Implementation of Teledermoscopy and Artificial Intelligence

NCT05033678 | Recruiting

• 1 other identifier: 2020-04763
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

The study has 2 parts. Part 1 will investigate the effects of introducing teledermoscopy in clinical practice, more specifically the change in referral patterns, the risk of undetected skin cancers and the effect on diagnostic accuracy in general practitioners. Part 2 will investigate how to introduce artificial intelligence (AI) within teledermocsopy. In this study the investigators will measure the diagnostic accuracy of teledermoscopic assessors that had access to the results of artificial intelligence algorithm compared to those who did not. Data will be collected through teledermoscopic referrals, patient records, national registries and questionnairs.

Conditions

Skin Cancer

Keywords

Melanoma; non-melanoma skin cancer; teledermoscopy; artificial intelligence; health care organization

Outcome Measures

Primary Outcomes (4)

• Effect on referral patterns

  Measure how referral patterns are affected by the introduction of teledermoscopy

  2 years

• Effect on diagnostic accuracy due to availability of artificial intelligence

  Measuring if the diagnostic accurcy differs depending on if physician can see the results of the artificial intelligence.

  8 years

• Risk of undetected skin cancer

  Measuring if the risk of undetected skin cancer increases with the use of teledermoscopy

  2 years

• Artificial intelligence timing and effect on diagnostic accuracy and willingness to rethink the preliminary diagnosis

  Measuring if the diagnostic accuracy and the willingness to reconsider the preliminary diagnosis differs according to when in the process a physician is presented with the results of the artificial intelligence

  8 years

Secondary Outcomes (2)

• Image enhancement techniques in teledermoscopy

  From 2021 to 2025

• When single reader evaluations are insufficient in teledermoscopy

  2021-2024

Interventions

Diagnostic algorithms DEVICE

Assessors of teledermoscopy will be randomly assigned to use the results of artificial intelligence when the assess a teledermoscopic case.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients, 15 years or older, seeking care for a suspected skin lesion, or when a suspected skin lesion is detected during a visit for another complaint, for whom a teledermoscopic consultation is created.

You may qualify if:

• Has a skin lesion assessed by a physician during a visit
• The physician decides to create a teledermoscopy referral

You may not qualify if:

• inability or unwillingness to participate in the study
• the patient is younger than 15 years old
• Images of such bad quality they cannot be assessed

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Department of dermatology, Skane University Hospital

Lund, 22185, Sweden

RECRUITING

Related Publications (1)

• Natterdahl C, Kristensson H, Persson B, Lapins J, Ivert LU, Radros N, Schultz K, Sand C, Lundgren S, Pahlow Mose A, Ingvar J, Dizdarevic A, Nielsen K, Ingvar A. When Are Single Reader Evaluations Insufficient in Teledermoscopic Assessments? Analyses of a Retrospective Cohort Study. Telemed J E Health. 2025 May;31(5):579-589. doi: 10.1089/tmj.2024.0532. Epub 2025 Jan 27.

  PMID: 39869017 DERIVED

MeSH Terms

Conditions

Skin Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas

Study Officials

• Asa Ingvar, PhD

  Department of Dermatology, Skane University Hospital, Region Skane, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asa Ingvar, PhD

CONTACT

+4646172243; asa.ingvar@skane.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 5, 2021
• Study Start: August 16, 2021
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)