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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002125-30 | EudraCT Number |
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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Active Comparator | Every month 100 000 units of Vitamin D in syringe oral dispenser is taken . Study duration is maximum 3,5 years or until relapse occurs |
|
| Placebo: Oil | Placebo Comparator | Every month 100 000 units of vitamin D in syringe Oral dispenser is taken. Study duration is maximum of 3.5 years or until relapse occurs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Free Survival | Disease free survival will be the primary endpoint of this phase III trial. Study duration for one patient is maximum 9 years and 7 months. Patients are supplemented with studymedication (Vitamin D or placebo) for maximum 3.5 years. This is the treatment period. After the treatment period (in which the patients take study medication, placebo or Vitamin D), there is the follow-up period, no more study medication is taken, the study is still double blind, and the patients are followed at the clinical department for relapse and/or death. | study duration maximum 9 years and 7 months or until relapse |
| Measure | Description | Time Frame |
|---|---|---|
| Melanoma Subtype, as Assessed Clinically and Histologically | Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically. | Time at diagnosis |
| Melanoma Site, as Clinically Recorded |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints:Incidence and Severity of Adverse Events | Incidence and severity of adverse events will be recorded every 3 months up to final study visit (from the treatment period). | study duration maximum 3.5 years (Treatment period) or until relapse |
Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Marjan Garmyn, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen, Dermatology | Edegem | 2650 | Belgium | |||
| UZLeuven Gasthuisberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28835228 | Background | De Smedt J, Van Kelst S, Boecxstaens V, Stas M, Bogaerts K, Vanderschueren D, Aura C, Vandenberghe K, Lambrechts D, Wolter P, Bechter O, Nikkels A, Strobbe T, Emri G, Marasigan V, Garmyn M. Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial. BMC Cancer. 2017 Aug 23;17(1):562. doi: 10.1186/s12885-017-3538-4. | |
| 38913652 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D | Every month 100 000 units of Vitamin D in syringe oral dispenser is taken . Study duration is maximum 3,5 years or until relapse occurs Vitamin D: - prospective interventional randomized double blind placebo controlled trail
|
| FG001 | Placebo: Oil | Every month 100 000 units of vitamin D in syringe Oral dispenser is taken. Study duration is maximum of 3.5 years or until relapse occurs Oil |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
|
| |||||||||||||||||||||
| Follow-up Period |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D | Every month 100 000 units of Vitamin D in syringe oral dispenser is taken . Study duration is maximum 3,5 years or until relapse occurs Vitamin D: - prospective interventional randomized double blind placebo controlled trail
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relapse Free Survival | Disease free survival will be the primary endpoint of this phase III trial. Study duration for one patient is maximum 9 years and 7 months. Patients are supplemented with studymedication (Vitamin D or placebo) for maximum 3.5 years. This is the treatment period. After the treatment period (in which the patients take study medication, placebo or Vitamin D), there is the follow-up period, no more study medication is taken, the study is still double blind, and the patients are followed at the clinical department for relapse and/or death. | Posted | Count of Participants | Participants | study duration maximum 9 years and 7 months or until relapse |
|
In this study, the collection period for adverse events and serious Adverse events starts at the randomisation and ends when the patient completes the Treatment period of the study, serious and/or other adverse events were assessed up to 3.5 years. All-Cause Mortality was monitored for maximum 9 years and 7 months.
The investigator will use the following terms te assess the severity of the adverse event: mild, moderate severe.
The investigator will use the follwing causality terms to assess the relationship of teh adverse event or clinical efficacy to the use of the investigational medicinal product: reasonable causal relationship or not.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D | Every month 100 000 units of Vitamin D in syringe oral dispenser is taken . Study duration is maximum 3,5 years or until relapse occurs Vitamin D: - prospective interventional randomized double blind placebo controlled trail
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. M. Garmyn | UZLeuven | 0032 16 33 79 50 | marjan.garmyn@uzleuven.be |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2021 | Oct 8, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000096142 | Melanoma, Cutaneous Malignant |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
Not provided
Not provided
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
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Not provided
Not provided
Not provided
Not provided
|
|
| Placebo: Oil | Drug |
|
|
Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded.
