[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587729":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":17,"centralContacts":24,"locations":34,"responsibleParty":153,"collaborators":156,"id":164,"slug":165,"hasResults":166,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":172,"sex":173,"minAge":174,"maxAge":17,"enrollmentInfo":175,"targetDuration":17,"studyType":178,"phases":179,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":37,"whyStopped":17,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"Linkoeping University","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Possibility to use AI support","EXPERIMENTAL","The primary care physician may use the AI decision support (Dermalyser) in their assessment of skin lesions.",[13],"Device: Artificial inteligence based decision support to detect skin cancer",{"label":15,"type":16,"description":17,"interventionNames":17},"Control","NO_INTERVENTION",null,[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":17},"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.",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":17,"email":29},"Magnus Falk, Professor","CONTACT","+46708106176","magnus.falk@liu.se",{"name":31,"role":27,"phone":32,"phoneExt":17,"email":33},"Panos Papachristou, MD, PhD","+46702298892","panos.papachristou@ki.se",[35,59,72,81,96,111,123,140],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Finspång Primary Healthcare Centre","RECRUITING","Finspång","Docent","61230","Sweden","SE",{"type":44,"coordinates":45},"Point",[46,47],15.76739,58.70578,{"lat":47,"lon":46},[50,54,57],{"name":51,"role":27,"phone":52,"phoneExt":17,"email":53},"Moa Lundgren, M.D.","+4610105 92 60","Moa.lundgren@regionostergotland.se",{"name":55,"role":56,"phone":17,"phoneExt":17,"email":17},"Magnus O Falk, M.D., Ph.D., Professor","PRINCIPAL_INVESTIGATOR",{"name":51,"role":58,"phone":17,"phoneExt":17,"email":17},"SUB_INVESTIGATOR",{"facility":60,"status":37,"city":61,"state":39,"zip":62,"country":41,"countryCode":42,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Valla Primary Healthcare Centre","Linköping","58213",{"type":44,"coordinates":64},[65,66],15.62157,58.41086,{"lat":66,"lon":65},[69,71],{"name":70,"role":27,"phone":28,"phoneExt":17,"email":29},"Magnus Falk, M.D., Ph.D., Professor",{"name":55,"role":56,"phone":17,"phoneExt":17,"email":17},{"facility":73,"status":37,"city":61,"state":39,"zip":74,"country":41,"countryCode":42,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Kärna Primary Care Centre","58662",{"type":44,"coordinates":76},[65,66],{"lat":66,"lon":65},[79,80],{"name":70,"role":27,"phone":28,"phoneExt":17,"email":29},{"name":55,"role":56,"phone":17,"phoneExt":17,"email":17},{"facility":82,"status":37,"city":83,"state":39,"zip":84,"country":41,"countryCode":42,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Mjölby Primary Care Centre","Mjölby","59530",{"type":44,"coordinates":86},[87,88],15.12365,58.32595,{"lat":88,"lon":87},[91,95],{"name":92,"role":27,"phone":93,"phoneExt":17,"email":94},"Emil Kristensen, M.D.","+4610-105 99 10","Emil.Kristensson@regionostergotland.se",{"name":55,"role":56,"phone":17,"phoneExt":17,"email":17},{"facility":97,"status":37,"city":98,"state":39,"zip":99,"country":41,"countryCode":42,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Vikbolandet Primary Care Centre","Norrköping","61024",{"type":44,"coordinates":101},[102,103],16.1826,58.59419,{"lat":103,"lon":102},[106,110],{"name":107,"role":27,"phone":108,"phoneExt":17,"email":109},"John Berglund, M.D.","+46101059280","John.berglund@regionostergotland.se",{"name":55,"role":56,"phone":17,"phoneExt":17,"email":17},{"facility":112,"status":37,"city":98,"state":39,"zip":113,"country":41,"countryCode":42,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"Åby Primary Healthcare Centre","61330",{"type":44,"coordinates":115},[102,103],{"lat":103,"lon":102},[118,122],{"name":119,"role":27,"phone":120,"phoneExt":17,"email":121},"Hanna Skytt, M.D.","+4610105 93 10","hanna.skytt@regionostergotland.se",{"name":55,"role":56,"phone":17,"phoneExt":17,"email":17},{"facility":124,"status":37,"city":125,"state":39,"zip":126,"country":41,"countryCode":42,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Skärvet Primary Healthcare Centre","Vaxjo","35234",{"type":44,"coordinates":128},[129,130],14.80906,56.87767,{"lat":130,"lon":129},[133,137,139],{"name":134,"role":27,"phone":135,"phoneExt":17,"email":136},"Jon Pallon, M.D., Ph.D.","+4647058 97 50","jon.pallon@kronoberg.se",{"name":138,"role":58,"phone":17,"phoneExt":17,"email":17},"Jon O Pallon, M.D., Ph.D.",{"name":55,"role":56,"phone":17,"phoneExt":17,"email":17},{"facility":141,"status":37,"city":61,"state":17,"zip":142,"country":41,"countryCode":42,"cosmosGeoPoint":143,"geoPoint":145,"contacts":146},"Ekholmen Primary Healthcare Centre","589 29",{"type":44,"coordinates":144},[65,66],{"lat":66,"lon":65},[147,151,152],{"name":148,"role":27,"phone":149,"phoneExt":17,"email":150},"My Söderholm, M.D.","+46768551533","my.soderholm@liu.se",{"name":55,"role":56,"phone":17,"phoneExt":17,"email":17},{"name":148,"role":58,"phone":17,"phoneExt":17,"email":17},{"type":56,"investigatorFullName":154,"investigatorTitle":155,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Magnus Falk","Professor",[157,160,162],{"name":158,"class":159},"Karolinska Institutet","OTHER",{"name":161,"class":159},"Göteborg University",{"name":163,"class":159},"Region Östergötland","100587729","artificial-intelligent-decision-support-for-skin-cancer-diagnostics-in-primary-care-100587729",false,"NCT06932172","Artificial Intelligent Decision Support for Skin Cancer Diagnostics in Primary Care","Artificial Intelligent Decision Support for Skin Cancer Diagnostics in Primary Care - a Multicentre Randomized Controlled Trial.","AI-DSSC","Inclusion Criteria:\n\n* 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.\n* Willingness and ability to provide informed consent.\n\nExclusion Criteria:\n\n* Individuals with skin type V and VI according to the Fitzpatrick's scale (darker brown or black coloured skin)",true,"ALL","18 Years",{"count":176,"type":177},3000,"ESTIMATED","INTERVENTIONAL",[180],"NA","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.\n\nProject 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.\n\nMethod: 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\u002Fbenign lesions, and morbidity and mortality in skin cancer. Possible between-group differences will be investigated statistically.\n\nPotential 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.",[183],"Skin Cancer",[185,186,187],"Artificial Intelligence (AI)","Primary care","Diagnostics","2026-01-08",{"date":190,"type":191},"2026-01-12","ACTUAL",{"date":193,"type":191},"2025-11-04",{"date":195,"type":177},"2031-12-31",{"name":5,"class":6},8]