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Completed

NCT Number: NCT04969419

Incidence of Melanoma and Non-melanoma Skin Cancer in People With Vitiligo

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

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Key information

Conditions

Vitiligo Actinic Keratoses Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Hypopigmentation Keratosis Keratosis, Actinic Melanoma Melanoma (Skin) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nonmelanoma Skin Cancer Pigmentation Disorders Precancerous Conditions Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exposure of skin cancer of interest

Other

Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.

Primary outcomes

  1. Number of New Onset Skin Cancer in Adult People Diagnosed With Vitiligo

    Time frame: 10 years from the index date

    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.

  2. Number of New Onset Skin Cancers in the Female Sex Subgroup

    Time frame: 10 years from the index date

    Number of new onset skin cancers assessed prospectively in female vitiligo cases and matched controls.

  3. Number of New Onset Skin Cancers in the Male Sex Subgroup

    Time frame: 10 years from the index date

    Number of new onset skin cancers assessed prospectively in male vitiligo cases and matched controls.

  4. Number of New Onset Skin Cancers in the <45 Age Subgroup

    Time frame: 10 years from the index date

    Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged <45

  5. Number of New Onset Skin Cancers in the 45-64 Age Subgroup

    Time frame: 10 years from the index date

    Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged 45-64

  6. Number of New Onset Skin Cancers in the >=65 Age Subgroup

    Time frame: 10 years from the index date

    Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged >=65

  7. Number of New Onset Skin Cancers in the White Ethnicity Subgroup

    Time frame: 10 years from the index date

    Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those of white ethnicity

  8. Number of New Onset Skin Cancers in the Non-white Ethnicity Subgroup

    Time frame: 10 years from the index date

    Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those of non-white ethnicity

  9. Number of New Onset Skin Cancers in the Most Deprived Subgroup

    Time frame: 10 years from the index date

    Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those in the most deprived subgroup category

  10. Number of New Onset Skin Cancers in the Least Deprived Subgroup

    Time frame: 10 years from the index date

    Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those in the least deprived subgroup category

Secondary outcomes

  1. Prevalence of Skin Cancer in Adult People Diagnosed With Vitiligo

    Time frame: At index date

    Skin cancer is defined as the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma.

  2. Prevalence of Melanoma Skin Cancer in Adult People Diagnosed With Vitiligo

    Time frame: At index date.

    Prevalence of melanoma skin cancer in adult people diagnosed with vitiligo at or before recruitment

  3. Prevalence of Squamous Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo

    Time frame: At index date.

    Prevalence of squamous cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment

  4. Prevalence of Basal Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo

    Time frame: At index date.

    Prevalence of basal cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment

  5. Number of New Onset Actinic Keratoses in Adult People Diagnosed With Vitiligo

    Time frame: 10 years from the index date

    Number of new onset actinic keratoses in adult people assessed in vitiligo cases and matched controls.

  6. Prevalence of Actinic Keratoses in Adult People Diagnosed With Vitiligo

    Time frame: At index date.

    Prevalence of actinic keratoses in adult people diagnosed with vitiligo at or before recruitment

Sponsors and collaborators

Lead sponsor

Momentum Data

Industry

Collaborators

  • Pfizer

Registry information

Official study title

Incidence of Melanoma and Non-melanoma Skin Cancer in People With Vitiligo: A Case-control Study in the United Kingdom, 2009-2020

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 20, 2021
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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