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| Name | Class |
|---|---|
| Nu Skin Enterprises | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma | baseline | |
| Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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The research population were recruited from Massachusetts General Hospital dermatology clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra B Kimball, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Unit for Research Trials in Skin - MGH | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17943854 | Background | 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. | |
| 2694158 | Background | Santamaria 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. |
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Patients were enrolled in the study if they had a history of cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma but were excluded if they had a history of both basal cell carcinoma and squamous cell carcinoma. Participants were also excluded if they were using retinoids or taking a multivitamin regularly for less than 5 yrs.
Recruitment occurred from May 2009 to December 2011. Subjects were recruited from dermatology medical and surgery clinics at the Massachusetts General Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Previous History of SCC | Participants had previous history of squamous cell carcinoma |
| FG001 | Previous History of BCC | Participants had previous history of basal cell carcinoma |
| FG002 | Control Group | Participants had no history of squamous cell carcinoma or basal cell carcinoma |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Previous History of SCC | Participants had previous history of squamous cell carcinoma |
| BG001 | Previous History of BCC | Participants had previous history of basal cell carcinoma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants that passed inclusion criteria and consented for skin carotenoid measurement were analyzed. | Posted | Mean | Standard Deviation | Raman spectroscopy intensity counts | baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Previous History of SCC | Participants had previous history of squamous cell carcinoma |
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Limitations include a small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Corey | Clinical Unit for Research Trials in Skin, Massachusetts General Hospital | 617-726-1302 | kcorey1@partners.org |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D002280 | Carcinoma, Basal Cell |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 17988857 | Background | Heinen 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. |
| 10677093 | Background | Frieling 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. |
| 18049555 | Background | Ermakov 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. |
| BG002 | Control Group | Participants had no history of squamous cell carcinoma or basal cell carcinoma |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma | Posted | Mean | Standard Deviation | Raman spectroscopy intensity counts | baseline |
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| Secondary | Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group | Posted | Mean | Standard Deviation | Raman spectrocopy intensity counts | baseline |
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| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Previous History of BCC | Participants had previous history of basal cell carcinoma | 0 | 23 | 0 | 23 |
| EG002 | Control Group | Participants had no history of squamous cell carcinoma or basal cell carcinoma | 0 | 36 | 0 | 36 |
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| D002277 |
| Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018295 | Neoplasms, Basal Cell |
| D018307 | Neoplasms, Squamous Cell |