VitiligoNCT04969419
Incidence of Melanoma and Non-melanoma Skin Cancer in People With Vitiligo
An observational study of Vitiligo and Melanoma (Skin), run by Momentum Data at 1 site in United Kingdom.
Trial summary
This study examines melanoma and nonmelanoma skin cancer in people diagnosed with vitiligo compared to matched controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo, Melanoma (Skin), Nonmelanoma Skin Cancer
- What is being tested?
- Exposure of skin cancer of interest
- How many people
- 75,771 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jun 2021to 4 Apr 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitiligo, Melanoma (Skin), Nonmelanoma Skin Cancer, Squamous Cell Carcinoma, Basal Cell Carcinoma, Actinic Keratoses
- Being tested
- Exposure of skin cancer of interest
- Medical subject headings
- Vitiligo, Melanoma, Carcinoma, Squamous Cell, Carcinoma, Basal Cell, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure of skin cancer of interestOther
Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Receives: 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. Receives: Other: Exposure of skin cancer of interest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 10 years from the index date
Secondary outcomes (6)
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.
Measured: At index date
Prevalence of Melanoma Skin Cancer in Adult People Diagnosed With Vitiligo
Prevalence of melanoma skin cancer in adult people diagnosed with vitiligo at or before recruitment
Measured: At index date.
Prevalence of Squamous Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo
Prevalence of squamous cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment
Measured: At index date.
Prevalence of Basal Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo
Prevalence of basal cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment
Measured: At index date.
Number of New Onset Actinic Keratoses in Adult People Diagnosed With Vitiligo
Number of new onset actinic keratoses in adult people assessed in vitiligo cases and matched controls.
Measured: 10 years from the index date
Prevalence of Actinic Keratoses in Adult People Diagnosed With Vitiligo
Prevalence of actinic keratoses in adult people diagnosed with vitiligo at or before recruitment
Measured: At index date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start18 Jun 2021
- Primary completion31 Mar 2022
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 75,771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Data
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Andrew McGovern, MD, Study director, Momentum Data Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969419
- Sponsor's protocol ID
- P045
- Status last verified
- Jan 2025
- First submitted
- 1 Jul 2021
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37146674
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Melanoma and Non-melanoma Skin Cancer in People With Vitiligo: A Case-control Study in the United Kingdom, 2009-2020
- ClinicalTrials.gov ID
- NCT04969419
- Acronym / sponsor ID
- P045
- Conditions
- Vitiligo, Melanoma (Skin), Nonmelanoma Skin Cancer, Squamous Cell Carcinoma, Basal Cell Carcinoma, Actinic Keratoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75,771 participants (actual)
- Lead sponsor
- Momentum DataIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines melanoma and nonmelanoma skin cancer in people diagnosed with vitiligo compared to matched controls.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Exposure of skin cancer of interestPatients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. |
| Controls | – | Other: Exposure of skin cancer of interestThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure of skin cancer of interestMelanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses. | Other | Cases, Controls |
Primary outcome
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.
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.
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.
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
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
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
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
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
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
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
6 secondary outcomes
Prevalence of Skin Cancer in Adult People Diagnosed With Vitiligo
Time frame: At index date
Prevalence of Melanoma 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
Time frame: At index date.
Prevalence of Basal Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo
Time frame: At index date.
Number of New Onset Actinic Keratoses in Adult People Diagnosed With Vitiligo
Time frame: 10 years from the index date
Prevalence of Actinic Keratoses in Adult People Diagnosed With Vitiligo
Time frame: At index date.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37146674Ferguson 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.
- Main publication of final resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew McGovern, MD study director
Momentum Data Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo and Melanoma (Skin), run by Momentum Data at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of New Onset Skin Cancer in Adult People Diagnosed With Vitiligo (time frame: 10 years from the index date). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04969419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.