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

Completed

• Conditions: Nonmelanoma Skin Cancer; Vitiligo; Melanoma (Skin); Actinic Keratoses; Squamous Cell Carcinoma; Basal Cell Carcinoma

• Registration Number: NCT04969419
• Lead Sponsor: Momentum Data

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.

Study Timeline

• Study Start: 2021-06-18
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-20
• Primary Completion: 2022-03-31
• Study Completion: 2023-04-04
• Results First Submitted: 2024-10-22
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Results First Posted: 2025-01-14
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75771

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of New Onset Skin Cancers in the >=65 Age Subgroup	10 years from the index date	Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged \>=65
Number of New Onset Skin Cancers in the White Ethnicity Subgroup	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
Number of New Onset Skin Cancers in the Non-white Ethnicity Subgroup	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
Number of New Onset Skin Cancers in the Most Deprived Subgroup	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
Number of New Onset Skin Cancers in the Least Deprived Subgroup	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
Number of New Onset Skin Cancers in the <45 Age Subgroup	10 years from the index date	Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged \<45
Number of New Onset Skin Cancers in the 45-64 Age Subgroup	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
Number of New Onset Skin Cancer in Adult People Diagnosed With Vitiligo	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.
Number of New Onset Skin Cancers in the Female Sex Subgroup	10 years from the index date	Number of new onset skin cancers assessed prospectively in female vitiligo cases and matched controls.
Number of New Onset Skin Cancers in the Male Sex Subgroup	10 years from the index date	Number of new onset skin cancers assessed prospectively in male vitiligo cases and matched controls.

Secondary Outcome Measures

Name	Time	Method
Prevalence of Basal Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo	At index date.	Prevalence of basal cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment
Prevalence of Skin Cancer in Adult People Diagnosed With Vitiligo	At index date	Skin cancer is defined as the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma.
Number of New Onset Actinic Keratoses in Adult People Diagnosed With Vitiligo	10 years from the index date	Number of new onset actinic keratoses in adult people assessed in vitiligo cases and matched controls.
Prevalence of Melanoma Skin Cancer in Adult People Diagnosed With Vitiligo	At index date.	Prevalence of melanoma skin cancer in adult people diagnosed with vitiligo at or before recruitment
Prevalence of Squamous Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo	At index date.	Prevalence of squamous cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment
Prevalence of Actinic Keratoses in Adult People Diagnosed With Vitiligo	At index date.	Prevalence of actinic keratoses in adult people diagnosed with vitiligo at or before recruitment

Trial Locations

Locations (1)

Momentum Data Ltd; 🇬🇧 London, United Kingdom