NCT00836342

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 25, 2012

Completed
Last Updated

July 25, 2012

Status Verified

June 1, 2012

Enrollment Period

2.9 years

First QC Date

February 2, 2009

Results QC Date

May 14, 2012

Last Update Submit

June 24, 2012

Conditions

Keywords

Non-melanoma skin cancerBasal cell carcinomaSquamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

Study Arms (3)

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

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The research population were recruited from Massachusetts General Hospital dermatology clinics.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Unit for Research Trials in Skin - MGH

Boston, Massachusetts, 02114, United States

Location

Related Publications (5)

  • 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.

    PMID: 17943854BACKGROUND
  • 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.

    PMID: 2694158BACKGROUND
  • 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.

    PMID: 17988857BACKGROUND
  • 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.

    PMID: 10677093BACKGROUND
  • 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.

    PMID: 18049555BACKGROUND

MeSH Terms

Conditions

Skin NeoplasmsCarcinoma, Basal CellCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Basal CellNeoplasms, Squamous Cell

Limitations and Caveats

Limitations include a small sample size

Results Point of Contact

Title
Kristen Corey
Organization
Clinical Unit for Research Trials in Skin, Massachusetts General Hospital

Study Officials

  • Alexandra B Kimball, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Unit for Research Trials in Skin

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 4, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

July 25, 2012

Results First Posted

July 25, 2012

Record last verified: 2012-06

Locations