Clinical trial NCT04969419: Incidence of Melanoma and Non-melanoma Skin Cancer in People With Vitiligo
Official title: Incidence of Melanoma and Non-melanoma Skin Cancer in People With Vitiligo: A Case-control Study in the United Kingdom, 2009-2020
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitiligo
Melanoma (Skin)
Nonmelanoma Skin Cancer
Squamous Cell Carcinoma
Basal Cell Carcinoma
Actinic Keratoses
Lead sponsor: Momentum Data
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2021-07-20
Enrollment: 75771
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: This study examines melanoma and nonmelanoma skin cancer in people diagnosed with vitiligo compared to matched controls.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All eligible adult patients (aged ≥ 18) registered with General Practioner (GP) practices contributing data to OPCRD between January 1, 2010 and December 31, 2020, were eligible for inclusion in the study. People diagnosed with vitiligo prior to the study period (prevalent vitiligo) and people newly diagnosed with vitiligo during the study period (incident vitiligo) are included as cases.

Exclusion Criteria:

* People actively registered with the GP practice at that date without a history of vitiligo require a minimum one-year registration with their GP practice.

Primary outcomes:
measure: Number of New Onset Skin Cancer in Adult People Diagnosed With Vitiligo
timeFrame: 10 years from the index date
measure: Number of New Onset Skin Cancers in the Female Sex Subgroup
timeFrame: 10 years from the index date
measure: Number of New Onset Skin Cancers in the Male Sex Subgroup
timeFrame: 10 years from the index date
measure: Number of New Onset Skin Cancers in the <45 Age Subgroup
timeFrame: 10 years from the index date
measure: Number of New Onset Skin Cancers in the 45-64 Age Subgroup
timeFrame: 10 years from the index date
measure: Number of New Onset Skin Cancers in the >=65 Age Subgroup
timeFrame: 10 years from the index date
measure: Number of New Onset Skin Cancers in the White Ethnicity Subgroup
timeFrame: 10 years from the index date
measure: Number of New Onset Skin Cancers in the Non-white Ethnicity Subgroup
timeFrame: 10 years from the index date
measure: Number of New Onset Skin Cancers in the Most Deprived Subgroup
timeFrame: 10 years from the index date
measure: Number of New Onset Skin Cancers in the Least Deprived Subgroup
timeFrame: 10 years from the index date
Secondary outcomes:
measure: Prevalence of Skin Cancer in Adult People Diagnosed With Vitiligo
timeFrame: At index date
measure: Prevalence of Melanoma Skin Cancer in Adult People Diagnosed With Vitiligo
timeFrame: At index date.
measure: Prevalence of Squamous Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo
timeFrame: At index date.
measure: Prevalence of Basal Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo
timeFrame: At index date.
measure: Number of New Onset Actinic Keratoses in Adult People Diagnosed With Vitiligo
timeFrame: 10 years from the index date
measure: Prevalence of Actinic Keratoses in Adult People Diagnosed With Vitiligo
timeFrame: At index date.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Momentum Data Ltd
Study officials:
affiliation: Momentum Data Ltd
name: Andrew McGovern, MD
role: STUDY_DIRECTOR
References:
citation: 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.