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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00672321
First received: May 3, 2008
Last updated: August 9, 2013
Last verified: July 2009
  Purpose

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 Intervention
Melanoma (Skin)
Genetic: gene expression analysis
Genetic: mutation analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: questionnaire administration

Study Type: Observational
Official Title: Melanoma Lifestyle Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Odds ratio (OR) for vitamin D supplementation in relapse [ Designated as safety issue: No ]
  • OR for vitamin D supplementation in patients with specific VDR genotypes [ Designated as safety issue: No ]

Estimated Enrollment: 2774
Study Start Date: December 2007
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672321

Locations
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
Investigators
Principal Investigator: Julia Newton Bishop, MD Leeds Cancer Centre at St. James's University Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00672321     History of Changes
Other Study ID Numbers: LCC-MREC-07-H1010-66, CDR0000587987
Study First Received: May 3, 2008
Last Updated: August 9, 2013
Health Authority: Unspecified

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

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

ClinicalTrials.gov processed this record on November 23, 2014