AI decision support for detecting skin cancer in primary care
Official title: Artificial Intelligent Decision Support for Skin Cancer Diagnostics in Primary Care - a Multicentre Randomized Controlled Trial.
Run by Linkoeping University · NCT06932172 · Data updated 2026-11-12
This study will test whether an AI tool called Dermalyser helps primary care clinicians tell skin cancers from harmless skin lesions when patients come in with suspicious spots.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Linkoeping University Government |
| Locations | 8 sites (Finspång, Docent and 7 other locations) |
| Status | Recruiting |
| Started | November 4, 2025 |
| Main results expected | May 31, 2027 |
| Study ends | December 31, 2031 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT06932172 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who attend a participating primary care center with one or more skin lesions that they or their clinician find suspicious for skin cancer and who can give informed consent are eligible.
✕Probably not a fit
People with darker brown or black skin (Fitzpatrick skin types V–VI) are excluded from the study and therefore will not receive potential benefits from this specific trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a cluster-randomized trial conducted at about 30 primary care centers across Sweden, Germany, Scotland, the Netherlands, and Australia. Participating centers are randomized to either use the Dermalyser AI decision support tool or continue standard clinical assessment. The trial prospectively compares diagnostic accuracy, reliability, and clinical utility of the AI-assisted pathway versus usual care for patients presenting with suspicious skin lesions. Outcomes will capture how well the tool distinguishes malignant from benign lesions and how it affects clinical decisions in routine primary care.
Why it matters
Potential benefit: If successful, the AI tool could lead to faster and more accurate identification of skin cancers in primary care, reducing missed cancers and unnecessary referrals.
How similar studies have gone: Numerous retrospective and image-based studies report high AI accuracy for detecting skin cancer from dermatoscopic images, but prospective evaluations in real-world primary care settings are scarce.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients attending a primary care facility in order to have one or more skin lesions checked for skin cancer, or patients presenting with one or more skin lesions raising suspicion of skin cancer when noticed by the primary care physician. * Willingness and ability to provide informed consent. Exclusion Criteria: * Individuals with skin type V and VI according to the Fitzpatrick's scale (darker brown or black coloured skin)
Where it's running
-
Finspång Primary Healthcare Centre
Finspång, Docent, Sweden Recruiting -
Valla Primary Healthcare Centre
Linköping, Docent, Sweden Recruiting -
Kärna Primary Care Centre
Linköping, Docent, Sweden Recruiting -
Mjölby Primary Care Centre
Mjölby, Docent, Sweden Recruiting -
Vikbolandet Primary Care Centre
Norrköping, Docent, Sweden Recruiting -
Åby Primary Healthcare Centre
Norrköping, Docent, Sweden Recruiting
Show 2 more locations
-
Skärvet Primary Healthcare Centre
Vaxjo, Docent, Sweden Recruiting -
Ekholmen Primary Healthcare Centre
Linköping, Sweden Recruiting
Study contacts
- Study coordinator: Magnus Falk, Professor
- Email: magnus.falk@liu.se
- Phone: +46708106176
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Mobile sun protection support to help young adults stay safe in the sun
This project tests a mobile health program to see if reminders, education, planning tools, and real-time sun exposure information can help young adults protect their skin from excessive sun exposure.
-
Psycho-physiological profiling of people with low versus high heat resilience
This project will test whether controlled heat and UV exposures plus physiological and psychological measurements can identify healthy adults who are more or less resilient to heat.
-
Cosibelimab for tough CSCC in kidney transplant recipients or blood cancers
This trial tests cosibelimab in people with advanced cutaneous squamous cell carcinoma who have a kidney transplant or certain blood cancers to see if it is safe and helpful for them.
-
First-line immunotherapy and PD-L1 testing for metastatic melanoma in Slovenia
This study will see if first-line immunotherapy (pembrolizumab, nivolumab, or ipilimumab plus nivolumab) works for adults in Slovenia with metastatic melanoma and whether PD-L1 measurements predict who responds.
-
Optical and multi-modal analysis to help diagnose skin cancer
This project tests whether combining optical spectroscopy and imaging data from skin samples can help diagnose skin cancer in people with skin concerns.
-
Early skin tumor detection with telemedicine in primary care
This project will test whether a telemedicine tool used by general practitioners can help detect suspicious skin lesions earlier in people with fair skin in the Czech Republic.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.