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

NCT04969419 | Completed Results

• 1 other identifier: P045
• Study Type: observational
• Target: 75,771
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (10)

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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (6)

• Prevalence of Skin Cancer in Adult People Diagnosed With Vitiligo

  At index date

• Prevalence of Melanoma 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 index date.

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

  At index date.

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

  10 years from the index date

Study Arms (2)

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

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

Interventions

Exposure of skin cancer of interest OTHER

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

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Momentum Data: lead
• Pfizer: collaborator

Study Sites (1)

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37146674 RESULT

Related Links

• Main publication of final results

MeSH Terms

Conditions

Vitiligo; Melanoma; Carcinoma, Squamous Cell; Carcinoma, Basal Cell; Keratosis, Actinic

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Neoplasms, Basal Cell; Precancerous Conditions; Keratosis

Results Point of Contact

• Title: Dr Andrew McGovern
• Organization: Momentum Data Ltd

andy.mcgovern@momentumdata.co.uk

+44 7531221970

Study Officials

• Andrew McGovern, MD

  Momentum Data Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 20, 2021
• Study Start: June 18, 2021
• Primary Completion: March 31, 2022
• Study Completion: April 4, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available subject to approvals for two years after the study publication date
• Access Criteria: Data sharing is subject to ADEPT committee approval

Locations

GB (1)