| Time at diagnosis |
| 25(OH)D3 Serum Levels | 25(OH)D3 serum levels will be recorded at diagnosis and at 6 months intervals up to final study visit. | study duration maximum 3.5 years (Treatment period) or until relapse |
| Stage of Melanoma Patient | Stage of melanoma patient at diagnosis according to the 8th American Joint Committee of Cancer (AJCC) Melanoma staging and classification. The eighth edition of the AJCC staging system is currently the most widely accepted and standardized approach to melanoma staging and classification at initial diagnosis. Melanoma staging is based on the American Joint Committee on Cancer (AJCC) staging system that uses three key pieces of information for assigning Tumor-Node-Metastasis (TNM) classifications. AJCC staging ifacilitates accurate risk stratification and is essential to guide patient treatment. The higher the stage, the more severe the melanoma. | Time at diagnosis |
| Leuven |
| 3000 |
| Belgium |
| Chef de Service du Service Universitaire de Dermatologie | Liège | 4000 | Belgium |
| Dep. of Dermatology, Medical and Health Science Center University of Debrecen | Debrecen | 4032 | Hungary |
| De Smedt J, Van Kelst S, Janssen L, Marasigan V, Boecxstaens V, Bogaerts K, Belmans A, Vanderschueren D, Vandenberghe K, Bechter O, Aura C, Lambrechts D, Strobbe T, Emri G, Nikkels A, Garmyn M. High-dose vitamin D supplementation does not improve outcome in a cutaneous melanoma population: results of a randomized double-blind placebo-controlled study (ViDMe trial). Br J Dermatol. 2024 Nov 18;191(6):886-896. doi: 10.1093/bjd/ljae257. |
| 38348498 | Result | De Smedt J, Aura C, Van Kelst S, Janssen L, Marasigan V, Boecxstaens V, Stas M, Bogaerts K, Belmans A, Cleynen I, Vanderschueren D, Vandenberghe K, Bechter O, Nikkels A, Strobbe T, Emri G, Lambrechts D, Garmyn M. Clinical and genetic determinants of vitamin D receptor expression in cutaneous melanoma patients. Melanoma Res. 2024 Apr 1;34(2):125-133. doi: 10.1097/CMR.0000000000000929. Epub 2024 Feb 13. |
| 35312026 | Result | De Smedt J, Van Kelst S, Janssen L, Marasigan V, Boecxstaens V, Stas M, Vanderschueren D, Guler I, Bogaerts K, Vandenberghe K, Bechter O, Billen J, Nikkels A, Strobbe T, Emri G, Lambrechts D, Garmyn M. Determinants of 25-hydroxyvitamin D Status in a Cutaneous Melanoma Population. Acta Derm Venereol. 2022 Apr 8;102:adv00692. doi: 10.2340/actadv.v102.262. |
| Personal |
|
| NOT COMPLETED |
|
| BG001 | Placebo: Oil | Every month 100 000 units of vitamin D in syringe Oral dispenser is taken. Study duration is maximum of 3.5 years or until relapse occurs oil |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Education (highest level) | Count of Participants | Participants |
|
| Current smoking | Count of Participants | Participants |
|
| OG001 | Placebo: Oil | Every month 100 000 units of vitamin D in syringe Oral dispenser is taken. Study duration is maximum of 3.5 years or until relapse occurs Oil |
|
|
|
| Secondary | Melanoma Subtype, as Assessed Clinically and Histologically | Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically. | Posted | Count of Participants | Participants | Time at diagnosis |
|
|
|
| Secondary | Melanoma Site, as Clinically Recorded | Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded. | Posted | Count of Participants | Participants | Time at diagnosis |
|
|
|
| Secondary | 25(OH)D3 Serum Levels | 25(OH)D3 serum levels will be recorded at diagnosis and at 6 months intervals up to final study visit. | The number of patients differs from baseline with the other time points for different reasons: patient was already End of study, no sample taken because of various reasons,... | Posted | Mean | Standard Deviation | ng/ml | study duration maximum 3.5 years (Treatment period) or until relapse |
|
|
|
| Secondary | Stage of Melanoma Patient | Stage of melanoma patient at diagnosis according to the 8th American Joint Committee of Cancer (AJCC) Melanoma staging and classification. The eighth edition of the AJCC staging system is currently the most widely accepted and standardized approach to melanoma staging and classification at initial diagnosis. Melanoma staging is based on the American Joint Committee on Cancer (AJCC) staging system that uses three key pieces of information for assigning Tumor-Node-Metastasis (TNM) classifications. AJCC staging ifacilitates accurate risk stratification and is essential to guide patient treatment. The higher the stage, the more severe the melanoma. | Posted | Count of Participants | Participants | Time at diagnosis |
|
|
|
| Other Pre-specified | Safety Endpoints:Incidence and Severity of Adverse Events | Incidence and severity of adverse events will be recorded every 3 months up to final study visit (from the treatment period). | Posted | Number | Events | study duration maximum 3.5 years (Treatment period) or until relapse |
|
|
|
| 13 |
| 218 |
| 28 |
| 218 |
| 180 |
| 218 |
| EG001 | Placebo: Oil | Every month 100 000 units of vitamin D in syringe Oral dispenser is taken. Study duration is maximum of 3.5 years or until relapse occurs Oil | 13 | 218 | 33 | 218 | 178 | 218 |
|
| Vascular disorders | Vascular disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (5.1) | Non-systematic Assessment |
|
| General disorders and administration site conditions | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Ear and labyrinth disorders | Ear and labyrinth disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Eye disorders | Eye disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Endocrine disorders | Endocrine disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (5.1) | Non-systematic Assessment |
|
|
| Vascular disorders | Vascular disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (5.1) | Non-systematic Assessment |
|
| Pregnancy, puerperium and perinatal conditions | Pregnancy, puerperium and perinatal conditions | MedDRA (5.1) | Non-systematic Assessment |
|
| General disorders and administration site conditions | General disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Product issues | Product Issues | MedDRA (5.1) | Non-systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Ear and labyrinth disorders | Ear and labyrinth disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Eye disorders | Eye disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Endocrine disorders | Endocrine disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Non-systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (5.1) | Non-systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (5.1) | Non-systematic Assessment |
|
Not provided
Not provided
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| Vocational training |
|
| Vocational university |
|
| University graduated |
|
| Other |
|
| Unknown |
|
| Never Smoked |
|
| Unknown |
|
| Acrolentigineus melanoma |
|
| Lentigo maligna melanoma |
|
| Unknown |
|
| Other |
|
| Foot |
|
| Genitals |
|
| Head-neck |
|
| Leg |
|
| Back |
|
| At Month 6 |
|
|
| At Month 12 |
|
|
| At Month 18 |
|
|
| At Month 24 |
|
|
| At Month 30 |
|
|
| At Month 36 |
|
|
| End of study (end of study medication) |
|
|
| IIA |
|
| IIB |
|
| IIC |
|
| IIIA |
|
| IIIB |
|
| IIIC |
|
| IIID |
|
| Unkown |
|