Trial Information

Melanoma Family Case-Control Study Protocol

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.