Skin CancerNCT00836342
Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer
An observational study of Skin Cancer and Basal Cell Carcinoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine the difference of skin carotenoid levels between subjects with previous squamous cell carcinomas (SCC), subjects with previous basal cell carcinomas (BCC) and a control group. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The research population were recruited from Massachusetts General Hospital dermatology clinics.
Who may be able to join
- Subjects between 50 and 75 years old without history of previous SCC or BCC.
- Fitzpatrick skin types I-IV.
- Willing and able to understand and sign informed consent.
- Able to complete study and comply with study procedures
Who cannot join
- Regular ingestion of supplements containing carotenoids or vitamin A in the past 4 weeks.
- Use of topical retinoids in the past 4 weeks.
- Treatment with systemic retinoids in the past 6 months.
- Dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, palmar psoriasis, hand dermatitis or palmo-plantar keratoderma.
- Previous history of psoriasis.
- Clinically significant abnormal findings or conditions, which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
- Subjects who are known to be pregnant or planning a pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Unit for Research Trials in Skin - MGH
Boston, Massachusetts, 02114
About this study
Official title: Comparison of Skin Carotenoid Levels Between Subjects With History of Cutaneous Squamous Cell Carcinoma and Subjects With History of Basal Cell Carcinoma Versus a Control Group
The purpose of this study is to determine the difference of skin carotenoid levels between subjects with previous squamous cell carcinomas (SCC), subjects with previous basal cell carcinomas (BCC) and a control group.
Read the detailed description
There has been experimental and clinical research evaluating association of different carotenoids and incidence of malignancies, including Non- Melanoma Skin Cancer (NMSC). An easy and inexpensive way to determine which subjects would benefit from supplementation with carotenoids or retinoids could be the measurement of skin carotenoid levels.The least invasive way to perform it is through Raman spectroscopy which is a technique that uses a laser light that can be used to quantify carotenoids on the skin. We will compare the skin carotenoid levels of subjects with previous history of SCC or BCC and subjects without history of previous NMSC.
- Conditions
- Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
- Keywords
- Non-melanoma skin cancer, Basal cell carcinoma, Squamous cell carcinoma
- Medical subject headings
- Skin Neoplasms, Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Previous history of SCC | Participants had previous history of SCC | |
| Previous history of BCC | Participants had previous history of BCC | |
| Control | Participants had no previous history of squamous cell carcinoma or basal cell carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects
Mean carotenoid levels in subjects with a history of squamous cell carcinoma were compared to mean carotenoid levels in control subjects without a history of nonmelanoma skin cancer.
Measured: baseline
Secondary outcomes (2)
Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma
Measured: baseline
Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nu Skin Enterprises
- Responsible party
- Principal investigator, Alexandra Kimball, Massachusetts General Hospital
- Investigators
- Alexandra B Kimball, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836342
- Sponsor's protocol ID
- 2008-P-002240
- Status last verified
- Jun 2012
- First submitted
- 2 Feb 2009
- Last updated
- 25 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bath-Hextall F, Leonardi-Bee J, Somchand N, Webster A, Delitt J, Perkins W. Interventions for preventing non-melanoma skin cancers in high-risk groups. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD005414. doi: 10.1002/14651858.CD005414.pub2.
PubMed 17943854Santamaria L, Bianchi A. Cancer chemoprevention by supplemental carotenoids in animals and humans. Prev Med. 1989 Sep;18(5):603-23. doi: 10.1016/0091-7435(89)90033-9.
PubMed 2694158Heinen MM, Hughes MC, Ibiebele TI, Marks GC, Green AC, van der Pols JC. Intake of antioxidant nutrients and the risk of skin cancer. Eur J Cancer. 2007 Dec;43(18):2707-16. doi: 10.1016/j.ejca.2007.09.005. Epub 2007 Nov 7.
PubMed 17988857Frieling UM, Schaumberg DA, Kupper TS, Muntwyler J, Hennekens CH. A randomized, 12-year primary-prevention trial of beta carotene supplementation for nonmelanoma skin cancer in the physician's health study. Arch Dermatol. 2000 Feb;136(2):179-84. doi: 10.1001/archderm.136.2.179.
PubMed 10677093Ermakov IV, Ermakova MR, McClane RW, Gellermann W. Resonance Raman detection of carotenoid antioxidants in living human tissues. Opt Lett. 2001 Aug 1;26(15):1179-81. doi: 10.1364/ol.26.001179.
