Clinical trial Recruiting at 8 sites Interventional Ages 18 and up

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.

More Skin Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment3000 (estimated)
SponsorLinkoeping University
Government
Locations8 sites (Finspång, Docent and 7 other locations)
StatusRecruiting
StartedNovember 4, 2025
Main results expectedMay 31, 2027
Study endsDecember 31, 2031
Registry record updatedJanuary 12, 2026
Trial IDNCT06932172 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.