Melanoma (Skin)NCT00672321
Answering Questions About Vitamin D Supplementation and Sun Exposure in Patients Who Have Undergone Surgery for Stage IB, Stage II, or Stage IIIA Melanoma
An observational study of Melanoma (Skin), run by Leeds Cancer Centre at St. James's University Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- gene expression analysis, mutation analysis and polymorphism analysis
- How many people
- 2,774 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2007to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Contact Person, 44-113-206-6534, p.brunyee@leeds.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Melanoma (Skin)
- Being tested
- gene expression analysis, mutation analysis, polymorphism analysis, laboratory biomarker analysis, questionnaire administration
- Keywords
- recurrent melanoma, stage IB melanoma, stage II melanoma, stage IIIA melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
mutation analysisGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
questionnaire administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds ratio (OR) for vitamin D supplementation in relapse
OR for vitamin D supplementation in patients with specific VDR genotypes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 2,774 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeds Cancer Centre at St. James's University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Julia Newton Bishop, MD, Principal investigator, Leeds Cancer Centre at St. James's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672321
- Sponsor's protocol ID
- LCC-MREC-07-H1010-66
- Other IDs
- CDR0000587987
- Status last verified
- Jul 2009
- First submitted
- 3 May 2008
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanoma Lifestyle Study
- ClinicalTrials.gov ID
- NCT00672321
- Acronym / sponsor ID
- LCC-MREC-07-H1010-66
- Conditions
- Melanoma (Skin)
- Keywords
- recurrent melanoma, stage IB melanoma, stage II melanoma, stage IIIA melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,774 participants (estimated)
- Lead sponsor
- Leeds Cancer Centre at St. James's University HospitalUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Sep 2010 (estimated)
- First posted
- 6 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysis | Genetic | – |
| mutation analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| questionnaire administration | Other | – |
Primary outcome
Odds ratio (OR) for vitamin D supplementation in relapse
OR for vitamin D supplementation in patients with specific VDR genotypes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leeds Cancer Centre at St. James's University Hospital
Leeds, United Kingdom
Julia Newton Bishop, MD principal investigator
Leeds Cancer Centre at St. James's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma (Skin), run by Leeds Cancer Centre at St. James's University Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odds ratio (OR) for vitamin D supplementation in relapse. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.