PubMed 18049555
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Skin Carotenoid Levels Between Subjects With History of Cutaneous Squamous Cell Carcinoma and Subjects With History of Basal Cell Carcinoma Versus a Control Group
- ClinicalTrials.gov ID
- NCT00836342
- Acronym / sponsor ID
- 2008-P-002240
- Conditions
- Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
- Keywords
- Non-melanoma skin cancer, Basal cell carcinoma, Squamous cell carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Nu Skin Enterprises
- Study start
- Feb 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 25 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the difference of skin carotenoid levels between subjects with previous squamous cell carcinomas (SCC), subjects with previous basal cell carcinomas (BCC) and a control group.
Detailed description
There has been experimental and clinical research evaluating association of different carotenoids and incidence of malignancies, including Non- Melanoma Skin Cancer (NMSC). An easy and inexpensive way to determine which subjects would benefit from supplementation with carotenoids or retinoids could be the measurement of skin carotenoid levels.The least invasive way to perform it is through Raman spectroscopy which is a technique that uses a laser light that can be used to quantify carotenoids on the skin. We will compare the skin carotenoid levels of subjects with previous history of SCC or BCC and subjects without history of previous NMSC.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Previous history of SCC | – | –Participants had previous history of SCC |
| Previous history of BCC | – | –Participants had previous history of BCC |
| Control | – | –Participants had no previous history of squamous cell carcinoma or basal cell carcinoma |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The research population were recruited from Massachusetts General Hospital dermatology clinics.
Key inclusion criteria (4 listed)
- Subjects between 50 and 75 years old without history of previous SCC or BCC.
- Fitzpatrick skin types I-IV.
- Willing and able to understand and sign informed consent.
- Able to complete study and comply with study procedures
Key exclusion criteria (7 listed)
- Regular ingestion of supplements containing carotenoids or vitamin A in the past 4 weeks.
- Use of topical retinoids in the past 4 weeks.
- Treatment with systemic retinoids in the past 6 months.
- Dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, palmar psoriasis, hand dermatitis or palmo-plantar keratoderma.
- Previous history of psoriasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects
Time frame: baseline
Mean carotenoid levels in subjects with a history of squamous cell carcinoma were compared to mean carotenoid levels in control subjects without a history of nonmelanoma skin cancer.
2 secondary outcomes
Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma
Time frame: baseline
Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17943854Bath-Hextall F, Leonardi-Bee J, Somchand N, Webster A, Delitt J, Perkins W. Interventions for preventing non-melanoma skin cancers in high-risk groups. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD005414. doi: 10.1002/14651858.CD005414.pub2.
- Background: PubMed 2694158Santamaria L, Bianchi A. Cancer chemoprevention by supplemental carotenoids in animals and humans. Prev Med. 1989 Sep;18(5):603-23. doi: 10.1016/0091-7435(89)90033-9.
- Background: PubMed 17988857Heinen MM, Hughes MC, Ibiebele TI, Marks GC, Green AC, van der Pols JC. Intake of antioxidant nutrients and the risk of skin cancer. Eur J Cancer. 2007 Dec;43(18):2707-16. doi: 10.1016/j.ejca.2007.09.005. Epub 2007 Nov 7.
- Background: PubMed 10677093Frieling UM, Schaumberg DA, Kupper TS, Muntwyler J, Hennekens CH. A randomized, 12-year primary-prevention trial of beta carotene supplementation for nonmelanoma skin cancer in the physician's health study. Arch Dermatol. 2000 Feb;136(2):179-84. doi: 10.1001/archderm.136.2.179.
- Background: PubMed 18049555Ermakov IV, Ermakova MR, McClane RW, Gellermann W. Resonance Raman detection of carotenoid antioxidants in living human tissues. Opt Lett. 2001 Aug 1;26(15):1179-81. doi: 10.1364/ol.26.001179.
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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.
Alexandra B Kimball, MD, MPH principal investigator
Massachusetts General Hospital
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 Skin Cancer and Basal Cell Carcinoma, run by Massachusetts General Hospital 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 4 inclusion and 7 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 25 Jul 2012. 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?
Yes. Results are posted in the registry (first posted 25 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00836342, which also lists 5 linked publications.
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 25 Jul 2012.