Study of Families With Melanoma

Melanoma Family Case-Control Study Protocol

Sponsors

Lead Sponsor: Leeds Cancer Centre at St. James's University Hospital

Source National Cancer Institute (NCI)
Brief Summary

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

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.

Overall Status Unknown status
Start Date 2000-07-01
Primary Completion Date 2020-12-01
Study Type Observational
Primary Outcome
Measure 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
Enrollment 3700
Condition
Intervention

Intervention Type: Genetic

Intervention Name: gene expression analysis

Intervention Type: Genetic

Intervention Name: mutation analysis

Intervention Type: Other

Intervention Name: immunohistochemistry staining method

Intervention Type: Other

Intervention Name: laboratory biomarker analysis

Intervention Type: Procedure

Intervention Name: examination

Intervention Type: Procedure

Intervention Name: mutation carrier screening

Intervention Type: Procedure

Intervention Name: study of high risk factors

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Julia Newton Bishop, MD Study Chair Leeds Cancer Centre at St. James's University Hospital
Location
Facility: Status: Contact: Leeds Cancer Centre at St. James's University Hospital Contact Person 44-113-206-6400
Location Countries

United Kingdom

Verification Date

2008-04-01

Keywords
Has Expanded Access No
Condition Browse

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