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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04969419
• Other study ID #: P045
• Status: Completed
• Start date: June 18, 2021
• Est. completion date: April 4, 2023

Study information

• Verified date: August 2023
• Source: Momentum Data
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45000
• Est. completion date: April 4, 2023
• Est. primary completion date: March 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Keratoses
• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Keratosis
• Keratosis, Actinic
• Melanoma
• Melanoma (Skin)
• Nonmelanoma Skin Cancer
• Skin Neoplasms
• Squamous Cell Carcinoma
• Vitiligo

Intervention

Other:
• Exposure of skin cancer of interest
Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.

Locations

Country	Name	City	State
United Kingdom	Momentum Data Ltd	London

Sponsors (2)

Lead Sponsor	Collaborator
Momentum Data	Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of new onset skin cancer in adult people diagnosed with vitiligo	Risk 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
Primary	Risk of new onset skin cancer in adult people diagnosed with vitiligo by sociodemographic subgroups	Risk of new onset skin cancer assessed prospectively in vitiligo cases and matched controls. Sociodemographic subgroups defined by age, sex, socioeconomic status and ethnicity.	10 years from the index date
Secondary	Prevalence of skin cancer in adult people diagnosed with vitiligo	Skin cancer is defined as the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma.	At index date
Secondary	Prevalence of individual skin cancers in adult people diagnosed with vitiligo	Melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma, and actinic keratoses.	At index date.