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

NCT ID: NCT04969419

Last Updated: 2025-01-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75771 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-18

Study Completion Date

2023-04-04

Brief Summary

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

Detailed Description

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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.

Conditions

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Vitiligo Melanoma (Skin) Nonmelanoma Skin Cancer Squamous Cell Carcinoma Basal Cell Carcinoma Actinic Keratoses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Intervention Type OTHER

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

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

Intervention Type OTHER

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

Interventions

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Exposure of skin cancer of interest

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Momentum Data

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew McGovern, MD

Role: STUDY_DIRECTOR

Momentum Data Ltd

Locations

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Momentum Data Ltd

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 37146674 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://doi.org/10.1016/j.jid.2023.04.013

Main publication of final results

Other Identifiers

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P045

Identifier Type: -

Identifier Source: org_study_id

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