Artificial Intelligent Decision Support for Skin Cancer Diagnostics in Primary Care (AI-DSSC)

January 8, 2026 updated by: Magnus Falk, Linkoeping University

Artificial Intelligent Decision Support for Skin Cancer Diagnostics in Primary Care - a Multicentre Randomized Controlled Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Linköping, Sweden, 589 29
        • Recruiting
        • Ekholmen Primary Healthcare Centre
        • Principal Investigator:
          • Magnus O Falk, M.D., Ph.D., Professor
        • Contact:
        • Sub-Investigator:
          • My Söderholm, M.D.
    • Docent
      • Finspång, Docent, Sweden, 61230
        • Recruiting
        • Finspång Primary Healthcare Centre
        • Contact:
        • Principal Investigator:
          • Magnus O Falk, M.D., Ph.D., Professor
        • Sub-Investigator:
          • Moa Lundgren, M.D.
      • Linköping, Docent, Sweden, 58213
        • Recruiting
        • Valla Primary Healthcare Centre
        • Principal Investigator:
          • Magnus O Falk, M.D., Ph.D., Professor
        • Contact:
          • Magnus Falk, M.D., Ph.D., Professor
          • Phone Number: +46708106176
          • Email: magnus.falk@liu.se
      • Linköping, Docent, Sweden, 58662
        • Recruiting
        • Kärna Primary Care Centre
        • Principal Investigator:
          • Magnus O Falk, M.D., Ph.D., Professor
        • Contact:
          • Magnus Falk, M.D., Ph.D., Professor
          • Phone Number: +46708106176
          • Email: magnus.falk@liu.se
      • Mjölby, Docent, Sweden, 59530
        • Recruiting
        • Mjölby Primary Care Centre
        • Principal Investigator:
          • Magnus O Falk, M.D., Ph.D., Professor
        • Contact:
      • Norrköping, Docent, Sweden, 61024
        • Recruiting
        • Vikbolandet Primary Care Centre
        • Principal Investigator:
          • Magnus O Falk, M.D., Ph.D., Professor
        • Contact:
      • Norrköping, Docent, Sweden, 61330
        • Recruiting
        • Åby Primary Healthcare Centre
        • Principal Investigator:
          • Magnus O Falk, M.D., Ph.D., Professor
        • Contact:
      • Vaxjo, Docent, Sweden, 35234
        • Recruiting
        • Skärvet Primary Healthcare Centre
        • Principal Investigator:
          • Magnus O Falk, M.D., Ph.D., Professor
        • Contact:
        • Sub-Investigator:
          • Jon O Pallon, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Possibility to use AI support
The primary care physician may use the AI decision support (Dermalyser) in their assessment of skin lesions.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Proportion of skin cancers (melanoma, SCC or BCC) excised or referred to dermatologists, as described in percentage of total number of skin lesions included.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Collaborators

Karolinska Institutet
Göteborg University
Region Östergötland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIV-23-03-042574
  • 2023-05996 (Other Grant/Funding Number: The Swedish Research Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication.

IPD Sharing Time Frame

Prior to study start (protocol, SAP, ICF) and at completion (CSR).

IPD Sharing Access Criteria

Provided a proper description of intended use (e.g. use for meta analysis, including description of study aim and design).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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