Answering Questions About Vitamin D Supplementation and Sun Exposure in Patients Who Have Undergone Surgery for Stage IB, Stage II, or Stage IIIA Melanoma

• Conditions: Melanoma (Skin)

• Registration Number: NCT00672321
• Lead Sponsor: Leeds Cancer Centre at St. James's University Hospital

Brief Summary

RATIONALE: Gathering information about vitamin D supplementation and sun exposure in patients with melanoma may help doctors learn more about the disease and find what may affect cancer relapse.

PURPOSE: This clinical trial is studying vitamin D supplementation and sun exposure in patients who have undergone surgery for stage IB, stage II, or stage IIIA melanoma.

Detailed Description

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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-05-03
• Study First Submitted QC: 2008-05-03
• Study First Posted: 2008-05-06
• Status Verified: 2009-07
• Primary Completion: 2010-09
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2774

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OR for vitamin D supplementation in patients with specific VDR genotypes
Odds ratio (OR) for vitamin D supplementation in relapse

Trial Locations

Locations (1)

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom