Clinical Trial: Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Brief Summary: To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.

Detailed Summary: To assess whether vitamin D supplementation, in the follow up period after diagnosis and surgery of a first cutaneous malignant melanoma, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and vitamin D receptor (VDR) immunoreactivity in the primary tumor.
Sponsor: Universitaire Ziekenhuizen Leuven

Current Primary Outcome: Relapse free survival [ Time Frame: study duration maximum 3,5 years ]

Disease free survival will be the primary endpoint of this phase III trial. Patients are enrolled during a recruitment phase of three years maximum. Study duration for one patient is maximum 3,5 years or until relapse occurs.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Melanoma subtype, as assessed clinically and histologically [ Time Frame: study duration maximum 3,5 years ]
    Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically.
  • Melanoma site, as clinically recorded [ Time Frame: study duration maximum 3,5 years ]
    Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded.
  • 25(OH)D3 serum levels [ Time Frame: study duration maximum 3,5 years ]
    25(OH)D3 serum levels will be recorded at diagnosis and at 6 months intervals up to final study visit. Genetic variability of Vitamin D pathway will be correlated with 25(OH)D3 serum levels
  • Stage of melanoma patient [ Time Frame: study duration maximum 3,5 years ]
    Vitamin D levels at diagnosis and genetic variability of the vitamin D pathway will be correlated with stage of melanoma patient at diagnosis according to the 2009 American Joint Committee of Cancer (AJCC) Melanoma staging and classification


Original Secondary Outcome: Same as current

Information By: Universitaire Ziekenhuizen Leuven

Dates:
Date Received: December 5, 2012
Date Started: December 2012
Date Completion: December 2017
Last Updated: May 15, 2017
Last Verified: October 2016