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

Sponsor
Momentum Data (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04969419
Collaborator
Pfizer (Industry)
45,000
1
8.4
5350.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Exposure of skin cancer of interest

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 Design

Study Type:
Observational
Actual Enrollment :
45000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Incidence of Melanoma and Non-melanoma Skin Cancer in People With Vitiligo: A Case-control Study in the United Kingdom, 2009-2020
Actual Study Start Date :
Jun 18, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Risk of new onset skin cancer in adult people diagnosed with vitiligo [10 years from the index date]

    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.

  2. Risk of new onset skin cancer in adult people diagnosed with vitiligo by sociodemographic subgroups [10 years from the index date]

    Risk of new onset skin cancer assessed prospectively in vitiligo cases and matched controls. Sociodemographic subgroups defined by age, sex, socioeconomic status and ethnicity.

Secondary Outcome Measures

  1. 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.

  2. Prevalence of individual skin cancers in adult people diagnosed with vitiligo [At index date.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Momentum Data Ltd London United Kingdom WC1X 8QT

Sponsors and Collaborators

  • Momentum Data
  • Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Momentum Data
ClinicalTrials.gov Identifier:
NCT04969419
Other Study ID Numbers:
  • P045
First Posted:
Jul 20, 2021
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2021