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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000532934 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20704 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gene expression analysis | Genetic | |||
| mutation analysis | Genetic | |||
| immunohistochemistry staining method | Other | |||
| laboratory biomarker analysis | Other | |||
| examination | Procedure | |||
| mutation carrier screening | Procedure | |||
| study of high risk factors | Procedure |
| 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 |
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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:
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):
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Newton Bishop, MD | Leeds Cancer Centre at St. James's University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Cancer Centre at St. James's University Hospital | Recruiting | Leeds | England | LS9 7TF | United Kingdom |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D020869 | Gene Expression Profiling |
| D007150 | Immunohistochemistry |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D007158 | Immunologic Techniques |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |