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

August 9, 2013 updated by: Leeds Cancer Centre at St. James's University Hospital

Melanoma Lifestyle Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2774

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Leeds, England, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Cancer Centre at St. James's University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Odds ratio (OR) for vitamin D supplementation in relapse
OR for vitamin D supplementation in patients with specific VDR genotypes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ANTICIPATED)

September 1, 2010

Study Registration Dates

First Submitted

May 3, 2008

First Submitted That Met QC Criteria

May 3, 2008

First Posted (ESTIMATE)

May 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCC-MREC-07-H1010-66
  • CDR0000587987 (REGISTRY: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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