Artificial Intelligent Decision Support for Skin Cancer Diagnostics in Primary Care

Sponsor
Linkoeping University
Study ID
NCT06932172
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Artificial inteligence based decision support to detect skin cancer — DEVICE
    When assessing skin lesions in patients seeking primary care, the primary care physician may use the device to be evaluated in the study (Dermalyser) as a complementary diagnostic doecision support to differentiate skin cancers from benign skin lesions. However, the decision on clinical management of the lesion remains with the physician.

Study Details

Background: Artificial intelligence has in numerous studies shown high accuracy in detecting skin cancer when trained on various databases of dermatoscopic images. However, there are very few prospective studies conducted in real clinical settings directed at patients seeking healthcare for assessment of skin lesions, and nosuch studies at all in primary care, where the majority of patients are managed. Project aim: To study the accuracy, reliability, and clinical utility of an AI-based decision support system (Dermalyser), developed for primary care, in distinguishing skin cancer from benign lesions. Method: Cluster-randomized controlled trial at approx. 30 primary care centers in Sweden, Germany, Scotland, the Netherlands and Australia. At study start, the participating primary care centres in each country are equally randomised to either be enabled to use the Dermalyser (intervention phase) or to assess patients according to the standard clinical procedure (control phase). When half of the intended sample size (i.e. 1500 of 3000 participants) have been included, the primary care centres switch phase from intervention to control, or vice versa. During the intervention phase, the physicians may use (if found indicated) Dermalyser as a part of their clinical evaluation, whereas during the control phase the physicians follow their ordinary diagnostic routine without support from Dermalyser. This will direct the participants to either an intervention or a control cohort. Both groups will be followed for up to 5 years, with regard to the tumour diagnoses, proportions of skin cancer/benign lesions, and morbidity and mortality in skin cancer. Possible between-group differences will be investigated statistically. Potential benefits: If the Dermalyser prooves to be safe and diagnotically reliability, it could enhance the chance of detecting skin cancer in early stage in primary care, and to reduce the proportion of benign skin lesion unnecessarily excised or referred to dermatologist.

Key Dates

First listed
Apr 17, 2025
Start date
Nov 4, 2025
Status verified
Jan 2026
Primary completion
May 31, 2027
Completion
Dec 31, 2031

Study Design

Enrollment
3,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Possibility to use AI support
    The primary care physician may use the AI decision support (Dermalyser) in their assessment of skin lesions.
  • No Intervention: Control

Primary Outcome Measure

Proportion of skin cancers [ Time Frame: From enrollment until all included lesions have been diagnosed following standard clinical investigation procedure, which we consider in the normal case will not exceed 6 months from inclusion. ]

Central Contacts

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