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 ]
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