Therapeutic effect of the intake high dose Vitamin D on the outcome of malignant melanoma of the ski

Phase 1

Conditions: cutaneous malignant melanoma
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-002125-30-BE

Lead Sponsor: ZLeuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 500

Inclusion Criteria

1.Older than 18 years and younger than 80 years of age.
2.Histologically proven malignant melanoma, stage IB to III Not participating in other clinical trial.
3.The only treatment for melanoma is surgical treatment.
4.Complete resection of melanoma.
5.Single primary invasive cutaneous melanoma (inclusion within 1 year after diagnosis).
6.Signed ethical committee approved informed consent
7.Serum phosphate and calcium at the entry of the study within normal range of the laboratory reference

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1.Pregnant/lactating women or planning on becoming pregnant during the study
2.Known hypersensitivity to vitamin D or its components.
3.Pre-existing renal stone disease or chronic renal disease with eGRF < 30 mL/min/1.73 m2 or renal dialysis.
4.Liver failure or chronic liver disease with liver enzyme > 2 fold ULN (=upper limit of normal)
5.History of parathyroid disease or granulomatous disease (TBC and sarcoidosis)
6.History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption.
7.History of other malignancy within the last 5 years except for carcinoma in situ of the cervix or basal cell carcinoma or squamous cell carcinoma of the skin or in situ malignant melanoma.
8.Chronic alcohol abuse.
9.Medical or logistic problems likely to preclude completion of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether vitamin D supplementation, in the follow up period after diagnosis and surgery of the primary tumor, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with VDR immunoreactivity in the primary tumour. ;Secondary Objective: Furthermore it will be investigated <br>Whether the evolution of 25(OH)D3 serum levels during the study (secondary endpoint) depend on the genetic variability in the vitamin D pathway.<br>Whether VDR immunoreactivity correlates with stage at diagnosis (secondary endpoint)<br>Whether vitamin D levels at diagnosis correlate with stage at diagnosis (secondary endpoint), melanoma site (secondary endpoint) and melanoma subtype (secondary endpoint)<br>Whether genetic variability of Vitamin D pathway correlates with stage at diagnosis (secondary endpoint)<br>;Primary end point(s): Relapse free survival;Timepoint(s) of evaluation of this end point: end of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Melanoma subtype, as assessed clinically and histologically<br>2. Melanoma site, as clinically recorded <br>3. 25(OH)D3 serum levels 4. Stage of melanoma patient at diagnosis according to the 2009 AJCC Melanoma staging and classification<br>;Timepoint(s) of evaluation of this end point: 1. Melanoma subtype, as assessed clinically and histologically: time of diagnosis<br>2. Melanoma site, as clinically recorded: time of diagnosis<br>3. 25(OH)D3 serum levels: time of diagnosis and at 6 months intervals<br>4. Stage of melanoma patient: timor of diagnosis according to the 2009 AJCC Melanoma staging and classification<br>