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Active, not recruitingNCT05976061Updated Apr 4, 2025

High- and Low-risk Actinic Keratosis Referrals to Secondary Care

An observational study in Actinic Keratoses, sponsored by Maastricht University Medical Center. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Maastricht University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,379
Ages
18 Years and older
Sex
All
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Study summary

This study evaluates the implementation of the General Practitioners guidelines 'Suspicious Skin Lesions' and investigated whether their publication and implementation has led to a reduction in the proportion of referrals of low-risk patients with actinic keratosis to secondary care, after publication of the General Practitioners guidelines and implementation activities.

Read the detailed description

In the Dutch healthcare system, patients are first examined by the general practitioner who decides whether a referral to a dermatologist is indicated. Both general practitioners and dermatologists can diagnose and treat patients with actinic keratosis. Therefore, it is necessary to distinguish which patients the general practitioner should refer to a dermatologist and which patients are suitable to be treated by the general practitioner.

This retrospective data study evaluates the proportion of low risk actinic keratosis patients in 2019 en 2018.

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Conditions studied

  • Actinic Keratoses

Keywords

  • General Practitioners guidelines
  • actinic keratosis
  • general physician
  • dermatology
  • low-risk patients
  • referrals
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In context

Keratosis, Actinic

364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.

This study's enrollment of 3,379 is above the median of 179 across 35 observational studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Data from patients are collected retrospectively using the Electronic health records. Patients were selected based on the diagnosis-treatment-combination (DTC) 17 (premalignant lesion) and DTC 14 (cutaneous malignancy) that was registered from January 2018 to December 2019 by the dermatologist.

Inclusion criteria

  • patients of 18 years and older
  • referred to dermatologist for suspicion of actinic keratosis and diagnosed as actinic keratosis by the dermatologist
  • treated at MaastrichtUMC+ or TergooiHospital

Exclusion criteria

Exclusion Criteria:

  • different diagnosis than actinic keratosis
  • referred by a different specialist than the general practitioner
  • referred with multiple problems
  • referred for a second opinion
  • if the patients was treated as different diagnosis than actinic keratosis by general practitioner
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,379 participants (actual)
Patient registry
No

Groups and cohorts

  • Low risk patients

    Low risk actinic keratosis patients referred by the general practitioner and diagnosed as actinic keratosis by the dermatologist in 2018 and 2019.

  • High risk patients

    High risk actinic keratosis patients referred by the general practitioner and diagnosed as actinic keratosis by the dermatologist in 2018 and 2019.

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What researchers measure

Primary outcomes

  1. Change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients.

    The change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients referred by the general practitioner to the dermatologist. The definition of low-risk actinic keratosis patients was based on the General Practitioners guidelines 'Suspicious skin lesions' (published in 2017). Patients were defined as low-risk when they were not immunocompromised, did not have a cutaneous malignancy in their medical history, did not have previous treatment or if they did not have extensive lesions.

    Time frame: 2018 compared to 2019 (2 years)

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Study locations

1 site
  • Ellen Oyen
    Maastricht, Netherlands
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05976061
Lead sponsor
Maastricht University Medical Center
Collaborators
Tergooi Hospital
Responsible party
Sponsor
First posted
Aug 4, 2023
Start date
Mar 1, 2021
Primary completion
Sep 1, 2023
Completion
Dec 1, 2025 (estimated)
Last update
Apr 4, 2025

Study contacts

Klara Mosterd, prof.dr.
principal investigator · Maastricht UMC+
Maud Jansen, dr.
principal investigator · Maastricht UMC+

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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