Solar-Simulated Ultraviolet Radiation
RATIONALE: Testing of skin that has been exposed to artificial sunlight may help in understanding the genetic processes involved in the development of skin cancer.
PURPOSE: This trial is studying the effect of solar-simulated ultraviolet radiation on skin with or without sunscreen in healthy adults with skin that burns easily after only slight tanning during sun exposure.
Read the detailed description
OBJECTIVES:
- Determine the global gene expression profiles in epidermal tissue of healthy fair-skinned adults with Fitzpatrick skin type II after exposure to known doses of solar-simulated ultraviolet radiation (ssUVR) (UVA).
- Determine the ability of an FDA-standardized sunscreen to alter ssUVR-induced transcription profiles in vivo in these participants.
- Determine whether the transcriptional profiles of keratinocytes exposed to UVR in cell culture are comparable to the profiles of keratinocytes in skin after similar levels of UVR exposure.
OUTLINE: This is a pilot, dose-response study followed by an in vivo transcriptional profiling study in 2 different groups.
- Pilot study (verification of ultraviolet radiation dose response): Participants are initially exposed to solar-simulated ultraviolet radiation (ssUVR) (UVA) on the back to determine the minimum erythema dose (MED). Between 22-24 hours after exposure, participants undergo shave biopsy from each of the 9 UV exposure sites and 1 unexposed skin site.
- Group 1 (determination of ssUVR and UVA in vivo transcriptional profiles): On day 1, participants are initially exposed to ssUVR on the back to determine the MED. On day 2, participants are exposed to ssUVR (3 sites) and UVA (3 sites) at the MED on the buttocks. Between 22-24 hours after exposure (day 3), participants undergo shave biopsy from each of the 6 UV exposure sites and 2 unexposed skin sites.
- Group 2 (determination of sunscreen-protected in vivo transcriptional profiles): On day 1, participants are initially exposed to ssUVR on the back to determine the MED. On day 2, participants are exposed to ssUVR on unprotected skin (3 sites) and sunscreen-protected skin (3 sites) at the MED on the buttocks. Between 22-24 hours after exposure (day 3), participants undergo shave biopsy from each of the 6 UV exposure sites and 2 unexposed skin sites.
Biopsies from all participants are analyzed by microarray analysis. One of the unexposed epidermal samples is used for primary keratinocyte culture.
PROJECTED ACCRUAL: A total of 6-56 participants (6 for the pilot study and 50 [25 per group] for transcriptional profiling) will be accrued for this study within 2 months.
- Being tested
- microarray analysis, biopsy, evaluation of cancer risk factors
- Keywords
- basal cell carcinoma of the skin, squamous cell carcinoma of the skin, actinic keratosis
- Medical subject headings
- Precancerous Conditions, Carcinoma, Basal Cell, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microarray analysisGenetic
biopsyProcedure or surgery
evaluation of cancer risk factorsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2004 (estimated)
- Study startFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanomatous Skin CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Observational
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jonathan C. Vogel, MD, Study chair, NCI - Dermatology Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099112
- Sponsor's protocol ID
- CDR0000357437
- Other IDs
- NCI-04-C-0120
- Status last verified
- Nov 2005
- First submitted
- 8 Dec 2004
- Last updated
- 30 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptional Profiling of the Epidermal Response to Solar-Simulated Ultraviolet Radiation
- ClinicalTrials.gov ID
- NCT00099112
- Acronym / sponsor ID
- CDR0000357437
- Keywords
- basal cell carcinoma of the skin, squamous cell carcinoma of the skin, actinic keratosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 2004
- First posted
- 9 Dec 2004 (estimated)
- 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.
RATIONALE: Testing of skin that has been exposed to artificial sunlight may help in understanding the genetic processes involved in the development of skin cancer.
PURPOSE: This trial is studying the effect of solar-simulated ultraviolet radiation on skin with or without sunscreen in healthy adults with skin that burns easily after only slight tanning during sun exposure.
Detailed description
OBJECTIVES:
- Determine the global gene expression profiles in epidermal tissue of healthy fair-skinned adults with Fitzpatrick skin type II after exposure to known doses of solar-simulated ultraviolet radiation (ssUVR) (UVA).
- Determine the ability of an FDA-standardized sunscreen to alter ssUVR-induced transcription profiles in vivo in these participants.
- Determine whether the transcriptional profiles of keratinocytes exposed to UVR in cell culture are comparable to the profiles of keratinocytes in skin after similar levels of UVR exposure.
OUTLINE: This is a pilot, dose-response study followed by an in vivo transcriptional profiling study in 2 different groups.
- Pilot study (verification of ultraviolet radiation dose response): Participants are initially exposed to solar-simulated ultraviolet radiation (ssUVR) (UVA) on the back to determine the minimum erythema dose (MED). Between 22-24 hours after exposure, participants undergo shave biopsy from each of the 9 UV exposure sites and 1 unexposed skin site.
- Group 1 (determination of ssUVR and UVA in vivo transcriptional profiles): On day 1, participants are initially exposed to ssUVR on the back to determine the MED. On day 2, participants are exposed to ssUVR (3 sites) and UVA (3 sites) at the MED on the buttocks. Between 22-24 hours after exposure (day 3), participants undergo shave biopsy from each of the 6 UV exposure sites and 2 unexposed skin sites.
- Group 2 (determination of sunscreen-protected in vivo transcriptional profiles): On day 1, participants are initially exposed to ssUVR on the back to determine the MED. On day 2, participants are exposed to ssUVR on unprotected skin (3 sites) and sunscreen-protected skin (3 sites) at the MED on the buttocks. Between 22-24 hours after exposure (day 3), participants undergo shave biopsy from each of the 6 UV exposure sites and 2 unexposed skin sites.
Biopsies from all participants are analyzed by microarray analysis. One of the unexposed epidermal samples is used for primary keratinocyte culture.
PROJECTED ACCRUAL: A total of 6-56 participants (6 for the pilot study and 50 [25 per group] for transcriptional profiling) will be accrued for this study within 2 months.
Study design
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| microarray analysis | Genetic | – |
| biopsy | Procedure or surgery | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 30 Apr 2015.
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.
Jonathan C. Vogel, MD study chair
NCI - Dermatology Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-melanomatous Skin Cancer and Precancerous Condition, run by National Cancer Institute (NCI) 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?
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 30 Apr 2015. 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.
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 30 Apr 2015.