Answering Questions About Vitamin D Supplementation and Sun Exposure in Patients Who Have Undergone Surgery for Stage IB, Stage II, or Stage IIIA Melanoma
Primary Purpose
Melanoma (Skin)
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
gene expression analysis
mutation analysis
polymorphism analysis
laboratory biomarker analysis
questionnaire administration
Sponsored by
About this trial
This is an observational trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IB melanoma, stage II melanoma, stage IIIA melanoma
Eligibility 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
Sites / Locations
- Leeds Cancer Centre at St. James's University HospitalRecruiting
Outcomes
Primary Outcome Measures
Odds ratio (OR) for vitamin D supplementation in relapse
OR for vitamin D supplementation in patients with specific VDR genotypes
Secondary Outcome Measures
Full Information
NCT ID
NCT00672321
First Posted
May 3, 2008
Last Updated
August 9, 2013
Sponsor
Leeds Cancer Centre at St. James's University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00672321
Brief Title
Answering Questions About Vitamin D Supplementation and Sun Exposure in Patients Who Have Undergone Surgery for Stage IB, Stage II, or Stage IIIA Melanoma
Official Title
Melanoma Lifestyle Study
Study Type
Observational
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Leeds Cancer Centre at St. James's University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage IB melanoma, stage II melanoma, stage IIIA melanoma
7. Study Design
Enrollment
2774 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Odds ratio (OR) for vitamin D supplementation in relapse
Title
OR for vitamin D supplementation in patients with specific VDR genotypes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Newton Bishop, MD
Organizational Affiliation
Leeds Cancer Centre at St. James's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-113-206-6534
Email
p.brunyee@leeds.ac.uk
12. IPD Sharing Statement
Learn more about this trial
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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