NCT00672321

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,774

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Last Updated

August 12, 2013

Status Verified

July 1, 2009

Enrollment Period

2.8 years

First QC Date

May 3, 2008

Last Update Submit

August 9, 2013

Conditions

Melanoma (Skin)

Keywords

recurrent melanomastage IB melanomastage II melanomastage IIIA melanoma

Outcome Measures

Primary Outcomes (2)

  • Odds ratio (OR) for vitamin D supplementation in relapse

  • OR for vitamin D supplementation in patients with specific VDR genotypes

Interventions

gene expression analysisGENETIC
mutation analysisGENETIC
polymorphism analysisGENETIC
laboratory biomarker analysisOTHER
questionnaire administrationOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Gene Expression ProfilingAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesDNA FingerprintingPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Julia Newton Bishop, MD

    Leeds Cancer Centre at St. James's University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2008

First Posted

May 6, 2008

Study Start

December 1, 2007

Primary Completion

September 1, 2010

Last Updated

August 12, 2013

Record last verified: 2009-07

Locations

GB(1)