Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3700 participants
OBSERVATIONAL
2000-07-31
Brief Summary
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PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma.
Detailed Description
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Primary
* Determine what lifestyle factors and which genes govern relapse from melanoma.
Secondary
* Compare sun exposure and genes that cause melanoma in patients with melanoma vs healthy participants.
* Assess how unusual moles relate to sun exposure and genes that cause melanoma.
OUTLINE: This is a multicenter, cohort study.
Patients and healthy participants complete lifestyle questionnaires by mail and telephone. Some patients\* and healthy participants undergo a skin examination to count moles and classify skin type (e.g., degree of freckling and wrinkling indicative of sun damage).
NOTE: \*Patients diagnosed with primary invasive melanoma after September 2005 do not need to consent to a skin examination.
Patients and healthy participants also undergo blood collection for lymphocyte analysis, DNA extraction, and the measurement of minerals, vitamins, and beta carotene. Tissue samples from original diagnosis are examined by immunohistochemistry for gene expression and mutations, including CDKN2A and CDK4.
Patients and healthy participants are followed annually.
Peer reviewed and funded or endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 3,700 patients and healthy participants will be accrued for this study.
Conditions
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Keywords
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Interventions
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gene expression analysis
mutation analysis
immunohistochemistry staining method
laboratory biomarker analysis
examination
mutation carrier screening
study of high risk factors
Eligibility Criteria
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Inclusion Criteria
* Healthy participant meeting either of the following criteria (control group):
* Relative of a patient who was diagnosed with melanoma after September 2005
* Healthy volunteer who is age- and sex-matched for patients who were diagnosed with melanoma before October 2005
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified
18 Years
ALL
Yes
Sponsors
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Leeds Cancer Centre at St. James's University Hospital
OTHER
Principal Investigators
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Julia Newton Bishop, MD
Role: STUDY_CHAIR
Leeds Cancer Centre at St. James's University Hospital
Locations
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Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Countries
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Facility Contacts
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Contact Person
Role: primary
Other Identifiers
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CDR0000532934
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20704
Identifier Type: -
Identifier Source: secondary_id
CRUK-LCC-1/3/57
Identifier Type: -
Identifier Source: org_study_id