Mjolby

Researchers are evaluating an artificial intelligence (AI) decision support system called Dermalyser to help primary care physicians distinguish skin cancer from benign skin lesions. This study is a multicenter, cluster-randomized controlled trial conducted at about 30 primary care centers across Sweden, Germany, Scotland, the Netherlands, and Australia. The aim is to assess the accuracy, reliability, and clinical usefulness of Dermalyser in real-world primary care settings where most patients with skin concerns are managed. The study also explores whether using this AI tool can improve early detection of skin cancer and reduce unnecessary removal or referral of benign lesions. During the study, participating primary care centers are randomly assigned to either use the Dermalyser device as a complementary diagnostic aid (intervention phase) or follow their usual clinical assessment without AI support (control phase). After enrolling half of the planned 3000 participants (1500 patients), the centers switch phases, allowing all to experience both approaches. Physicians decide on the clinical management of lesions, with Dermalyser providing additional information only during the intervention phase. Participants are followed for up to 5 years to monitor tumor diagnoses, skin cancer rates, and related health outcomes. Participants are patients attending primary care to have suspicious skin lesions checked. Researchers will assess the proportion of skin cancers diagnosed within six months of enrollment using standard clinical procedures. Throughout the study, data on diagnoses, morbidity, and mortality related to skin cancer will be collected. This long-term follow-up aims to determine differences between those assessed with and without the AI decision support. The study results could help improve skin cancer diagnostics and patient care in primary care settings worldwide.