Artificial Intelligent Decision Support for Skin Cancer Diagnostics in Primary Care
NCT ID: NCT06932172
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3000 participants
INTERVENTIONAL
2025-11-04
2031-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Possibility to use AI support
The primary care physician may use the AI decision support (Dermalyser) in their assessment of skin lesions.
Artificial inteligence based decision support to detect skin cancer
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.
Control
No interventions assigned to this group
Interventions
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Artificial inteligence based decision support to detect skin cancer
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.
Eligibility Criteria
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Inclusion Criteria
* Willingness and ability to provide informed consent.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Karolinska Institutet
OTHER
Göteborg University
OTHER
Region Östergötland
OTHER
Linkoeping University
OTHER_GOV
Responsible Party
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Magnus Falk
Professor
Locations
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Finspång Primary Healthcare Centre
Finspång, Docent, Sweden
Valla Primary Healthcare Centre
Linköping, Docent, Sweden
Kärna Primary Care Centre
Linköping, Docent, Sweden
Mjölby Primary Care Centre
Mjölby, Docent, Sweden
Vikbolandet Primary Care Centre
Norrköping, Docent, Sweden
Åby Primary Healthcare Centre
Norrköping, Docent, Sweden
Skärvet Primary Healthcare Centre
Vaxjo, Docent, Sweden
Ekholmen Primary Healthcare Centre
Linköping, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Helenason J, Ekstrom C, Falk M, Papachristou P. Exploring the feasibility of an artificial intelligence based clinical decision support system for cutaneous melanoma detection in primary care - a mixed method study. Scand J Prim Health Care. 2024 Mar;42(1):51-60. doi: 10.1080/02813432.2023.2283190. Epub 2024 Feb 7.
Papachristou P, Soderholm M, Pallon J, Taloyan M, Polesie S, Paoli J, Anderson CD, Falk M. Evaluation of an artificial intelligence-based decision support for the detection of cutaneous melanoma in primary care: a prospective real-life clinical trial. Br J Dermatol. 2024 Jun 20;191(1):125-133. doi: 10.1093/bjd/ljae021.
Other Identifiers
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2023-05996
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CIV-23-03-042574
Identifier Type: -
Identifier Source: org_study_id
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