Study of Families With Melanoma

Leeds Cancer Centre at St. James's University Hospital3,700 enrolled

Overview

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 * 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.

Study Type

OBSERVATIONAL

Enrollment

3,700

Conditions

Melanoma (Skin)

Interventions

gene expression analysisGENETIC

mutation analysisGENETIC

immunohistochemistry staining methodOTHER

laboratory biomarker analysisOTHER

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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