Study of Families With Melanoma
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|ClinicalTrials.gov Identifier: NCT00445783|
Recruitment Status : Recruiting
First Posted : March 9, 2007
Last Update Posted : August 12, 2013
RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may help doctors understand the risk factors for melanoma relapse.
PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma.
|Condition or disease||Intervention/treatment|
|Melanoma (Skin)||Genetic: gene expression analysis Genetic: mutation analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: examination Procedure: mutation carrier screening Procedure: study of high risk factors|
- Determine what lifestyle factors and which genes govern relapse from melanoma.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||3700 participants|
|Official Title:||Melanoma Family Case-Control Study Protocol|
|Study Start Date :||July 2000|
|Estimated Primary Completion Date :||December 2020|
- Lifestyle factors governing relapse from melanoma
- Genes governing relapse from melanoma
- Sun exposure and genes that cause melanoma
- Unusual moles related to sun exposure and genes that cause melanoma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445783
|Leeds Cancer Centre at St. James's University Hospital||Recruiting|
|Leeds, England, United Kingdom, LS9 7TF|
|Contact: Contact Person 44-113-206-6400|
|Study Chair:||Julia Newton Bishop, MD||Leeds Cancer Centre at St. James's University Hospital|