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

January 13, 2025 updated by: Momentum Data

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

75771

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.
Other: Exposure of skin cancer of interest
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.
Other: Exposure of skin cancer of interest
Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years from the index date
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.
10 years from the index date
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.
10 years from the index date
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
10 years from the index date
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
10 years from the index date
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
10 years from the index date
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
10 years from the index date
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
10 years from the index date
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 years from the index date
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
10 years from the index date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At index date
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
At index date.
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
At index date.
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
At index date.
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.
10 years from the index date
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
At index date.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Momentum Data

Collaborators

Pfizer

Investigators

  • Study Director: Andrew McGovern, MD, Momentum Data Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 20, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The data will be available subject to approvals for two years after the study publication date

IPD Sharing Access Criteria

Data sharing is subject to ADEPT committee approval

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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