NCT06932172 Artificial Intelligent Decision Support for Skin Cancer Diagnostics in Primary Care
| NCT ID | NCT06932172 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Linkoeping University |
| Condition | Skin Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,000 participants in total. It began in 2025-11-04 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06932172 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Skin Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06932172 currently recruiting?
Yes, NCT06932172 is actively recruiting participants. Contact the research team at magnus.falk@liu.se for enrollment information.
Where is the NCT06932172 trial being conducted?
This trial is being conducted at Finspång, Sweden, Linköping, Sweden, Linköping, Sweden, Mjölby, Sweden and 4 additional locations.
Who is sponsoring the NCT06932172 clinical trial?
NCT06932172 is sponsored by Linkoeping University. The trial plans to enroll 3,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.