Trial Information

Melanoma Lifestyle Study

OBJECTIVES:

- To examine the findings of the pilot study, that vitamin D supplementation in
combination with vitamin D receptor (VDR) polymorphisms protects from late relapse
(after 3 years) in patients who have had melanoma.

- To investigate the effects of vitamin D supplement dosage in reducing the risk of late
relapse.

- To examine if vitamin D supplementation in combination with particular VDR
polymorphisms protects from early relapse (before 3 years).

- To examine if serum levels of vitamin D correlate with risk of relapse in groups of
patients with different VDR polymorphisms.

- To examine the effect of vitamin supplementation and VDR status on time to relapse and
survival in these patients.

- To examine other factors that may affect risk of relapse by assembling a tissue
(genomic DNA and serum) resource.

- To investigate the effect of exposure to incidental drugs, such as statins, on risk of
relapse in these patients.

OUTLINE: Patients are stratified according to disease relapse in the past 5 years (yes vs
no).

Patients are asked to complete a food frequency questionnaire focusing on vitamin D and the
following area: supplementation of diet with vitamins/fish oil and duration of use; sun
exposure and sunscreen-use per decade prior to and after diagnosis. Patients are also asked
to provide a blood sample for serum and DNA analysis. Consenting patients are also tagged
with the Office of National Statistics to allow passive follow up.

Stored tissue from the patient's primary melanoma may be used to corroborate research
findings using immunohistochemistry or studies of gene expression, polymorphism, or
mutation.