Study of Families With Melanoma

Leeds Cancer Centre at St. James's University Hospital

Status: Unknown

Conditions: Melanoma (Skin)

Treatments: Procedure: mutation carrier screening; Procedure: study of high risk factors; Genetic: mutation analysis; Procedure: examination; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Genetic: gene expression analysis

Study type: Observational

Funder types: Other

Identifiers

NCT00445783

CRUK-LCC-1/3/57

CDR0000532934 (Registry Identifier)

EU-20704

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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