NCT00445783

Study of Families With Melanoma

Melanoma Family Case-Control Study Protocol

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,700 (estimated)
• Sponsor: Leeds Cancer Centre at St. James's University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2000-07-01
• Primary completion: 2020-12-01
• First posted: 2007-03-09
• Last updated: 2013-08-12

Locations

1 site across 1 country: United Kingdom