Study of Families With Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Melanoma Family Case-Control Study Protocol

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Newly diagnosed primary invasive melanoma (patient group) Lentigo maligna malignant melanoma allowed Rare variants of melanoma allowed, including any of the following: Acral lentiginous Subungual Ear, nose, and throat Oropharyngeal Perineal Vaginal Vulval Rectal Nodal with no known primary Patients undergoing sentinel node biopsy are eligible No in situ melanoma, melanocytic intraepidermal neoplasia, or ocular melanoma 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: mutation analysis|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: examination|nan|
|Procedure: mutation carrier screening|nan|
|Procedure: study of high risk factors|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lentigo maligna malignant melanoma, stage IV melanoma, acral lentiginous malignant melanoma, nodular malignant melanoma, stage IA melanoma, stage IB melanoma, stage IIA melanoma, stage IIB melanoma, stage IIC melanoma, stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma