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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study examines melanoma and nonmelanoma skin cancer in people diagnosed with vitiligo compared to matched controls.
For the primary analysis, this study examines the risk of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma in people diagnosed with vitiligo. It also examines actinic keratoses. In secondary analysis, this study examines the prevalence of skin cancer in people diagnosed with vitiligo compared to matched controls.
This study also examines whether the susceptibility to melanoma and nonmelanoma skin cancer may vary between different patient subgroups, e.g. ethnicity, those who undergo phototherapy or treatment with the new targeted biologic immunosuppressive therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. |
| |
| Controls | The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure of skin cancer of interest | Other | Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of New Onset Skin Cancer in Adult People Diagnosed With Vitiligo | Number of new onset skin cancer assessed prospectively in vitiligo cases and matched controls. The skin cancer outcome comprises of the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma. | 10 years from the index date |
| Number of New Onset Skin Cancers in the Female Sex Subgroup | Number of new onset skin cancers assessed prospectively in female vitiligo cases and matched controls. | 10 years from the index date |
| Number of New Onset Skin Cancers in the Male Sex Subgroup | Number of new onset skin cancers assessed prospectively in male vitiligo cases and matched controls. | 10 years from the index date |
| Number of New Onset Skin Cancers in the <45 Age Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged <45 | 10 years from the index date |
| Number of New Onset Skin Cancers in the 45-64 Age Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged 45-64 | 10 years from the index date |
| Number of New Onset Skin Cancers in the >=65 Age Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged >=65 | 10 years from the index date |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Skin Cancer in Adult People Diagnosed With Vitiligo | Skin cancer is defined as the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma. | At index date |
| Prevalence of Melanoma Skin Cancer in Adult People Diagnosed With Vitiligo |
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Inclusion Criteria:
Exclusion Criteria:
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This study will use routinely collected and collated data from Optimum Patient Care Research Database (OPCRD) to provide a broadly representative sample of the population of the UK.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew McGovern, MD | Momentum Data Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Momentum Data Ltd | London | WC1X 8QT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37146674 | Result | Ferguson J, Eleftheriadou V, Nesnas J. Risk of Melanoma and Nonmelanoma Skin Cancer in People with Vitiligo: United Kingdom Population-Based Cohort Study. J Invest Dermatol. 2023 Nov;143(11):2204-2210. doi: 10.1016/j.jid.2023.04.013. Epub 2023 May 3. |
| Label | URL |
|---|---|
| Main publication of final results | View source |
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OPCRD data can be accessed by bone fide researchers for specific research projects, subject to approval by Anonymised Data Ethics & Protocol Transparency (ADEPT) Committee. The data utilised for this study cannot be made available without such approval.
The data will be available subject to approvals for two years after the study publication date
Data sharing is subject to ADEPT committee approval
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| ID | Title | Description |
|---|---|---|
| FG000 | Cases | Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses. |
| FG001 | Controls | The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cases | Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses. |
| BG001 | Controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of New Onset Skin Cancer in Adult People Diagnosed With Vitiligo | Number of new onset skin cancer assessed prospectively in vitiligo cases and matched controls. The skin cancer outcome comprises of the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma. | Posted | Count of Participants | Participants | 10 years from the index date |
|
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cases | Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Andrew McGovern | Momentum Data Ltd | +44 7531221970 | andy.mcgovern@momentumdata.co.uk |
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| 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 | Jul 5, 2021 | Mar 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| D008545 | Melanoma |
| D002294 | Carcinoma, Squamous Cell |
| D002280 | Carcinoma, Basal Cell |
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Number of New Onset Skin Cancers in the White Ethnicity Subgroup |
Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those of white ethnicity |
| 10 years from the index date |
| Number of New Onset Skin Cancers in the Non-white Ethnicity Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those of non-white ethnicity | 10 years from the index date |
| Number of New Onset Skin Cancers in the Most Deprived Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those in the most deprived subgroup category | 10 years from the index date |
| Number of New Onset Skin Cancers in the Least Deprived Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those in the least deprived subgroup category | 10 years from the index date |
Prevalence of melanoma skin cancer in adult people diagnosed with vitiligo at or before recruitment |
| At index date. |
| Prevalence of Squamous Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo | Prevalence of squamous cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment | At index date. |
| Prevalence of Basal Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo | Prevalence of basal cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment | At index date. |
| Number of New Onset Actinic Keratoses in Adult People Diagnosed With Vitiligo | Number of new onset actinic keratoses in adult people assessed in vitiligo cases and matched controls. | 10 years from the index date |
| Prevalence of Actinic Keratoses in Adult People Diagnosed With Vitiligo | Prevalence of actinic keratoses in adult people diagnosed with vitiligo at or before recruitment | At index date. |
The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Index of Multiple Deprivation | Index of Multiple Deprivation (IMD) is a UK national deprivation measure of deprivation which is based on the patient postcode. IMD has been stratified into quintiles with IMD 1 representing most deprived and IMD 5 being the least deprived. | Median | Inter-Quartile Range | Quintile of deprivation |
|
|
|
| Primary | Number of New Onset Skin Cancers in the Female Sex Subgroup | Number of new onset skin cancers assessed prospectively in female vitiligo cases and matched controls. | The number of participants analyzed for this outcome is a subset of the overall population: female sex subgroup | Posted | Count of Participants | Participants | 10 years from the index date |
|
|
|
| Primary | Number of New Onset Skin Cancers in the Male Sex Subgroup | Number of new onset skin cancers assessed prospectively in male vitiligo cases and matched controls. | The number of participants analyzed for this outcome is a subset of the overall population: male sex subgroup | Posted | Count of Participants | Participants | 10 years from the index date |
|
|
|
| Primary | Number of New Onset Skin Cancers in the <45 Age Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged <45 | The number of participants analyzed for this outcome is a subset of the overall population:age less than 45 years subgroup | Posted | Count of Participants | Participants | 10 years from the index date |
|
|
|
| Primary | Number of New Onset Skin Cancers in the 45-64 Age Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged 45-64 | The number of participants analyzed for this outcome is a subset of the overall population:age 45 tp 64 years subgroup | Posted | Count of Participants | Participants | 10 years from the index date |
|
|
|
| Primary | Number of New Onset Skin Cancers in the >=65 Age Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged >=65 | The number of participants analyzed for this outcome is a subset of the overall population:age 65+ years subgroup | Posted | Count of Participants | Participants | 10 years from the index date |
|
|
|
| Primary | Number of New Onset Skin Cancers in the White Ethnicity Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those of white ethnicity | Posted | Count of Participants | Participants | 10 years from the index date |
|
|
|
| Primary | Number of New Onset Skin Cancers in the Non-white Ethnicity Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those of non-white ethnicity | Posted | Count of Participants | Participants | 10 years from the index date |
|
|
|
| Primary | Number of New Onset Skin Cancers in the Most Deprived Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those in the most deprived subgroup category | Posted | Count of Participants | Participants | 10 years from the index date |
|
|
|
| Primary | Number of New Onset Skin Cancers in the Least Deprived Subgroup | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those in the least deprived subgroup category | Posted | Count of Participants | Participants | 10 years from the index date |
|
|
|
| Secondary | Prevalence of Skin Cancer in Adult People Diagnosed With Vitiligo | Skin cancer is defined as the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma. | Posted | Count of Participants | Participants | At index date |
|
|
|
| Secondary | Prevalence of Melanoma Skin Cancer in Adult People Diagnosed With Vitiligo | Prevalence of melanoma skin cancer in adult people diagnosed with vitiligo at or before recruitment | Posted | Count of Participants | Participants | At index date. |
|
|
|
| Secondary | Prevalence of Squamous Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo | Prevalence of squamous cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment | Posted | Count of Participants | Participants | At index date. |
|
|
|
| Secondary | Prevalence of Basal Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo | Prevalence of basal cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment | Posted | Count of Participants | Participants | At index date. |
|
|
|
| Secondary | Number of New Onset Actinic Keratoses in Adult People Diagnosed With Vitiligo | Number of new onset actinic keratoses in adult people assessed in vitiligo cases and matched controls. | Posted | Count of Participants | Participants | 10 years from the index date |
|
|
|
| Secondary | Prevalence of Actinic Keratoses in Adult People Diagnosed With Vitiligo | Prevalence of actinic keratoses in adult people diagnosed with vitiligo at or before recruitment | Posted | Count of Participants | Participants | At index date. |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Controls | The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018307 | Neoplasms, Squamous Cell |
| D018295 | Neoplasms, Basal Cell |
| D011230 | Precancerous Conditions |
| D007642 | Keratosis |