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Trial registered on ANZCTR
Registration number
ACTRN12609000351213
Ethics application status
Approved
Date submitted
4/05/2009
Date registered
25/05/2009
Date last updated
22/12/2021
Date data sharing statement initially provided
9/07/2019
Date results provided
22/12/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Vitamin D following primary treatment of melanoma at high risk of recurrence
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Scientific title
Assessing the feasibility, safety and toxicity of vitamin D following primary treatment of melanoma at high risk of recurrence: A pilot placebo controlled randomised phase II trial
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Secondary ID [1]
884
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02.09 Mel-D
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Universal Trial Number (UTN)
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Trial acronym
Mel-D
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cutaneous malignant melanoma
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Condition category
Condition code
Cancer
5034
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0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Oral vitamin D3 tablets (Calciferol D Forte 1.25mg) 50 000IU or matching placebo administered during first study visit post-randomisation (10 tablets administered in total). Thereafter, self-adminstration of one vitamin D3 tablet (Calciferol D Forte) 50 000IU by patients on first day of every month for 23 months.
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Intervention code [1]
4479
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Treatment: Drugs
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Comparator / control treatment
Placebo (Sugar pill)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Dose sufficiency : At 12 and 24 months, most treated patients achieve a serum 25 hydroxy vitamin D (25OH D) of 80nmol/l and the average serum 25 hydroxy vitamin D (25OH D) for treated patients is >75nmol/l.
Assays and diagnostic tests will be performed at timepoints to measure serum 25 hydroxy vitamin D (25OH D) level.
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Assessment method [1]
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Timepoint [1]
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At baseline, 4, 12 and 24 months post-randomisation
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Primary outcome [2]
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Dose compliance: On average, patients take >80% of prescribed monthly dose.
The study team willl confirm compliance to treatment by contacting study patients at interim periods during the treatment phase and also during 4 monthly follow-up visits. Additionally, patients will be asked to keep a diary to record their use of the study drug. These diaries will be reviewed on a 4 monthly basis at follow-up visits.
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Assessment method [2]
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Timepoint [2]
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Baseline visit plus every 4 months for 2 years
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Primary outcome [3]
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Safety:
i) Calcium - Over the course of the study, the mean serum calcium concentration in each patient is <2.75mmol/l (11mg/dl).
There is no increase in the prevalence of hypercalcaemia relative to the baseline prevalence.
Over the course of the study, the mean urinary calcium to creatinine ratio in each patient is <1.0 (when calcium and creatinine are measured in nmol).
There is no increase in the prevalence of hypercalciuria relative to the baseline prevalence.
ii) Renal - Over the course of the study, the decrease in average estimated Glomerular Filtration Rate (eGFR) is no more than 20%.
At the end of the study, the average estimated Glomerular Filtration Rate (eGFR) is no more than 20% less in vitamin D treated patients than in placebo treated patients.
iii) Renal calculi - During the course of the study, no more than two episodes of renal calculus occuring in vitamin D treated patients.
Assays and diagnostic tests would be performed to measure (i)-(iii). These include:
- Renal and liver function tests (including estimated Glomerular Filtration Rate (eGFR) and urine calcium/creatinine ratio)
- Serum 25 hydroxy vitamin D (25OH D) levels
- Serum corrected calcium levels
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Assessment method [3]
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Timepoint [3]
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i) Calcium - Baseline visit plus every 4 months for 2 years
ii) Renal - Baseline visit plus every second study visit (i.e. at 8, 16 and 24 months)
iii) Renal Calculi - Baseline visit plus every 4 months for 2 years
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Secondary outcome [1]
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Participation rate: 60% of patients who are both eligible and invited agree to participate.
Participation rate will be monitored and reported as the proportion of subjects eligible and invited agree to participate.
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Assessment method [1]
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Timepoint [1]
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At the end of the study
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Secondary outcome [2]
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Progression free survival.
Monitoring for recurrence will continue as per standard practice of the monitoring institute and also during the 4 monthly follow-up visits.
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Assessment method [2]
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Timepoint [2]
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Baseline visit plus every 4 months for 2 years
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Eligibility
Key inclusion criteria
i) Primary, histologically confirmed resected stage IIb, IIc, IIIa (N1a) and IIIb (N1a, N2a) cutaneous melanoma
ii) Wide excision or if there is no wide excision, excision of the primary lesion with clear pathological marigins <90 days prior to randomisation
iii) Serum corrected calcium and urinary calcium to creatinine ratio within normal range for testing laboratory
iv) Serum creatinine <=1.5 times the institutional upper limit of normal and estimated Glomerular Filtration Rate (eGFR) within normal range for testing laboratory.
