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Implementation of Teledermoscopy and Artificial Intelligence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05033678
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : September 17, 2021
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Region Skane

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 effect of displaying the results of artificial intelligence in different ways and at different time points.

Data will be collcted through teledermoscopic referrals, patient records, national registries and questionnairs.


Condition or disease Intervention/treatment
Skin Cancer Device: Diagnostic algorithms

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Years
Official Title: Teledermoscopy and Artificial Intelligence: Effects of Implementation in Clinical Practice
Actual Study Start Date : August 16, 2021
Estimated Primary Completion Date : August 31, 2029
Estimated Study Completion Date : August 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer


Intervention Details:
  • Device: Diagnostic algorithms
    Assessors of teledermoscopy will be asked to review the results of artificial intelligence displayed differently and at different time points in their assessment.


Primary Outcome Measures :
  1. Effect on referral patterns [ Time Frame: 2 years ]
    Measure how referral patterns are affected by the introduction of teledermoscopy

  2. Effect on diagnostic accurcay in general practioners [ Time Frame: 2 years ]
    Measuring how the continuous use of teledermoscopy affects the diagnostic accuracy in general practitioners

  3. Risk of undetected skin cancer [ Time Frame: 2 years ]
    Measuring if the risk of undetected skin cancer increases with the use of teledermoscopy

  4. Effect on diagnostic accuracy due to different display of artificial intelligence [ Time Frame: 8 years ]
    Measuring if the diagnostic accurcy differs depending on how artificial intelligence is presented to the physician

  5. Artificial intelligence timing and effect on diagnostic accuracy and willingness to rethink the preliminary diagnosis [ Time Frame: 8 years ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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, and it is decided to send a teledermoscopic consultation.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • inability or unwillingness to participate in the study
  • the patient is younger than 15 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05033678


Contacts
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Contact: Asa Ingvar, PhD +4646172243 asa.ingvar@skane.se

Locations
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Sweden
Tabelund vardcentral Not yet recruiting
Eslov, Sweden
Contact: Gabriella Caleres         
Capio vardcentral Helsingborg Recruiting
Helsingborg, Sweden
Contact: Linda Sundlöf         
Lomma vardcentral Recruiting
Lomma, Sweden
Contact: Mohammad Oskooi         
Department of dermatology, Skane University Hospital Active, not recruiting
Lund, Sweden, 22185
Helsa/ Kry vårdcentral Recruiting
Lund, Sweden, 22223
Contact: Jonas Ingvar         
Masen vardcentral Recruiting
Lund, Sweden, 22732
Contact: Henrik Orre         
Bokskogen vardcentral Recruiting
Malmö, Sweden
Contact: Jenny Wittrup         
Lideta vardcentral Recruiting
Malmö, Sweden
Contact: Esther Millar         
Sjobo vardcentral Recruiting
Sjobo, Sweden, 27531
Contact: Celestina Wiberg         
Halsomedicinskt center Staffanstorp Recruiting
Staffanstorp, Sweden, 24532
Contact: Mette Barth         
Staffastorps vardcentral Recruiting
Staffanstorp, Sweden
Contact: Cecilia Luts         
Sponsors and Collaborators
Region Skane
Lund University
Investigators
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Principal Investigator: Asa Ingvar, PhD Department of Dermatology, Skane University Hospital, Region Skane, Sweden
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT05033678    
Other Study ID Numbers: 2020-04763
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Skane:
Melanoma
non-melanoma skin cancer
teledermoscopy
artificial intelligence
health care organization
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases