Actinic KeratosesNCT05976061
High- and Low-risk Actinic Keratosis Referrals to Secondary Care
An observational study of Actinic Keratoses, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- How many people
- 3,379 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2021to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High- and Low-risk Actinic Keratosis Referrals to Secondary Care. Implementation of the General Practitioners Guidelines for Actinic Keratosis Patients.
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.
- Conditions
- Actinic Keratoses
- Keywords
- General Practitioners guidelines, actinic keratosis, general physician, dermatology, low-risk patients, referrals
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2018 compared to 2019 (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Mar 2021
- Primary completion1 Sep 2023
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- 3,379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tergooi Hospital
- Responsible party
- Sponsor
- Investigators
- Klara Mosterd, prof.dr., Principal investigator, Maastricht UMCMaud Jansen, dr., Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976061
- Sponsor's protocol ID
- 2020-2432
- Status last verified
- Apr 2025
- First submitted
- 20 Jul 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High- and Low-risk Actinic Keratosis Referrals to Secondary Care. Implementation of the General Practitioners Guidelines for Actinic Keratosis Patients.
- ClinicalTrials.gov ID
- NCT05976061
- Acronym / sponsor ID
- 2020-2432
- Conditions
- Actinic Keratoses
- Keywords
- General Practitioners guidelines, actinic keratosis, general physician, dermatology, low-risk patients, referrals
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,379 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Tergooi Hospital
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients.
Time frame: 2018 compared to 2019 (2 years)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
Related trials for Actinic Keratoses
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 4
Cryotherapy in Combination With Red Light PDT for Actinic Keratosis of Full Face
Actinic Keratoses
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.
Klara Mosterd, prof.dr. principal investigator
Maastricht UMC
Maud Jansen, dr. principal investigator
Maastricht UMC
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 Actinic Keratoses, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Apr 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients. (time frame: 2018 compared to 2019 (2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2025.