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临床试验/NCT00672321
NCT00672321Unknown不适用

Melanoma Lifestyle Study

Leeds Cancer Centre at St. James's University Hospital1 个研究点 分布在 1 个国家目标入组 2,774 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,774
试验地点
1
主要终点
Odds ratio (OR) for vitamin D supplementation in relapse

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Odds ratio (OR) for vitamin D supplementation in relapse

OR for vitamin D supplementation in patients with specific VDR genotypes

次要结局

未报告次要终点

研究者

发起方
Leeds Cancer Centre at St. James's University Hospital
申办方类型
Other

研究点 (1)

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