v) Serum Low-density Lipoprotein <1.5 upper limit of normal (ULN)
vi) Able to provide written informed consent
vii) Geographically accessible and willing and able to attend 4 monthly folllow-up visits at Sydney Melanoma Unit (SMU) for 2 years
viii) Performance status - Eastern Cooperative Oncology Group (ECOG) score between 0 and 2
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Minimum age
18
Years
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Maximum age
79
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
i) Patients with a known history of renal calculi
ii) Patients with a known history of hyperthyroidism
iii) Patients who have a concomitant invasive cancer other than basal cell carcinoma of the skin or localised squamous cell carcinoma of the skin or a previous such cancer and have been cancer free for less than 5 years
iv) Any of the following laboratory results (tests must not have been carried out more than 4 weeks prior to randomisation)
Absolute neutrophil count (ANC) <1.5 x 10 (to the power of 9)/l
Platelet count <100 x 10 (to the power of 9)/l
Total bilirubin >1.5 upper limit of normal (ULN)
Aspartate Amino Transferase (AST), Alanine Amino Transferase (ALT), Alkaline Phosphate (Alk Phos) >2.5 upper limit of normal (ULN)
v) Patients who are pregnant or lacatating. Women of child bearing potential must have a confirmed negative pregnancy test at study entry
vi) Patients with a medical or psychological problem which, in the investigators' opinion, would interfere with treatment or follow-up
vii) Patients with either ocular or mucosal melanoma
viii) Patients who are currently enrolled in other concurrent experimental treatments or alternative therapies
ix) Patients cannot have received any other investigational agents or treatment (i.e. chemo, immuno, vaccine or radio therapy) within 30 days of commencing study
x) Patients should not be taking other agents known to interact with the study drug such as anti-convulsants
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation process will be coordinated centrally and sites will phone to request randomisation for a patient and confirm eligibility information by fax. Once randomised, the investigator and patient will be made aware of the study kit number.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation, gender will be used for stratification.
Manual telephone randomisation will be used to randomise patients.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2010
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Actual
17/01/2011
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Date of last participant enrolment
Anticipated
1/10/2014
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Actual
10/09/2014
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Date of last data collection
Anticipated
10/10/2016
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Actual
10/10/2016
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Sample size
Target
75
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Accrual to date
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Final
75
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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The Poche Centre, Melanoma Institute Australia - North Sydney
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Recruitment postcode(s) [1]
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2050 - Missenden Road
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Recruitment postcode(s) [2]
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2060 - North Sydney
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Melanoma Institute Australia
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Address [1]
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The Poche Centre
40 Rocklands Road North Sydney NSW 2060
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Country [1]
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Australia
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Funding source category [2]
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Government body
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Name [2]
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Cancer Institute NSW
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Address [2]
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Australian Technology Park
Biomedical Building
Suite 101
1 Central Avenue (off Garden Road)
Eveleigh NSW 2015
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Country [2]
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Australia
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Funding source category [3]
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Commercial sector/Industry
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Name [3]
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Blackmores Pty Ltd
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Address [3]
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20 Jubilee Avenue
Warriewood NSW 2102
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Country [3]
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Australia
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Funding source category [4]
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Commercial sector/Industry
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Name [4]
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Australia Post
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Address [4]
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P O Box 1018
Strawberry Hills NSW 2012
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Country [4]
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Melanoma and Skin Cancer Trial
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Address
Level 2, 553 St Kilda Road, Melbourne, Victoria 3004
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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University
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Name [1]
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National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC)
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Address [1]
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6-10 Mallett St
Camperdown NSW 2050
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Local Health District
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Ethics committee address [1]
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Research Development Office Royal Prince Alfred Hospital Missenden Road Camperdown NSW 2050
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/07/2009
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Approval date [1]
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27/08/2009
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Ethics approval number [1]
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HREC/09/RPAH/213
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Summary
Brief summary
This study aims to evaluate the safety and efficacy of high dose vitamin D therapy in patients who have primary melanoma which has been treated and are at high risk of recurrence. Who is it for? You may be eligible to join this study if you aged 18 to 79 years and have been diagnosed with cutaneous melanoma. Study details: Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive vitamin D3 tablets monthly for 24 months, whilst participants in the other group will receive a placebo (sugar pill). Participants will be followed-up for 24 months, in order to determine dose sufficiency, compliance, safety and progression free survival.
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Trial website
https://www.masc.org.au/completed-and-published-trials/
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Trial related presentations / publications
https://pubmed.ncbi.nlm.nih.gov/25343963/
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Public notes
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Contacts
Principal investigator
Name
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Dr Robyn Saw
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Address
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The Poche Centre
40 Rocklands Road North Sydney NSW 2060
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Country
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Australia
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Phone
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+ 61 2 9911 7210
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Fax
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+ 61 2 9954 9418
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Email
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Robyn.Saw@melanoma.org.au
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Contact person for public queries
Name
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Gabrielle Byars
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Address
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Melanoma and Skin Cancer Trials
553 St Kilda Road, Melbourne, Victoria 3004
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Country
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Australia
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Phone
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+61 3 9903 9022
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Fax
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Email
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hello@masc.org.au
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Contact person for scientific queries
Name
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Dr Robyn Saw
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Address
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The Poche Centre
40 Rocklands Road North Sydney NSW 2060
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Country
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Australia
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Phone
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+ 61 2 9911 7210
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Fax
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+ 61 2 9954 9418
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Email
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Robyn.Saw@melanoma.org.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Adjuvant therapy with high dose vitamin D following primary treatment of melanoma at high risk of recurrence: a placebo controlled randomised phase II trial (ANZMTG 02.09 Mel-D).
2014
https://dx.doi.org/10.1186/1471-2407-14-780
Embase
Vitamin D in melanoma: Controversies and potential role in combination with immune check-point inhibitors.
2018
https://dx.doi.org/10.1016/j.ctrv.2018.05.016
Embase
Relevance of Vitamin D in melanoma development, progression and therapy.
2020
https://dx.doi.org/10.21873/anticanres.13976
N.B. These documents automatically identified may not have been verified by the study sponsor.
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