AI Decision Support System for Detecting Skin Cancer in Primary Care A Multicenter Randomized Trial

What this Trial Is About

Researchers are evaluating an artificial intelligence AI decision support system called Dermalyser to help primary care physicians distinguish between skin cancer and benign skin lesions. This multicenter randomized controlled trial is conducted at about 30 primary care centers across Sweden, Germany, Scotland, the Netherlands, and Australia. The study aims to assess the accuracy, reliability, and clinical usefulness of Dermalyser in real clinical settings where most patients with skin lesions are managed. Participants will be assessed at primary care centers randomized to either use Dermalyser as a complementary diagnostic tool or follow the standard clinical procedure without AI support. After reaching half of the planned enrollment, centers switch from one phase to the other. Physicians can choose to use Dermalyser when they find it indicated, but the final clinical decision about lesion management remains with the physician. Both groups will be followed for up to five years to track tumor diagnoses, proportions of skin cancer versus benign lesions, and related health outcomes. During the study, participants will have their skin lesions evaluated according to either the AI-supported or standard procedure. The primary outcome measure is the proportion of skin cancers detected within six months of enrollment. Researchers will monitor morbidity and mortality related to skin cancer and compare differences between the groups. Participation may last up to five years with follow-up to assess diagnostic outcomes and safety. The study is sponsored by Linkping University.

Artificial Intelligent Decision Support for Skin Cancer Diagnostics in Primary Care