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

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ClinicalTrials.gov Identifier: NCT00672321
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 6, 2008
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment
Melanoma (Skin) Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: questionnaire administration

Detailed Description:


  • 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 Type : Observational
Estimated Enrollment : 2774 participants
Official Title: Melanoma Lifestyle Study
Study Start Date : December 2007
Estimated Primary Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma Vitamin D
U.S. FDA Resources

Primary Outcome Measures :
  1. Odds ratio (OR) for vitamin D supplementation in relapse
  2. OR for vitamin D supplementation in patients with specific VDR genotypes

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosed with melanoma
  • Must meet either of the following conditions:

    • Resected stage IB, II, or IIIA disease that has relapsed as either stage III or IV disease (cases)

      • First loco regional and/or visceral relapse (with/without sentinel node biopsy)

        • No more than 3 months since first relapse
    • Resected stage IB, II, or IIIA disease that has not relapsed for ≥ 5 years (controls)


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672321

United Kingdom
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Contact Person    44-113-206-6534    p.brunyee@leeds.ac.uk   
Sponsors and Collaborators
Leeds Cancer Centre at St. James's University Hospital
Principal Investigator: Julia Newton Bishop, MD Leeds Cancer Centre at St. James's University Hospital

ClinicalTrials.gov Identifier: NCT00672321     History of Changes
Other Study ID Numbers: LCC-MREC-07-H1010-66
CDR0000587987 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IB melanoma
stage II melanoma
stage IIIA melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas